https://www.biodextris.com https://www.biodextris.com/biodextris-appoints-dr-behzad-mahdavi-as-executive-chairman-to-lead-global-commercial-expansion <div data-rss-type="text"> Biodextris Appoints Dr. Behzad Mahdavi as Executive Chairman &amp; Chief Commercial Officer <div> <br/> </div> <div> Who: Dr. Behzad Mahdavi, Ph.D., MBA, NACD.DC — a biopharma industry veteran with over 25 years of senior leadership experience in CDMO and CRO sectors, including roles at Lonza and Catalent. </div> <div> <br/> </div> <div> What: He has been appointed Executive Chairman and will additionally serve as Chief Commercial Officer at Biodextris. </div> <div> <br/> </div> <div> Why: Dr. Mahdavi will spearhead the company’s global commercial expansion, leveraging his expertise in commercial innovation and international market development  </div> <div> <br/> </div> <div> About Biodextris: Headquartered in Laval (Montréal), Québec, Biodextris is a rising Contract Development &amp; Manufacturing Organization (CDMO) specializing in biologics and vaccine development, rooted in the legacy of GSK’s biologics and supported by ArchiMed private equity. </div> <div> <br/> </div> <div> For full details, you can read the original PR Newswire article here: </div> <div> <br/> </div> <div> <a href="https://www.prnewswire.com/news-releases/biodextris-appoints-dr-behzad-mahdavi-as-executive-chairman-to-lead-global-commercial-expansion-302472664.html"> https://www.prnewswire.com/news-releases/biodextris-appoints-dr-behzad-mahdavi-as-executive-chairman-to-lead-global-commercial-expansion-302472664.html </a> </div> </div> Wed, 11 Jun 2025 17:38:41 GMT https://www.biodextris.com/biodextris-appoints-dr-behzad-mahdavi-as-executive-chairman-to-lead-global-commercial-expansion thumbnail main image https://www.biodextris.com/aramis-biotechnologies-and-biodextris-announce-partnership Learn about the strategic partnership between Aramis Biotechnologies and Biodextris to advance vaccine and biologics development. <h3> Downstream manufacturing agreement for Virus-Like Particle Vaccine  Phase 1 &amp; 2 Clinical Trials  </h3> <div data-rss-type="text"> Quebec City, December 17th, 2024 – Aramis Biotechnologies Inc. ("Aramis"), a Quebec City-based company specialized in plant-based biomanufacturing of innovative vaccines, and Biodextris Inc. (“Biodextris”), a Montreal-based CDMO specialized in cGMP complex biologic products, are excited to announce the signature of an agreement. This strategic partnership will leverage the expertise of both companies to ensure efficient downstream manufacturing of clinical materials for Aramis’ leading product candidate, a seasonal influenza vaccine with the potential to improve the protection of at-risk populations.  <div> <br/> </div> <div> Under the terms of the agreement, Biodextris will provide Aramis with access to its state-of-the-art facilities and industry-leading capabilities to ensure the timely production of high-quality materials for Aramis’ forthcoming Phase 1 &amp; 2 clinical trials. The downstream manufacturing agreement marks an important milestone in the ongoing collaboration between Aramis and Biodextris, combining cutting-edge science and manufacturing excellence to drive success in clinical development.  </div> <div> <br/> </div> <div> "We are delighted to be working with Biodextris as partner for downstream manufacturing and supply of clinical material" said Aramis’ Co-founder &amp; CEO, Frédéric Ors. "This partnership is aligned with Aramis’ business model to use the best external expertise and capabilities, and prepare operations scale-up for potential pandemic response. From the initial proposal through to the extensive collaboration to date, we’ve been impressed by Biodextris’ partnership-centric approach to identifying and solving technical challenges, as well as their commitment to the highest quality standards, making them an ideal partner for clinical-scale production of our influenza vaccine candidate.”  </div> <div> <br/> </div> <div> "It’s a pleasure to be chosen as Aramis’ development and downstream manufacturing partner in their mission to revolutionize vaccines” says Cédric Héroux, Biodextris’ GM. “The Aramis team’s deep scientific expertise and passion for health impact, both in Canada and at a global level, has resonated deeply with Biodextris since the start of our collaboration, and we look forward to working with them to make these vaccines accessible to patients.”  </div> <div> <br/> </div> <div> <b> About Aramis Biotechnologies  </b> </div> <div> Based in Quebec City, Aramis Biotechnologies is a Canadian company founded in 2023 that specializes in plant-based production of innovative vaccines. As a majority employee-owned company, our ambition is to develop innovative and sustainable solutions to current and future public health challenges. The Aramis’ team is grateful for the support from Innovation, Sciences and Economic Development Canada and from the City of Quebec.  </div> <div> <br/> </div> <div>   </div> <div> <br/> </div> <div> <b> About Biodextris Inc.  </b> </div> <div> Biodextris is a cGMP complex biologics CDMO with over 20 years’ experience in the development, GMP manufacturing, and bioanalysis of high-value complex biologic products. With customers ranging from the largest global Biopharmaceutical companies to university spin-outs, Biodextris is the partner of choice for innovative Biotechnology companies with novel or complex processes looking to accelerate their path to clinic &amp; commercialization. Biodextris’ new center of excellence in Laval, supporting customers in manufacturing and analysis from pre-clinical development through to commercialization, was developed with the support of the governments of Quebec and Canada, as well as Investissement Québec.  </div> <div> <br/> </div> <div> For more information:  </div> <div> aramisbiotechnologies.com  </div> <div> biodextris.com   </div> </div> Tue, 17 Dec 2024 14:56:01 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/aramis-biotechnologies-and-biodextris-announce-partnership English thumbnail main image https://www.biodextris.com/fr/aramis-biotechnologies-and-biodextris-announce-partnership Clean Biologics acquires Biodextris—bringing together expertise in biologics manufacturing and accelerating growth in CDMO services. <h3> Accord de fabrication en aval d’un vaccin à particules pseudovirales pour des essais cliniques de Phase 1 et 2  </h3> <div data-rss-type="text"> Québec, le 17 décembre 2024 - Aramis Biotechnologies Inc. (« Aramis »), une entreprise de Québec spécialisée dans la production de vaccins innovants produits dans les plantes, et Biodextris Inc. (« Biodextris »), un CDMO de Montréal spécialisé dans les produits biologiques complexes conformes aux BPF, sont heureux d'annoncer la signature d'une entente. Ce partenariat stratégique s'appuiera sur l'expertise des deux sociétés pour assurer une fabrication en aval efficace du matériel clinique pour le produit candidat principal d'Aramis, un vaccin contre la grippe saisonnière ayant le potentiel d'améliorer la protection des populations à risque.  <div> <br/> </div> <div> Selon les termes de l'accord, Biodextris fournira à Aramis l'accès à ses installations de pointe et à ses capacités industrielles de premier plan afin d'assurer la production en temps voulu de matériel de haute qualité pour les prochains essais cliniques de phase 1 et 2 d'Aramis. L'accord de fabrication en aval marque une étape importante dans la collaboration en cours entre Aramis et Biodextris, combinant science de pointe et excellence de la production pour assurer le succès du développement clinique.  </div> <div> <br/> </div> <div> « Nous sommes ravis de travailler avec Biodextris en tant que partenaire pour la fabrication en aval et l’approvisionnement de matériel clinique », a déclaré Frédéric Ors, cofondateur et chef de la direction d'Aramis. « Ce partenariat s'inscrit dans le modèle d’affaires d'Aramis, qui consiste à utiliser les meilleures compétences et capacités externes, et à préparer la mise à l’échelle des opérations en vue d'une éventuelle réponse à une pandémie. Depuis la proposition initiale jusqu'à la collaboration approfondie à ce jour, nous avons été impressionnés par l'approche centrée sur le partenariat de Biodextris pour identifier et résoudre les défis techniques, ainsi que par son engagement à respecter les normes de qualité les plus élevées, ce qui en fait un partenaire idéal pour la production à l'échelle clinique de notre candidat-vaccin contre la grippe. »  </div> <div> « C'est un plaisir d'être choisi comme partenaire d'Aramis pour le développement et la fabrication en aval dans sa mission de révolutionner les vaccins », déclare Cédric Héroux, directeur général de Biodextris. « L'expertise scientifique approfondie de l'équipe d'Aramis et sa passion pour l'impact sur la santé, tant au Canada qu'au niveau mondial, ont trouvé un écho profond auprès de Biodextris depuis le début de notre collaboration, et nous sommes impatients de travailler avec eux pour rendre ces vaccins accessibles aux patients. »  </div> <div> <br/> </div> <div> <b> À propos d’Aramis Biotechnologies </b>   </div> <div> Basée à Québec, Aramis Biotechnologies est une entreprise canadienne fondée en 2023 qui se spécialise dans la production de vaccins innovants produits dans les plantes. En tant qu’entreprise à capital majoritairement détenu par nos employés-actionnaires, notre ambition est de développer des solutions novatrices et durables pour répondre aux défis de santé publique actuels et futurs.  L'équipe d'Aramis est reconnaissante du soutien apporté par Innovation, Sciences et Développement économique Canada et par la Ville de Québec.  </div> <div> <br/> </div> <div> <b> À propos de Biodextris Inc.  </b> </div> <div> Biodextris est un CDMO de produits biologiques complexes conformes aux BPF avec plus de 20 ans d'expérience dans le développement, la fabrication BPF et la bioanalyse de produits biologiques complexes de grande valeur. Avec des clients allant des plus grandes sociétés biopharmaceutiques mondiales aux entreprises dérivées d’universités, Biodextris est le partenaire de choix pour les sociétés de biotechnologie innovantes avec des processus nouveaux ou complexes qui cherchent à accélérer leur chemin vers la clinique et la commercialisation. Le nouveau centre d'excellence de Biodextris à Laval, qui soutient les clients dans la fabrication et l'analyse depuis le développement préclinique jusqu'à la commercialisation, a été développé avec le soutien des gouvernements du Québec et du Canada, ainsi que d'Investissement Québec.  </div> <div> <br/> </div> <div> Pour plus d’informations:  </div> <div> aramisbiotechnologies.com  </div> <div> biodextris.com   </div> </div> Tue, 17 Dec 2024 14:55:57 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/fr/aramis-biotechnologies-and-biodextris-announce-partnership French thumbnail main image https://www.biodextris.com/fr/inauguration-installations-biotech-laval Biodextris inaugure de nouvelles installations à Laval pour renforcer son expertise en développement biologique. <div data-rss-type="text"> Laval, le 4 octobre 2024 – En présence d’Annie Koutrakis, députée de Vimy et secrétaire parlementaire de l’honorable Soraya Martinez Ferrada, ministre du Tourisme et ministre responsable de Développement économique Canada pour les régions du Québec, de Christopher Skeete, ministre délégué à l’Économie, ministre responsable de la Lutte contre le racisme et ministre responsable de la région de Laval, et de Guylaine Rose, directrice régionale de Laval et l’Outaouais d’Investissement Québec, Biodextris Inc. est fier d’inaugurer aujourd’hui ses tout nouveaux laboratoires situés en plein cœur de la Cité de la Biotech à Laval.  <div> <br/> </div> <div> Ces nouvelles installations sont le fruit d’investissements de près de 25 millions de dollars et marquent le début d'une nouvelle ère pour l’entreprise québécoise spécialisée dans le développement, la fabrication clinique et le conditionnement (CDMO), à l’échelle industrielle, de vaccins et de produits biologiques, au service des biotech et entreprises pharmaceutiques. <div> <br/> <div> « C’est avec une immense fierté que nous inaugurons ces nouvelles installations. Ce déménagement représente bien plus qu’un simple changement de lieu ; il symbolise notre engagement envers l’innovation et notre volonté de continuer à grandir tout en restant fidèles à notre approche client centrée sur les relations humaines », a déclaré Cédric Héroux le directeur général de Biodextris. </div> <div> <br/> </div> <div> Fondée en 2015, Biodextris Inc. est le résultat de l'initiative de trois scientifiques entrepreneurs québécois. À la suite de la fermeture du centre de recherche de l’entreprise GSK et partis de l’héritage de cette dernière, les fondateurs ont choisi de persévérer et de poursuivre certaines opérations, ici au Québec, afin d’y maintenir des emplois de qualité.  </div> <div> <br/> </div> <div> Aujourd’hui, Biodextris Inc. compte plus de 40 employés et se distingue par son professionnalisme, une approche personnalisée envers ses clients et sa capacité à travailler avec des produits complexes. La pandémie, en recentrant l'attention sur les vaccins et les traitements issus de la biotechnologie, a permis de stimuler une phase d'expansion pour l'entreprise. Cet important développement illustre le parcours remarquable de Biodextris, axé sur l'excellence et l'engagement, dont la contribution à la croissance de l'industrie des sciences de la vie au Québec est au cœur de sa mission. </div> <div> <br/> </div> <div> Situé au cœur de la Cité de la Biotech de Laval, le bâtiment existant a été aménagé sur mesure pour répondre aux besoins spécifiques de Biodextris Inc. Le projet a reçu un soutien de 4 millions de dollars dans le cadre du programme ESSOR, administré par Investissement Québec à titre de mandataire du gouvernement du Québec, et de 3 millions via les fonds propres d’Investissement Québec. À ces aides financières s’ajoute un montant de 900 000 $ du gouvernement du Canada via Développement économique Canada pour les régions du Québec (DEC). </div> <div> <br/> </div> <div> « Investissement Québec est fier de soutenir les entreprises qui contribuent à renforcer l'écosystème des sciences de la vie au Québec. Le projet de Biodextris illustre ce que peut accomplir une entreprise lorsque l'innovation et la croissance sont au cœur de sa mission. Cette expansion permettra non seulement d'accroître la productivité de l’entreprise, mais aussi de répondre à un besoin stratégique au sein de notre économie. » - Bicha Ngo, présidente-directrice générale d’Investissement Québec. </div> <div> <br/> </div> <div> Les différents investissements permettront entre autres à Biodextris Inc. de non seulement quadrupler sa capacité de production, avec une expansion de la superficie de 8 000 à 32 000 pieds carrés, mais également d'augmenter son effectif de 44 à 65 employés d'ici trois à cinq ans. Enfin, cette expansion permettra l'ajout d'une toute nouvelle division dédiée au développement et à la fabrication de lots cliniques de produits biothérapeutiques basés sur la technologie de l'ARN messager et de plasmides.  </div> <div> <br/> </div> <div> « Notre gouvernement est fier d’investir 4 millions de dollars chez Biodextris pour ses nouvelles installations à la pointe de la technologie. Nous continuerons de soutenir les entreprises d’ici qui font briller le Québec dans le domaine des sciences de la vie », a souligné Christine Fréchette, ministre de l’Économie, de l’Innovation et de l’Énergie et ministre responsable du Développement économique régional.  </div> <div> <br/> </div> <div> « Avec ses infrastructures de qualité et ses professionnels expérimentés, Biodextris contribue au dynamisme des sciences de la vie au Québec. En appuyant l’aménagement de leurs nouveaux locaux, nous renforçons encore la position de Laval comme pôle d’innovation dans ce domaine », a déclaré Christopher Skeete, ministre délégué à l’Économie, ministre responsable de la Lutte contre le racisme et ministre responsable de la région de Laval. </div> <div> <br/> </div> <div> « Notre gouvernement s’est engagé à investir pour s’assurer que nos PME demeurent compétitives et innovantes. Grâce à l’appui de DEC, Biodextris pourra augmenter sa capacité de production, améliorer sa compétitivité et continuer de faire innover le domaine des sciences de la vie. Nous sommes là pour appuyer les travailleurs et les PME québécoises et canadiennes en les aidant à bien s’outiller pour bâtir ensemble une économie plus forte, résiliente et durable », a déclaré Annie Koutrakis, députée de Vimy et secrétaire parlementaire de la ministre du Tourisme et ministre responsable de DEC. </div> <div> <br/> </div> <div> L’ouverture des nouvelles installations de Biodextris Inc. illustre non seulement le succès de l'entreprise, mais aussi son engagement constant envers l'innovation et l'excellence dans le domaine des sciences de la vie, témoignant ainsi de l'environnement favorable au développement de ce type d'entreprise au Québec.  </div> <div> <br/> </div> <div> « L'inauguration des nouvelles installations de Biodextris Inc. à Laval est une fierté pour notre ville. Cela démontre notre engagement à soutenir l'innovation et le développement économique dans le secteur des sciences de la vie. Nous sommes ravis d'accueillir cette expansion significative qui renforce notre position en tant que Cité de la Biotech de premier plan », a déclaré Stéphane Boyer, maire de Laval. </div> <div> <br/> </div> <div> <span> À propos de Biodextrix Inc.  </span> </div> <div> <br/> </div> <div> Fondée en 2015, Biodextris Inc, soutenue par Achimed Investisseur mondial dans l’industrie de la santé, fournit des services d’analyse et de développement de processus de fabrication clinique et des tests de contrôle de la qualité pour des clients des industries des vaccins et des produits biologiques. L’entreprise regroupe des scientifiques expérimentés en développement de produits biologiques et les principaux membres de l’équipe ont travaillé ensemble dans des entreprises de développement et fabrication de vaccins de moyenne et grande taille durant près de vingt ans. L’équipe de Biodextris offre son expertise des grandes entreprises pharmaceutiques dans un cadre de fonctionnement plus personnel et interactif à ses clients de tailles diverses. L’entreprise développe, fabrique et teste une large gamme de produits biologiques en vue d’applications vaccinales, pharmaceutiques et autres. Biodextris dispose de l’expérience et de l’expertise nécessaires au développement de produits de haute qualité, robustes et commercialisables, tout en conservant la flexibilité et le sens de l’urgence nécessaires aux petites organisations. </div> <div> <br/> </div> </div> </div> </div> Wed, 09 Oct 2024 18:57:00 GMT https://www.biodextris.com/fr/inauguration-installations-biotech-laval French thumbnail main image https://www.biodextris.com/biodextris-inc-inaugurates-its-new-facilities-in-the-heart-of-laval-s-biotech-city Biodextris inaugurates its new Laval facility in Biotech City, expanding its capabilities in biologics development and manufacturing. <div data-rss-type="text"> Laval, October 4, 2024 – In the presence of Annie Koutrakis, Member of Parliament for Vimy and Parliamentary Secretary to the Honourable Soraya Martinez Ferrada, Minister of Tourism and Minister responsible for Canada Economic Development Regions for Quebec regions, Christopher Skeete, Minister for the Economy, Minister Responsible for the Fight Against Racism, and Minister Responsible for the Laval Region, and Guylaine Rose, Regional Director for Laval and Outaouais at Investissement Québec, Biodextris Inc. proudly inaugurates its brand new laboratories in the heart of Laval's Biotech City. These new facilities, resulting from nearly $25 million in investments, mark the beginning of a new era for the Quebec-based company specializing in the development, clinical manufacturing, and packaging of vaccines and biologics for biotech and pharmaceutical companies. <div> <br/> </div> <div> “We are extremely proud to inaugurate these new facilities. This move represents much more than a simple change of location; it symbolizes our commitment to innovation and our desire to continue growing while remaining true to our customer-focused approach centered on human relationships,” said Cédric Héroux, CEO of Biodextris. </div> <div> <br/> </div> <div> Founded in 2015, Biodextris Inc. was the initiative of three entrepreneurial scientists from Quebec. Following the closure of GSK's enterprise and leveraging the company’s legacy, the founders chose to persevere and continue certain operations locally, ensuring the retention of high-quality jobs. Today, Biodextris Inc. employs over 40 people and stands out for its professionalism, personalized customer approach, and expertise in working with complex products. The pandemic, which refocused global attention on biotechnology-based vaccines and treatments, spurred the company's expansion. This growth phase reflects Biodextris' remarkable commitment to excellence and its mission to contribute to the advancement of Quebec’s life sciences industry. </div> <div> <br/> </div> <div> Located in the heart of Laval’s Biotech City, the custom-designed facility was built to meet Biodextris’ specific needs. The project received $4 million in support from the ESSOR program, administered by Investissement Québec on behalf of the Government of Quebec, along with an additional $3 million directly from Investissement Québec. Furthermore, the Government of Canada, through CED, is providing $900,000. </div> <div> <br/> </div> <div> “Investissement Québec is proud to support companies that strengthen Quebec’s life sciences ecosystem. Biodextris' project illustrates what can be achieved when innovation and growth are at the heart of a company’s mission. This expansion will not only boost the company’s productivity but also address a strategic need within our economy,” said Bicha Ngo, President and CEO of Investissement Québec. </div> <div> <br/> </div> <div> These investments will allow Biodextris Inc. to quadruple its production capacity, expanding from 8,000 to 32,000 square feet, and increase its workforce from 44 to 65 employees over the next three to five years. Additionally, this expansion will introduce a new division dedicated to the development and production of clinical batches of biotherapeutics, utilizing messenger RNA and plasmid technologies. </div> <div> <br/> </div> <div> “Our government is proud to invest $4 million in Biodextris' cutting-edge new facilities. We will continue to support local companies that help Quebec shine in the life sciences sector,” said Christine Fréchette, Minister of the Economy, Innovation and Energy, and Minister Responsible for Regional Economic Development. </div> <div> <br/> </div> <div> “With its high-quality infrastructure and experienced professionals, Biodextris contributes to the vitality of Quebec’s life sciences industry. By supporting the development of their new facilities, we are reinforcing Laval’s role as a hub of innovation in this field,” said Christopher Skeete, Minister for the Economy, Minister Responsible for the Fight Against Racism, and Minister Responsible for the Laval Region. </div> <div> <br/> </div> <div> “Our government is committed to investing to ensure our SMEs remain competitive and innovative. Thanks to CED’s support, Biodextris will be able to increase its production capacity, improve its competitiveness and continue to foster innovation in the life sciences field. We are here to support workers and Quebec and Canadian SMEs by helping them equip themselves with what they need so that, together, we can build a stronger, more resilient, more sustainable economy,” stated Annie Koutrakis, Member of Parliament for Vimy and Parliamentary Secretary to the Minister of Tourism and Minister responsible for CED. </div> <div> <br/> </div> <div> The opening of Biodextris Inc.’s new facilities not only illustrates the company’s success but also its ongoing commitment to innovation and excellence in life sciences, showcasing Quebec’s supportive environment for the development of such enterprises. </div> <div> <br/> </div> <div> “The inauguration of Biodextris Inc.’s new facilities in Laval is a source of pride for our city. It underscores our commitment to supporting innovation and economic development in the life sciences sector. We are thrilled to welcome this important expansion, which further strengthens our position as a leading Biotech City,” said Stéphane Boyer, Mayor of Laval. </div> <div> <br/> </div> <div> <span> About Biodextris Inc. </span> </div> <div> <br/> </div> <div> Founded in 2015, Biodextris Inc. is a subsidiary of Clean Biologics SAS, which provides clinical manufacturing process analysis and development services and quality control testing for clients in the vaccine and biologics industries. The company is staffed by experienced biologics development scientists, and key team members have worked together in medium and large vaccine development and manufacturing companies for almost twenty years.  </div> <div> <br/> </div> <div> The Biodextris team provides its extensive pharmaceutical company expertise in a more personal and interactive setting to clients of various sizes. The company develops, manufactures, and tests a wide range of biological products for vaccine, pharmaceutical, and other applications. Biodextris has the experience and expertise to develop high-quality, robust, and marketable products, while acting with the flexibility and sense of urgency required by small organizations. </div> <div> <br/> </div> </div> Wed, 09 Oct 2024 18:55:11 GMT https://www.biodextris.com/biodextris-inc-inaugurates-its-new-facilities-in-the-heart-of-laval-s-biotech-city English thumbnail main image https://www.biodextris.com/gmp-capabilities-in-mass-spectrometry-with-the-waters-xevo-g3-qtof Discover Biodextris' new cGMP biomanufacturing and analytical facility. Check out our state-of-the-art capabilities. <div data-rss-type="text"> Biologics have transformed healthcare with their remarkable therapeutic potential and specificity. To develop and market these biopharmaceuticals effectively, a deep understanding of product variability, degradation pathways, and production processes is essential, all of which made possible by methods such as mass spectrometry under GMP. Analytical labs face the challenge of optimizing instrument utilization to meet the demand for precise qualitative and quantitative data. This necessitates versatile multifunctional equipment that can adapt to diverse applications, such as GMP-ready Liquid Chromatography-Mass Spectrometry/(LC-MS) for comprehensive testing of biologics, enabling detailed characterization and quantitative analysis to ensure product quality and safety.  <div> <br/> <div> The Xevo G3 QTof system is precisely that - a versatile and advanced tool for mass spectrometry under GMP, characterizing and measuring molecules in various fields, including biotherapeutics, forensics, metabolite identification, metabolomics, and extractables and leachable analysis. Maintaining GMP compliance with such powerful tool is a challenge in itself, however, the Xevo G3 QTof system paired with its Waters connect software allows for data integrity levels that meet the requirements of the 21 CFR part 11. </div> <div> <br/> </div> <div> At Biodextris, we provide an extensive array of thorough analyses for detecting and quantifying a broad spectrum of substances, from small molecules to intricate biotherapeutic compounds, in R&amp;D or clinical contexts. GMP mass spectrometry using the Xevo G3 QTof thus complements our QC expertise, allowing for the analysis of post-translation modification and high-throughput intact mass screening, while ensuring data integrity. </div> <div> <br/> </div> <div> <div> <b> <font> <span> <font> Post-Translational Modification Analysis  </font> </span> </font> </b> </div> <div> <b> <font> <br/> </font> </b> </div> <div> <font color="#212b37"> Multi-attribute method (MAM) assays using GMP-ready LC-MS are becoming more popular in the biopharmaceutical industry due to their ability to directly measure various characteristics, such as product variability and degradation. Through the utilization of improved ion optics and beam conditioning, our mass spectrometry system under GMP enhances peptide transmission, allowing for comprehensive quantification. This increased precision streamlines the process for extensive peptide mapping and dependable quantification of attributes like deamidation, oxidation, lysine clipping, and glycosylation. Furthermore, by leveraging established peptide MAM, we efficiently monitor critical quality attributes (CQAs) across a variety of sample sets analyzed through GMP compliant mass spectrometry. </font> </div> <div> <font> <br/> </font> </div> <div> <font color="#623e99"> <span> High-Throughput Intact Mass Screening </span> </font> </div> <div> <font> <b> <br/> </b> </font> </div> <div> <font color="#212b37"> With Data-Independent Acquisition (DIA) modes and advanced Waters Connect applications, the GMP-ready Xevo G3mass spectrometry system streamlines workflow to deliver comprehensive reports encompassing basic mass verification, high-throughput intact mass screening, and impurity profiling—all from a single injection. </font> </div> <div> <font> <b> <br/> </b> </font> </div> <div> <font color="#623e99"> <span> Data integrity with GMP-compliant software and automated calibration </span> </font> </div> <div> <font color="#623e99"> <span> <br/> </span> </font> </div> <div> <font color="#212b37"> Backed by our expertise, we navigate the complexities of biopharmaceutical analysis with finesse. Our commitment to achieving the highest levels of quality and data integrity is unwavering, upheld by GMP-compliant software and automated routine calibration. Every aspect, from instrument validation to creating reports, is meticulously conducted to fulfill regulatory requirements and adhere to industry standards for conducting comprehensive GMP mass spectrometry, paving the way for setting new analytical benchmarks in biologics development across all phases. </font> </div> </div> </div> </div> <div> <img src="https://irp.cdn-website.com/06bda01f/dms3rep/multi/blog+insert+images+into+text.png" alt=""/> </div> Wed, 05 Jun 2024 15:15:15 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/gmp-capabilities-in-mass-spectrometry-with-the-waters-xevo-g3-qtof English thumbnail main image https://www.biodextris.com/qbd-impact-on-biologics-development Discover how Quality by Design (QbD) helps streamline biologics development, reduce costs, and improve product outcomes in complex CDMO environments. <div data-rss-type="text"> <span>   </span> In the realm of complex biologics development, the integration of Quality by Design (QbD) not only assures product quality but also emerges as a powerful driver for cost reduction and accelerated timelines. A systematic approach to development in biopharma, it emphasizes the integration of quality evaluation at every step, ensuring the production of safer and more effective drugs while optimizing resources. Unlike traditional post-production testing, Quality by Design proactively identifies and adjusts critical parameters and factors involved in development. <div> This brief discussion explores the pivotal role of QbD in achieving these dual objectives. </div> <div> <br/> </div> <div> <b> <font> <span> <font> Determining quality target product profile and critical quality attribute is a key to a successful and efficient development. </font> </span> </font> </b> </div> <div> <b> <font> <br/> </font> </b> </div> <div> <font> It is important to define quality target product profile (QTPP) and critical quality attributes (CQA) of the product as soon as possible during the development stage. If well defined, the Quality by Design approach will help address issues early in the product development process and prevent failures than will lead to additional cost and delay during advanced stages of the project.      </font> </div> <div> <font> At Biodextris, we encourage and guide our client through Quality by Design process to ensure quality, cost optimization and timeline efficiency. </font> </div> <div> <font> <br/> </font> </div> <div> <font> <b> <span> Efficiency through Attribute Optimization and precise process control: </span> </b> </font> </div> <div> <font> <b> <br/> </b> </font> </div> <div> <font> <b> <span> Quality by Design enables a targeted optimization of critical product quality attributes, streamlining development efforts and reducing the need for extensive trial and error. By enhancing process understanding and control, QbD minimizes variations and deviations in complex biologics production. This precision and efficiency not only ensure consistent product quality but also accelerates the development timeline by avoiding delays associated with troubleshooting and rework.  </span> </b> </font> </div> <div> <font> <b> <br/> </b> </font> </div> <div> <font> <b> <span> Risk Mitigation for Cost-Efficient Development: </span> </b> </font> </div> <div> <font> <b> <span> <br/> </span> </b> </font> </div> <div> <font> <b> <span> Quality by Design systematically identifies and mitigates risks early in the development process. This proactive risk management not only safeguards against potential setbacks but also contributes to cost efficiency by preventing the need for costly corrections later in the development cycle. </span> </b> </font> </div> <div> <font> <b> <span> <br/> </span> </b> </font> </div> <div> <font> <b> <span> <font> Regulatory Compliance for Timely Approvals and Adaptability for Faster Life Cycle Management </font> </span> </b> </font> </div> <div> <font> <b> <br/> </b> </font> </div> <div> <font> Well defined QbD attributes aligns with regulatory expectations, ensuring that the development process is well-documented and compliant. This adherence expedites regulatory approvals, reducing the time and resources required for navigating the approval process. Furthermore, Quality by Design's emphasis on continuous improvement allows for swift adaptation to changes throughout the product's life cycle. This adaptability reduces the time and costs associated with implementing updates or modifications post-launch. </font> </div> <div> <font> <br/> </font> </div> <div> <font> For Biodextris, Quality by Design is not only a quality assurance framework but also a strategic ally for reducing costs and accelerating timelines in the development of complex biologics as well as decrease regulatory compliance risks by building product knowledge and understanding. Its systematic approach, from attribute optimization to risk mitigation and formulation efficiency, positions QbD as an indispensable tool for achieving cost-effective and timely success in the competitive landscape of all biologic products development, especially for Complex Biologics. </font> </div> <div> <font> <br/> </font> </div> <div> <font> <i> Contact us to see how Biodextris and Quality by Design can help you bring your innovation to life and follow our next newsletters for more details the QbD tools we use to improve your projects. </i> </font> </div> <div> <font> <b> <br/> </b> </font> </div> </div> Fri, 16 Feb 2024 14:11:16 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/qbd-impact-on-biologics-development English thumbnail main image https://www.biodextris.com/a-project-based-approach-to-biologics-cdmo-collaboration Explore how a project-based CDMO collaboration model ensures better flexibility, transparency, and outcomes in biologics development. <div data-rss-type="text"> In the landscape of the biopharmaceutical industry, the partnership between a biopharma sponsor and its biologics Contract Development and Manufacturing Organization (biologics CDMO) has become more than a simple business arrangement and <b> has transformed into a strategic collaboration characterized by flexibility and adaptability. </b> Historically, biopharma companies have had to contract very large projects out to biologics CDMO meaning they would commit large financial and organisational resources, which did not always match investment cycles. Today, the industry and its biopharma CDMOs are recognizing the benefits of <b> segmenting projects and costs, </b> aligning them with funding phases and thus optimizing resources while fostering innovation. <div> <br/> <div> </div> <span> <div> </div> </span> <span> <font> <span> <div> Biodextris: at the heart of a multi-expertise CDMO organization </div> <div> <br/> </div> <div> </div> </span> <div> </div> </font> </span> <div> With extensive development and manufacturing capacities, biologics CDMO Biodextris has accompanied this change with <b> strong, project-based partnerships </b> with the biopharma industry. As part of the <a href="https://www.clean-biologics.com/" target="_blank"> Clean Biologics group </a> , Biodextris is also at the heart of a multi-expertise organization, thus <b> enhancing the capacity to coordinate overall biopharma CDMO capacities </b> while keeping a segmented approach. </div> <div> <br/> </div> <div> <span> <font> <span> Aligning organisational resources with funding cycles to mitigate risk and foster innovation </span> </font> </span> </div> <div> <span> <font> <span> <br/> </span> </font> </span> </div> <div> Biopharma projects typically go through several funding cycles, covering discovery and R&amp;D, clinical trials and commercialization, and which require support from biopharma CDMOs and CROs. This includes sometimes long analytical, development and biomanufacturing phases requiring a sizable financial commitment. A flexible approach to biologics CDMO collaboration <b> aligns costs with these funding phases </b> ensuring that financial resources are used efficiently. </div> <div> <br/> </div> <div> Additionally, this strategy contributes to overall risk mitigation: the development cycle of a biopharma substance is rife with uncertainties, including regulatory changes, market dynamics, and technical advancements. Flexibility in biologics CDMO partnerships allows <b> biopharma companies to adapt to these pitfalls and hurdles more efficiently. </b> </div> <div> <br/> </div> <div> With a keen understanding of the biopharma dynamics and its <b> privileged position within a biologics CDMO group, </b> Biodextris optimizes resources for sponsors by reducing organisational burdens: this leaves <b> our partners with more time and resources for their core and strategic activities </b> including discovery, R&amp;D and business development. </div> <div> <br/> </div> <div> <br/> </div> </div> </div> Tue, 24 Oct 2023 12:44:32 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/a-project-based-approach-to-biologics-cdmo-collaboration English thumbnail main image https://www.biodextris.com/calder-biodextris-rsv-vaccine-phase1 Biodextris and Calder Biosciences partner for a Phase 1 RSV vaccine trial. Read how this collaboration accelerates vaccine innovation. <div data-rss-type="text"> <p> <span> <span> Boston, MA, June 5, 2023 (GLOBE NEWSWIRE) – Calder Biosciences Inc., a molecular engineering and clinical manufacturing-stage biotechnology company pioneering its 3D-Vaxlockä platform technology to engineer and develop novel protein subunit vaccines, today announced a clinical supply agreement with Biodextris Inc. </span> </span> </p> <p> <span>   </span> </p> <p> <span> Under the agreement, Calder Biosciences will evaluate DT-preF, its lead candidate in the development of a vaccine to prevent acute lower respiratory infections caused by the Respiratory Syncytial Virus (RSV), as part of a Phase I clinical trial that will include an efficacy read-out. Preclinical studies are designed to assess the toxicity and tolerability of the lead candidate vaccine. The preclinical study will begin in Nov and the Phase 1 clinical study will begin in H1 2024. </span> </p> <p> <span>   </span> </p> <p> <span> Calder Biosciences’ CEO, Chris Marshall, remarks: “We are truly excited to be working with the Biodextris team to bring our RSV vaccine candidate into production, featuring our novel manufacturing process. This represents the first of a series of conformationally locked protein subunit vaccines with greatly improved safety and potency.” </span> </p> <p> <span>   </span> </p> <h4> <span> "We are delighted to have signed this agreement with Calder Biosciences. It represents an important contract for Biodextris, as this work will be the first to be carried out by our production and development teams in our new industrial-scale vaccine and biologics development, manufacturing and packaging plant (CDMO)” says Alain Carrier, General Manager of Biodextris. The new Biodextris biomanufacturing centre (cGMP) and its analytical capabilities was developed with the support of the governments of Quebec and Canada and Investissement Québec. </span> </h4> <p> <span>   </span> </p> <p> <span> Today's announcement was made at the 2023 BIO International Convention, which is being held in Boston, MA, from June 5 to 8.   </span> </p> <p> <span>   </span> </p> <h3> <span> About Biodextris Inc. </span> </h3> <p> <span> <span> Founded in 2015, </span> </span> <a href="https://biodextris.com/" target="_blank"> Biodextris </a> <span> <span>  is a subsidiary of Clean Biologics SAS, which provides clinical manufacturing process analysis and development services and quality control testing for clients in the vaccine and biologics industries. The company is staffed by experienced biologics development scientists, and key team members have worked together in medium and large vaccine development and manufacturing companies for almost twenty years. The Biodextris team provides its extensive pharmaceutical company expertise in a more personal and interactive setting to clients of various sizes. The company develops, manufactures, and tests a wide range of biological products for vaccine, pharmaceutical, and other applications. Biodextris has the experience and expertise to develop high-quality, robust, and marketable products, while acting with the flexibility and sense of urgency required by small organizations. </span> </span> </p> <p> <span>   </span> </p> <h3> <span> About Calder Biosciences Inc. </span> </h3> <p> <span> Founded in 2018, Calder Biosciences is a New York City-based, privately held, clinical manufacturing-stage biotechnology company with financial backing from SOSV, a global venture capital firm. Calder is developing next-generation protein subunit vaccines. Calder’s proprietary 3D-Vaxlockä technology locks proteins in the conformation that most prominently exposes sites of vulnerability and elicits substantially amplified and focused, neutralizing antibody responses, along with strong T cell responses. These responses are expected to improve both protection and safety. Better stability also substantially reduces cold chain requirements and spoilage. Calder’s lead, 3D-Vaxlock’d RSV vaccine is entering clinical development. </span> </p> <p> <span>   </span> </p> <p> <span> For more information: </span> </p> <p> <span> www.calderbiosciences.com </span> </p> <p> <a href="http://www.biodextris.com/" target="_blank"> www.biodextris.com </a> <span> <span> </span> </span> </p> </div> Tue, 06 Jun 2023 16:48:06 GMT https://www.biodextris.com/calder-biodextris-rsv-vaccine-phase1 English thumbnail main image https://www.biodextris.com/biodextris-commissions-a-custom-designed-cgmp-biomanufacturing-and-analytical-facility Biodextris launches a new cGMP facility designed for advanced biomanufacturing and analytical services. See what this means for your next project. <div data-rss-type="text"> <p> <span> We are proud to announce that Biodextris has </span> <span>  commissioned a dedicated 30,000 sq.ft. custom-designed cGMP biomanufacturing facility including development and analytical capabilities </span> <span>  to cater to growing demands. The bioprocessing building includes: </span> </p> <p> <br/> </p> <ul> <li> <span> 6,000 sq.ft. segregated  </span> <span> cGMP biomanufacturing suites </span> </li> <li> <span> 2,500 sq.ft. controlled material warehousing </span> </li> <li> <span> 8,000 sq.ft. process development and analytical / QC laboratories </span> </li> </ul> <p> <br/> </p> <p> <span> Biodextris is well known for its agility and the increase in available cGMP bioproduction suites will allow us to continue to adapt to our growing customer needs. Our production capacity will be expanded  </span> <span> by the addition of 200L bioreactors as well as aseptic filling capacity </span> <span> . </span> </p> <p> <br/> </p> <p> <span> The new analytical/QC laboratory will benefit from the addition of new equipment to support the increasing number of techniques performed internally as well as to ensure that the latest technologies are available to Biodextris clients. </span> </p> <p> <br/> </p> <p> <span> This investment in cGMP biomanufacturing infrastructure and analytical capabilities is a key element of our strategy. It supports our mission as a CDMO to  </span> <span> bring innovation to life </span> <span> , by offering our partners and client a facility capable of carrying their projects from early clinical phases to commercial production. This extension of capabilities is also an integral part of the strategy of the Clean Biologics group to propose integrated CDMO services for biopharma sponsors. </span> </p> <p> <br/> </p> <p> <span> The newly constructed analytical laboratories and cGMP bioprocessing facility is located in the Cité de la Biotech Laval and is set to be  </span> <span> ready for operation during the summer of 2023. </span> </p> <p> <span> <br/> </span> <span> Please  </span> <a href="/contact-us"> reach out to the team </a> <span>  for additional information. </span> </p> </div> Wed, 14 Sep 2022 11:22:47 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/biodextris-commissions-a-custom-designed-cgmp-biomanufacturing-and-analytical-facility English thumbnail main image https://www.biodextris.com/is-cell-culture-to-replace-microbial-fermentation Explore whether cell culture is replacing microbial fermentation in biologics manufacturing—and what this shift means for CDMO strategy and innovation. <div data-rss-type="text"> <h2> <span> Is cell culture to replace microbial fermentation in the biologics arena ? </span> </h2> </div> <div data-rss-type="text"> <p> <span> <span> This question is certainly a common one for those looking at the industry overall and trying to decide where they want to invest their efforts. Traditionally microbial fermentation operations had been focused on the food and beverage industry starting centuries ago, and over the past couple of decades </span> </span> <span> the method of production evolved into a biologics production vehicle </span> <span> , with the advent of new technologies to manipulate genes, we have started to find new use for microbial fermentation. </span> </p> </div> <div data-rss-type="text"> <h3> <span> Why microbial fermentation for biologics production continues to grow </span> </h3> </div> <div data-rss-type="text"> <p> <span> <span> The use of microbial fermentation in the production of pharmaceuticals includes various therapeutic peptides, insulin, vaccines and even cancer therapeutics[1] which is one of the areas of much attention in late! This method presents a lot of advantages in that production can happen over a short period of time, microbes are robust and as such can be </span> </span> <span> cultured in a high density producing high yields of the target </span> <span> . At the same time microbial fermentation also has its limits, and generally speaking, this has to do with the complexity of the target molecule. As you start into more complex molecules like monoclonal antibodies, antibody fragments, larger antigens, antibody-drug conjugates, the requirements to produce the molecule in its useful conformation (ie. Folded and structured to be useful) cannot be addressed by microbial fermentation and then must be tackled with cell culture. <br/> <br/> Though cell culture is a lot more challenging to carry out, requires more time and takes significantly more resources as the yields are lower, the complexity of the cells themselves offer up the capability of the necessary post translation modifications to produce the target. <br/> </span> </p> </div> <div data-rss-type="text"> <h3> <span> Biodextris continues to offer its expertise in microbial fermentation as this market evolves </span> </h3> </div> <div data-rss-type="text"> <p> <span> <span> At Biodextris we originally started exclusively in the arena of microbial fermentation as a vehicle but over the past few years we recognized the ever growing arena of complex biologics and have adapted by outfitting our facilities with GMP cell culture production infrastructure to address our clients in both arenas, microbial fermentation and cell culture alike. Considering recent data would indicate that Europe and North America will capture more than 80 percent of </span> </span> <span> the estimated $9.3 billion dollar microbial fermentation market by 2030 </span> <span> , it’s no wonder there is no immediate plans to discontinue these services. </span> </p> </div> <div data-rss-type="text"> <p> <span> [1]  </span> <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3026423/" target="_blank"> Bioeng Bugs. </a> <span>  2010 May-Jun; 1(3): 178–190. <br/> Published online 2009 Dec 2. doi:  </span> <a href="https://dx.doi.org/10.4161%2Fbbug.1.3.10903" target="_blank"> 10.4161/bbug.1.3.10903 </a> <span> <br/> </span> <span> P </span> <span> MCID: PMC3026423 PMID:  </span> <a href="https://www.ncbi.nlm.nih.gov/pubmed/21326924" target="_blank"> 21326924 </a> <span>  Microbial-based therapy of cancer <br/> Current progress and future prospects  </span> <a href="https://www.ncbi.nlm.nih.gov/pubmed/?term=Bernardes%20N%5BAuthor%5D&amp;cauthor=true&amp;cauthor_uid=21326924" target="_blank"> Nuno Bernardes </a> <span> ,1  </span> <a href="https://www.ncbi.nlm.nih.gov/pubmed/?term=Seruca%20R%5BAuthor%5D&amp;cauthor=true&amp;cauthor_uid=21326924" target="_blank"> Raquel Seruca </a> <span> ,2  </span> <a href="https://www.ncbi.nlm.nih.gov/pubmed/?term=Chakrabarty%20AM%5BAuthor%5D&amp;cauthor=true&amp;cauthor_uid=21326924" target="_blank"> Ananda M Chakrabarty </a> <span> ,3 and  </span> <a href="https://www.ncbi.nlm.nih.gov/pubmed/?term=Fialho%20AM%5BAuthor%5D&amp;cauthor=true&amp;cauthor_uid=21326924" target="_blank"> Arsenio M Fialho </a> <span> 1 </span> </p> <p> <span> [2] https://www.europeanpharmaceuticalreview.com/news/133660/microbial-contract-biomanufacturing-market-to-be-worth-9-3-billion-by-2030/ <span>  </span> </span> </p> </div> Fri, 13 May 2022 11:32:29 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/is-cell-culture-to-replace-microbial-fermentation English thumbnail main image https://www.biodextris.com/why-is-process-development-such-a-lengthy-activity Why is process development so complex and time-consuming in biologics? Get insights into key challenges and solutions for accelerating timelines. <div data-rss-type="text"> <h2> <span> Why is Process Development such a lengthy activity? </span> </h2> </div> <div data-rss-type="text"> <p> <span> Process development is a critical and lengthy activity </span> <span> , which holds a key place within discovery, development and manufacturing phases. </span> </p> <p> <span> <br/> </span> </p> <p> <span> <span> Many clients reckon drug discovery is the lengthiest considering its pivotal and demanding aspects: they indeed go through a gruelling process to find their target molecule and then the next challenge is to </span> </span> <span> get a genetically modified organism to express (produce) the molecule </span> <span> <span> in some appreciable amount, also ensuring generations of cells continue this expression. This part of the drug discovery process typically takes the longest time and often resides in academic organizations and Contract Research Organizations (CROs). </span> </span> </p> <p> <span> <br/> </span> </p> <p> <span> <span> A popular misconception is that the next steps of process development, analytical development and preclinical manufacturing is a predictable and rapid process, however, this is not the case. </span> </span> <a href="/development-services"> Process Development </a> <span> <span> remains a lengthy activity at both Upstream and Downstream steps, and here are a few reasons why. <br/> </span> </span> </p> </div> <div data-rss-type="text"> <h3> <span> Upstream Process Development considerations </span> </h3> </div> <div data-rss-type="text"> <p> <span> <span> For the first step of development, before any Upstream Process development (USP development) is even commenced, the structure and function of the molecule (most typically protein based) must be considered. </span> </span> <span> USP conditions will need to be conducive </span> <span> <span> to get the cells to produce their required target molecule, but there has to be assurances that where the molecule is produced won’t be affected negatively by its environment. </span> </span> </p> <p> <span> <br/> </span> </p> <p> <span> In the early development process, it would likely be well known where the target molecule resides, either inside the cell, in the membrane, inside inclusion bodies or expressed outside the cell. This information coupled with structure and functional details will dictate both growth and harvest parameters. Failure to properly address these factors will potentially result in aggregation or undesired modifications along the way of Upstream Processing, which could make Downstream Processing (DSP) impossible or alternatively render the target molecule inactive or with a reduced potency. </span> </p> <p> <span> <br/> </span> </p> <p> <span> <span> For the reasons above, there is a </span> </span> <span> careful process of selecting proper growth mediums, agitation methods, key temperature controls and the right blend of required gasses </span> <span> . Couple these with timing and induction methods (techniques and products used to trigger cells into production), there are a great deal of variables to orchestrate to get your optimal expression, resulting in long periods of time where Upstream Process Development has to be perfected. <br/> </span> </p> </div> <div data-rss-type="text"> <h3> <span> Downstream Process Development considerations </span> </h3> </div> <div data-rss-type="text"> <p> <span> <span> On the Downstream Process Development side, the team needs to prepare based on factors mentioned above and ensure that </span> </span> <span> the process follows a logical flow and amenable conditions to ensure the maintenance of the critical quality attributes </span> <span> <span> of the protein of interest. The removal of process and host cell -related impurities and the scalability of the developed process must also be considered. Standard DSP development phases include multiple </span> </span> <span> chromatography steps, viral clearance steps, tangential flow filtration and a final sterile filtration </span> <span> <span> step. Centrifugation and dialysis are generally avoided as they are not scalable and cannot support CMC requirements for Phase III and beyond. Various chromatography techniques and resins per technique exists and a high throughput screening is required to select the optimal combination of resins and chromatography conditions. Viral clearance inactivation and filtration are also a core in the purification process of a recombinant protein. </span> </span> </p> <p> <br/> </p> <p> As the use of detergent and solvents are commonly used for the inactivation and use of additives are used for the filtration, one should consider <span> <span> the impact of this process step on the </span> </span> <a href="/analytical-services"> analytical method </a> <span> <span> panel </span> </span> as any additional reagent used during the process should be tested for its residuals. </p> </div> <div data-rss-type="text"> <h3> <span> Top experts to help you anticipate lengthy development steps and reduce timeline </span> </h3> </div> <div data-rss-type="text"> <p> <span> <span> Biodextris, an experienced CDMO with extensive GMP track-record, has helped dozens of sponsors achieve their process development targets through reliable steps and proven processes leading to facilitated </span> </span> <a href="/bioproduction-services"> biomanufacturing </a> <span> <span> </span> </span> <span> phases. </span> </p> <p> <br/> </p> <p> Our top experts at Biodextris have worked on dozens of biological products and have used this experience to streamline the lengthy steps of Process Development by anticipating potential bottlenecks and typical issues. </p> <p> <br/> </p> <p> Please <a href="/contact-us"> re <span>  </span> ach out </a> to our team to discuss process development specifications and start optimizing your general timeline! </p> </div> Fri, 18 Mar 2022 11:43:57 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/why-is-process-development-such-a-lengthy-activity English thumbnail main image https://www.biodextris.com/oragenics-biodextris-mucosal-covid19 Biodextris and Oragenics partner to evaluate a mucosal adjuvant for intranasal COVID-19 vaccines. Read more about this collaborative step. <div data-rss-type="text"> <p> <span> TAMPA, Fla.–(BUSINESS WIRE)– </span> <span> Oragenics, Inc. (NYSE American: OGEN) </span> <span> <span> (“Oragenics” or the “Company”) announced it has entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants in the Company’s Terra CoV-2 vaccine against COVID-19. Adjuvants are added to vaccines to enhance their immunogenicity. BDX100, BDX300 and BDX301 are proteosome-based adjuvants comprised of proteins and lipopolysaccharides with improved attributes including enhanced immune response, manufacturing efficiency and the benefits of intranasal vaccine administration. </span> </span> </p> </div> <div data-rss-type="text"> <p> <span> “This material transfer agreement both expands and advances the development of our Terra CoV-2 vaccine with a novel delivery option” </span> </p> <p> <a href="https://www.businesswire.com/news/home/20210309005395/en/Oragenics-Enters-into-Material-Transfer-Agreement-with-Biodextris-for-Mucosal-Adjuvant-for-Intranasal-COVID-19-Vaccine#" target="_blank"> Tweet this </a> <span> <br/> </span> </p> </div> <div data-rss-type="text"> <p> <span> The initial agreement calls for the three intranasal adjuvants to be used in combination with the Oragenics’ antigen vaccine candidate as part of the preclinical immunological evaluation of Terra CoV-2, for the prevention of coronavirus disease caused by infection with SARS-CoV-2 virus. The information generated from the studies employing the new intranasal vaccine candidate would potentially support the U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) application and an application to Health Canada to initiate clinical trials. The agreement allows for the future collaboration regarding the intranasal delivery of vaccine during clinical development with the opportunity to enter into a commercial agreement upon regulatory approval of the intranasal vaccine. </span> </p> <p> <span> <br/> </span> </p> <p> <span> The Terra CoV-2 vaccine plus Biodextris’ intranasal mucosal adjuvants will be studied in the preclinical animal studies, including hamster viral challenge studies, mouse immunogenicity studies and the rodent toxicology study required for regulatory approval prior to the initiation human testing. </span> </p> <p> <span> <br/> </span> </p> <p> <span> “This material transfer agreement both expands and advances the development of our Terra CoV-2 vaccine with a novel delivery option,” said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics. “The Biodextris intranasal mucosal adjuvants in combination with the Oragenics antigen open up new possibilities for a vaccine that could potentially be a more effective and convenient option than those currently available. Given the benefits of intranasal administration along with Terra CoV-2’s other advantages, including the potential to be stored and distributed at refrigerated temperatures, we believe there is significant opportunity to help address the worldwide COVID-19 pandemic, particularly in the post-near-term immunization phase where booster shots and potential effectiveness against a variety of COVID-19 variant strains may continue to be required.” </span> </p> <p> <span> <br/> </span> </p> <p> <span> Joseph Zimmerman, President of Biodextris, added, “We are delighted to partner with Oragenics on exploring the potential of their Terra CoV-2 vaccine. Our proteosome-based compounds can be powerful adjuvants and offer several advantages, including the ability to elicit both mucosal and serum antibodies while offering innate and adaptive immunity.” </span> </p> <p> <span> <br/> </span> </p> <p> <span> About Terra CoV-2 </span> </p> <p> <span> In March 2020, Oragenics acquired a non-exclusive license from the National Institutes of Health (“NIH”) for its stabilized prefusion Terra CoV-2 spike protein. Oragenics announced that its spike protein had been successfully inserted into Chinese Hamster Ovary (“CHO”) cells production and analytical development are underway. CHO cells are used to produce a number of FDA-approved recombinant proteins. </span> </p> <p> <span> <br/> </span> </p> <p> <span> About Biodextris Inc. </span> </p> <p> <span> Based in Laval, Québec, Biodextris is a contract research organization providing a suite of analytical, process development and CMC consulting services for vaccines and biologics in the clinical stages of development. The company’s expertise, facilities and quality systems support clients to confidently navigate a path from R&amp;D to early-phase clinical trials. For more information, visit:  </span> <a href="/"> www.biodextris.com </a> <span> . </span> </p> <p> <span> <br/> </span> </p> <p> <span> About Oragenics, Inc. </span> </p> <p> <span> Oragenics, Inc. is focused on the creation of the Terra CoV-2 vaccine candidate to combat the novel coronavirus pandemic and the further development of effective treatments for novel antibiotics against infectious diseases. The Company is dedicated to the development and commercialization of a vaccine candidate providing specific immunity from novel coronavirus. The Terra CoV-2 immunization leverages coronavirus spike protein research conducted by the National Institutes of Health. In addition, Oragenics has an exclusive worldwide channel collaboration with Eleszto Genetika, Inc. relating to the development of novel lantibiotics. </span> </p> <p> <span> <span> <br/> For more information about Oragenics, please visit </span> </span> <a href="http://www.oragenics.com" target="_blank"> www.oragenics.com </a> <span> . <br/> </span> </p> <p> <span> <br/> </span> </p> <p> <span> Forward-Looking Statements </span> </p> <p> <span> This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, the following: the Company’s ability to advance the development of Terra CoV-2 under the timelines and in accord with the milestones it projects including in potential combination with a nasal mucosal adjuvant; the Company’s ability to obtain funding, non-dilutive or otherwise, for the development of Noachis Terra’s Terra CoV-2 vaccine and adjuvant products, whether through its own cash on hand, or another alternative source; the regulatory application process, research and development stages, and future clinical data and analysis relating to Terra CoV-2, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the potential application of Terra CoV-2 to other coronaviruses; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to COVID-19 immunization and therapeutic treatments, and demand for vaccines including adjuvants; the Company’s expectations as to storage, administration and distribution, potential market and impact of other vaccines being administered; other potential adverse impacts due to the global COVID-19 pandemic, such as delays in regulatory review, interruptions to manufacturers and supply chains, adverse impacts on healthcare systems and disruption of the global economy; and general economic and market conditions risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law. <br/> </span> </p> </div> Wed, 09 Mar 2022 12:28:47 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/oragenics-biodextris-mucosal-covid19 thumbnail main image https://www.biodextris.com/the-importance-of-technical-oversight-cmc-in-drug-development Why does CMC oversight matter in drug development? Learn how strong technical governance supports faster timelines and regulatory success. <div data-rss-type="text"> <p> <span> <span> The area of drug development is a veritable minefield with many junctures where a project can come to an abrupt end. The early discovery period presents its own significant challenges, but once a client has selected their lead candidate many organizations feel the heavy lifting is over, however this simply isn’t the case. The next steps of plotting out a </span> </span> <a href="/bioproduction-services"> clinical manufacturing process </a> <span> <span> paired with </span> </span> <a href="https://clean-cells.com/activities/quality-control-testing/biosafety-testing-clean-cells/" target="_blank"> analytics to characterize the product </a> <span> , and the inherent regulatory considerations are a very involved and complicated process. </span> </p> </div> <div data-rss-type="text"> <h2> <span> The CMC SME : a key role to acceptance and patient safety </span> </h2> </div> <div data-rss-type="text"> <p> <span> Enter the Chemistry, Manufacturing and Controls Subject Matter Expert (CMC SME) for the purpose of technical oversight. The direction of the CMC program will vary, but generally either an expert is hired-on full time as a staff member, contracted as a consultant, or in some cases an additional service provided by some CDMOs (contract development and manufacturing organization). In any case, the expertise the CMC SME brings to the table is the practical experience of navigating through government regulatory bodies (like FDA or Health Canada) ensuring that the program is well positioned for acceptance, and that patient safety is considered at every step leading to GMP manufacturing. This process may sound simple but there is a plethora of variables to consider from the practicality of scale-up and processing technologies to the overall costs predicted at the end of the process. While balancing these considerations as part of technical oversight, the CMC SME also has to operate within an assigned budget for all these activities and on a timeline that is reasonable for the company. </span> </p> <p> <br/> </p> <p> <span> Terrence Cochrane, President of BrevisRefero Corporation (a Canadian biologics CMC consultancy) shares some of his experiences over the past 22 years to further illustrate the importance of having expert guidance and technical oversight: </span> </p> <p> <br/> </p> <p> <span> “It can be challenging when there is the realization of a CMC experience gap within the organization, which can result in directional program changes once a CMC SME joins after activities have already started. As a result, the client has spent time, money and resources on activities that may require partial or full redirection, but it also affects the CDMO they’re engage with, in that the repeat (or start-over) of work can cause significant delays in moving the client’s product into GMP manufacturing. What I typically recommend to early-stage companies moving their product into clinical development is to perform an inventory of the technical CMC capabilities of the organization, such as process or analytical development experience, or scale-up and GMP manufacturing track-record. From there, management can evaluate the organizational skillset in comparison to the demands of the CMC program to determine whether the existing organization could possibly be augmented by an external CMC SME. While the thought of engaging an external SME can seem like a daunting task, the reality is that CMC SME’s (such as those at BrevisRefero) are used to being thrown into a fast-paced and dynamic CMC environment with many internal stakeholders, and they can typically come up to speed quickly for the benefit of both the client and drug development program. At the end of the day, speed to first-in-human studies is a top priority, and neglecting the important aspect of CMC experience can cause significant delays or even failure. In one recent project I observed a 9-month delay due to having to start over in critical areas of the CMC program, and in another program from a couple years ago a 6-month delay. This can cause real harm to the timelines while the technical program is sorted out, not to mention the inevitable shaking of board of director and investor confidence in the organizations’ ability to deliver.” </span> <span> <br/> </span> </p> </div> <div data-rss-type="text"> <h3> <span> How technical oversight and CMC complements CDMO services: </span> </h3> </div> <div data-rss-type="text"> <p> <span> <span> Time and money are the two most critical factors in any business’ success and as illustrated above, expert guidance in drug development will yield a return on investment by saving both. Of course, complementary to expert guidance and technical oversight, a comprehensive service provider like the Clean Biologics family of companies is also imperative to support product development for a successful drug launch. The Clean Biologics family collectively offers </span> </span> <a href="https://clean-cells.com/activities/quality-control-testing/biosafety-testing-clean-cells/" target="_blank"> quality control, biological safety tests for biopharmaceutical products for regulatory compliance </a> <span> <span> , </span> </span> <a href="https://clean-cells.com/activities/manufacturing/eukaryotic-cell-bank-clean-cells/" target="_blank"> production of cell banks /GMP-grade BSL2/BSL3 virus seed stock </a> <span> <span> ; also offering CDMO services in both GMP and non-GMP </span> </span> <a href="/bioproduction-services"> with both microbial </a> <span> <span> , </span> </span> <a href="/bioproduction-services"> viral and cell-based platforms </a> <span> <span> along with the full complement of GMP analytical testing and development in the areas of vaccine, antibodies, oncolytic viruses and viral vectors. </span> </span> </p> </div> <div data-rss-type="text"> <p> <span> Editorial by John Mukherjee – </span> <span> <span> Director of Business Development and Marketing at </span> </span> <a href="/"> Biodextris Inc </a> <span> <span> . Terrance Cochrane can be reached at </span> </span> <a href="mailto:t.c@brevisrefero.com"> t.c@brevisrefero.com </a> <span> ; BrevisRefero Corp. is a consultancy offering a comprehensive suite of CMC related services. </span> </p> </div> Mon, 28 Feb 2022 11:49:08 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/the-importance-of-technical-oversight-cmc-in-drug-development English thumbnail main image https://www.biodextris.com/how-the-pandemic-supercharged-biodextris-business Learn how the pandemic accelerated Biodextris’ growth and expanded our role in vaccine development, manufacturing, and global biotech partnerships. <div data-rss-type="text"> <p> <span> The COVID-19 pandemic prompted an unprecedented influx of vaccine and therapeutic projects for Canadian biotech companies — and Biodextris is rising to the challenge. </span> </p> <p> <br/> </p> <p> When pharmaceutical giant GSK restructured their Vaccine development to Belgium in 2015, the doors to its Laval location was destined to close. Many of the researchers and staff at its former Canadian branch faced uncertain futures — until three former employees struck a deal with GSK and founded <a href="/"> Biodex <span>  </span> tris </a> . </p> <p> <br/> </p> <p> Based in Laval, QC, Biodextris specializes in process and analytical development and bio-production of various biologics. Some are destined directly for clinical trial while others are parts of a bigger product. </p> </div> <div data-rss-type="text"> <h2> <span> Diverse teams and diverse industries </span> </h2> </div> <div data-rss-type="text"> <p> <a href="/"> Biodextris </a> <span> <span> was founded under the leadership of Dr. Joseph Zimmermann, now President and CEO, and Co-Founders Christine Jacques and Paul Rice. The founders retained the top scientists, researchers, and staff from the GSK closure and have since grown the team and gained recognition as a skilled biologics CDMO (contract development and manufacturing organization) despite its founding only five years ago. </span> </span> </p> <p> <br/> </p> <p> <span> Experienced in addressing the necessary steps between early-stage research and large-scale production, Biodextris services a wide range of industries, from diagnostics to veterinary and medical sciences. And with the support of stakeholders from government, academia, and the private sector, they’re executing several COVID-19 vaccine and therapeutic projects. <br/> </span> </p> </div> <div data-rss-type="text"> <h2> <span> Preparing for the future </span> </h2> </div> <div data-rss-type="text"> <p> <span> The burning question of the moment — “How fast can every Canadian receive a COVID-19 vaccine?” — depends on domestic production capabilities. Currently, Canada doesn’t have the capacity to manufacture biologics on a scale appropriate to vaccinate the nation’s population against COVID-19. While only smaller batches of a vaccine can be produced domestically, Canada’s health care system relies almost entirely on China, the U.S., and European countries for commercial production of biologics. </span> </p> <p> <br/> </p> <p> Even the federal government has acknowledged that such resources will be critical to both Canada’s long-term public health and the nation’s ability to compete in the global biotech sector. </p> <p> <br/> </p> <p> This is the logical next step for <a href="/"> Biodextris </a> . They had already begun assessing shortages in Canada’s biologics supply chain before the pandemic struck, and now, they’re focusing on how large-scale, domestic manufacturing can become a reality. </p> <p> <br/> </p> <p> The COVID-19 pandemic has humbled every country on the planet. In Canada, the need to establish and prepare our own resources for future crises has become apparent. Politics and protectionism could limit public access to necessary therapeutics, vaccines, and other essential items — doubly so if they’re produced outside the nation and require importation. Biodextris is determined to become a significant player as this long-term, national strategy evolves so that Canadians have quick and easy access to life-saving technologies. </p> <p> <br/> </p> <p> Source: <a href="https://www.innovatingcanada.ca/technology/how-the-pandemic-supercharged-biodextris-business/#" target="_blank"> In <span>  </span> novating Canada </a> </p> </div> Sun, 27 Feb 2022 11:52:25 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/how-the-pandemic-supercharged-biodextris-business English thumbnail main image https://www.biodextris.com/clean-biologics-acquires-biodextris The Project Coordinator uses scientific and professional knowledge/experience in accordance with regulatory requirements to lead projects from start to completion. <div data-rss-type="text"> <p> <span> “We are excited to join forces with the Clean Biologics group and we look forward to introducing our shared client base to the advantages of this alliance.” </span> </p> <p> <br/> </p> <p> <a href="https://www.ala.com/clean-biologics-sas-acquires-biodextris-inc/" target="_blank"> Re <span>  </span> ad the Press Release here </a> . </p> </div> Wed, 09 Jun 2021 11:54:57 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/clean-biologics-acquires-biodextris English thumbnail main image https://www.biodextris.com/biodextris-honored-by-biotech-city-covid19 Biodextris is recognized for its contributions to the fight against COVID-19 by Biotech City and the Canadian biotech community. <div data-rss-type="text"> <p> <span> The Biotech City is proud of the efforts of resident companies contributing to the fight against COVID-19: </span> </p> <p> <span> <br/> </span> </p> <p> <span> Nexelis has been granted reference laboratory status by the Bill and Melinda Gates foundation and is collaborating on candidate vaccines. <br/> Corealis Pharma Inc. has developed oral formulations for antivirals and manufactures clinical batches. <br/> Altasciences has completed a Phase I on gimsilumab in SARS-CoV-2 patients. <br/> Biodextris developing a nasal vaccine platform with preclinical activity. <br/> Roche Diagnostics provides instruments and tests to respond to the pandemic. <br/> Bausch Health donates drugs. <br/> CQIB incubator companies are also involved: <br/> Ovensa Inc. is working on siRNA to modulate viral infection and pulmonary fibrosis. <br/> Oligo Medic has adapted to the manufacture of disinfectant gel. <br/> Glycovax Pharma is working on a platform for viral adhesion inhibitors. <br/> IniXium conducts research on the replication of the virus. <br/> ILS Pharmaceutical performs compliance tests for the release of drugs and disinfectant products. </span> </p> <p> <span> <br/> </span> </p> <p> <span> View original post here: https://www.linkedin.com/posts/cit-de-la-biotech-biotech-city_the-biotech-city-is-proud-of-the-efforts-activity-6651540714033340416-IpzG/ <br/> </span> </p> </div> Thu, 09 Apr 2020 11:58:44 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/biodextris-honored-by-biotech-city-covid19 English thumbnail main image https://www.biodextris.com/biodextris-dans-biotech-finances Biodextris featured in Biotech Finances—highlighting innovation and growth in the biologics and vaccine development sector. <div data-rss-type="text"> <h2> <span> Biodextris cherche 1 à 3,5 M€ </span> </h2> </div> <div data-rss-type="text"> <p> <span> La CRO canadienne basée à Laval, lancée en septembre 2015 par Christine Jacques, Paul Rice et Joseph Zimmerman, entend profiter de sa future levée auprès d’investisseurs canadiens pour augmenter sa capacité de production, diminuer ses coûts d’opération par employé et bâtir une usine de fabrication de lots cliniques. Ex-chercheurs seniors de l’unité nord-américaine principale de GSK-Vaccins, les trois fondateurs ont profité de la fermeture du centre de recherche de cette big pharma à Laval, cédé par la suite à Néomed, pour s’émanciper et se lancer dans l’aventure entrepreneuriale. </span> </p> <p> <br/> </p> <p> Ils ont pu obtenir quelques aides remboursables, 173 k€ venant de la ville de Laval et de la Banque de développement du Canada, qui leur ont permis de démarrer dans les locaux mêmes du centre de recherche. « La situation était avantageuse pour nous, car nous disposions des équipements avec lesquels nous avions l’habitude de travailler chez notre précédent employeur », précise Christine Jacques, directrice des services analytiques chez Biodextris. « Nous étions immédiatement opérationnels, avec une excellente expertise et, très vite, nous avons décroché un client important à l’international dont nous ne pouvons divulguer le nom. Désormais, après un peu plus d’un an d’existence, il nous est nécessaire d’élargir le spectre de notre activité ». Concrètement, l’entreprise, qui a bouclé son premier exercice en engrangeant 690 k€ de chiffre d’affaires, est à la recherche d’un site pouvant accueillir une usine de production de lots cliniques de produits biologiques. Elle emploie d’ores et déjà dix salariés et pense en recruter six autres prochainement. « Les CRO basées au Canada qui offrent les services tels que les nôtres n’étant pas très nombreuses, nous y avons vu une opportunité de croissance », explique Christine Jacques à propos de sa montée en puissance rapide. </p> </div> <div data-rss-type="text"> <p> <span> “L’expérience GSK pour servir autant </span> </p> <p> <span> la grosse pharma que les petites biotech.” </span> <span> <br/> </span> </p> </div> <div data-rss-type="text"> <p> <span> L’expertise qui fait la différence </span> </p> <p> <span> Au Québec, Biodextris reste, semble-t-il, protégée en raison de son expertise. Les trois fondateurs ont en effet développé des douzaines de produits pour des essais cliniques en phases early à destination des marchés canadiens, états-uniens et européens. « Avec cette expérience héritée de GSK, nous savons ce qu’il faut pour amener un produit en phase clinique et comprenons très bien les situations, autant pour les big pharma que pour les petites biotech. Notre service consiste à accompagner et conseiller le client pour développer un procédé de fabrication robuste et fiable incluant la fermentation, la purification et la formulation, pas seulement à réaliser des tests », souligne Christine Jacques. La moitié des activités de la CRO est consacrée au contrôle qualité des produits biologiques durant toute la durée des études cliniques. La prochaine étape pour Biodextris consistera à percer le marché américain en priorité et à réagir aux opportunités qui se présenteront à l’international, notamment en Chine. Il faudra pour cela réussir le round de financement qui est en cours. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Opinion de Jean-Marc Juteau, directeur de la Cité de la Biotech (Québec) </span> </p> <p> <span> Il y a un an, alors que plusieurs chercheurs et entreprises présentaient leurs projets afin de démarrer une spin-off dans les anciens locaux de GSK et s’installer chez Néomed, l’équipe des fondateurs de Biodextris en avait déposé l’un des meilleurs. Plusieurs partenaires du développement économique, lors des réunions d’évaluation, ont immédiatement soulevé la qualité de sa candidature. Depuis octobre 2015, il s’agit définitivement de l’une des compagnies de ce lot qui a le mieux réussi. Les trois chercheurs-fondateurs ont pu collecter les aides financières nécessaires, des contrats avec des clients importants et à offrir un ensemble de services leur permettant d’aller chercher des revenus très intéressants sur le court terme. Les fondateurs sont très complémentaires, ayant des expertises indéniables en laboratoire ainsi que pour le développement des affaires. Avec leur vision commerciale, leur plan d’affaires clair, il ne fait aucun doute qu’ils trouveront les fonds nécessaires pour le financement de leur expansion ainsi que pour l’obtention de nouveaux contrats. </span> </p> <p> <span> <br/> </span> </p> <p> <span> 173 k€ </span> <span> <br/> C’est le montant obtenu par Biodextris sous forme de prêts de la ville de Laval et de la Banque de développement du Canada, pour son démarrage. La société, avec 690 k€ de chiffre d’affaires, cherche à lever 1 à 3,5 M€ pour son expansion. </span> </p> <p> <br/> </p> <p> <span> 73 Md€ </span> <span> <br/> C’est le montant du marché global, estimé pour 2019, du contrat pharmaceutique de la fabrication en sous-traitance, qui croît à un taux annuel moyen de 7,5 % depuis 2013, alors à 50 Md€. </span> </p> <p> <br/> </p> <p> <span> 75 % </span> <span> <br/> </span> <span> C’est le pourcentage des 600 cadres questionnés de compagnies pharmaceutiques et biotech cherchant à sous-traiter, et qui s’attendent à augmenter leurs dépenses en services contractuels recherche et fabrication au cours des cinq prochaines années, selon un sondage réalisé par Visiongain en février 2015. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Article publié dans Biotechfinances • Lundi 24 octobre 2016 • No 742 <br/> </span> </p> </div> Tue, 25 Oct 2016 12:04:08 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/biodextris-dans-biotech-finances English thumbnail main image https://www.biodextris.com/biodextris-keeps-team-together-to-provides-analytical-and-process-development-services Biodextris strengthens its capabilities by retaining its expert team to provide high-quality analytical and process development services. <div data-rss-type="text"> <p> <span> LAVAL, QC, March 29, 2016 /CNW Telbec/ – Today Biodextris Inc. announces its suite of services and commitment to building a full service contract organization. The new contract research organization (CRO) provides analytical and process development services for vaccines and biologics products. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Formerly part of GSK-Vaccines principal North American R&amp;D unit, the Biodextris team is comprised of key senior development scientists. Together they have developed dozens of products for early phase clinical trials conducted in the US, Canada and Europe. </span> </p> <p> <span> <br/> </span> </p> <p> <span> When GSK ceased operations at the Laval facility in 2015, the team capitalized on the opportunity to offer their collective industry expertise as an independent service provider. Multinationals as well as small and medium enterprises use Biodextris’ analytical and process development services to advance their candidate vaccine and biologic products from the bench to the clinic. </span> </p> <p> <span> <br/> </span> </p> <p> <span> “Our history within successful commercial organizations makes us an ideal partner to efficiently move products from candidate selection through clinical development”, commented Joseph Zimmermann, CEO of Biodextris. “The team’s passion, coupled with our capabilities and formal quality management systems, enable our vision to become a full service process development and manufacturing organization.” </span> </p> <p> <span> <br/> </span> </p> <p> <span> An advantageous location in Canada’s premier life-sciences hub, allows Biodextris to provide cost competitive services to companies in the clinical phases of product development for complex vaccine and biologics products. Biodextris will participate in the World Vaccine Congress in Washington on March 29-31, 2016, to highlight opportunities for vaccine companies. </span> </p> <p> <span> <br/> </span> </p> <p> <span> “Our Quality Management System is the backbone of everything we do”, said Christine Jacques, Analytical Services Director, “It is the reason large multinational pharmaceutical and innovative vaccine and biologics companies work with us.” </span> </p> <p> <span> <br/> </span> </p> <p> <span> About Biodextris: </span> </p> <p> <span> <span> Biodextris Inc. is a Canadian contract research organization (CRO), providing a suite of analytical and process development services for vaccines and biologics products in the clinical stages of development. The company’s analytical and product development expertise, established facilities and formal quality management systems enable their vision to become a full service process development and manufacturing organization. </span> </span> <a href="/"> www.biodextris.com </a> </p> <p> <span> <br/> </span> </p> <p> <span> SOURCE biodextris </span> </p> <p> <span> For further information: </span> </p> <p> <span> <span> Joseph Zimmermann, Biodextris Inc., </span> </span> <a href="mailto:joseph@biodextris.com"> joseph@biodextris.com </a> </p> </div> Thu, 31 Mar 2016 12:20:11 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/biodextris-keeps-team-together-to-provides-analytical-and-process-development-services English thumbnail main image https://www.biodextris.com/biodextris-profite-dun-nouveau-modele-daffaires Découvrez comment Biodextris adopte un nouveau modèle d'affaires pour soutenir l'innovation en biotechnologie et développement vaccinal. <div data-rss-type="text"> <p> <span> Publié dans La Presse, le 28 mars 2016. </span> </p> <p> <span> Pour voir l’ </span> <a href="http://affaires.lapresse.ca/economie/sante/201603/27/01-4965009-biodextris-profite-dun-nouveau-modele-daffaires.php" target="_blank"> article original </a> </p> <p> <span> <br/> </span> </p> <p> <span> L’industrie pharmaceutique est en grande transformation depuis plusieurs années, de nombreux centres de recherche ont été fermés au Québec, mais il y a moyen de tirer son épingle du jeu dans ce nouveau modèle d’affaires. </span> </p> <p> <span> <br/> </span> </p> <p> <span> C’est ce qu’ont décidé de faire les fondateurs de Biodextris, trois anciens employés du Centre de recherche et développement de GSK, à Laval. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Prenons l’exemple d’une entreprise de biotechnologies qui a conçu un vaccin contre le virus Zika. Elle a testé le vaccin sur des animaux. Ç’a été concluant. Elle souhaite maintenant poursuivre ses études cliniques sur des humains. Cela ne se fait pas en criant ciseau. Les molécules biologiques du vaccin doivent être produites dans un cadre très réglementé pour qu’on puisse les soumettre à des études cliniques. C’est ici que Biodextris entre en ligne de compte. </span> </p> <p> <span> <br/> </span> </p> <p> <span> « Ce n’est pas évident pour une entreprise de biotechnologies de réaliser ces étapes complexes parce que ça prend de l’équipement et il faut respecter les exigences complexes, par exemple, de Santé Canada ou de la Food and Drug Administration (FDA), aux États-Unis », explique Christine Jacques, cofondatrice et directrice des services analytiques chez Biodextris. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Or, les cofondateurs de Biodextris avaient développé cette expertise chez GSK. Ils ont décidé de la mettre à profit. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Les grandes entreprises pharmaceutiques ont aussi recours aux services de l’entreprise. </span> </p> <p> <span> <br/> </span> </p> <p> <span> « Le modèle d’affaires a changé et les grandes entreprises ne veulent plus nécessairement prendre en charge un produit avant les dernières phases des études cliniques parce que c’est très coûteux, alors ils font beaucoup de sous-traitance en recherche et développement. » </span> </p> <p> <span> <br/> </span> </p> <p> <span> – Christine Jacques, cofondatrice et directrice des services analytiques chez Biodextris </span> </p> <p> <span> <br/> </span> </p> <p> <span> UN TRAVAIL EN PLUSIEURS ÉTAPES </span> </p> <p> <span> <br/> </span> </p> <p> <span> Protéines, anticorps, enzymes : Biodextris travaille avec plusieurs types de produits biologiques utilisés dans la fabrication de médicaments et de vaccins. </span> </p> <p> <span> <br/> </span> </p> <p> <span> « Nous aidons nos clients à développer un procédé de fabrication robuste et fiable qui inclut la fermentation, la purification, la formulation et l’analyse de contrôle de la qualité du produit », explique Christine Jacques. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Une fois le procédé optimal trouvé, le produit peut être manufacturé dans un endroit qui respecte les « bonnes pratiques de fabrication » afin de pouvoir l’injecter à des humains. </span> </p> <p> <span> <br/> </span> </p> <p> <span> « Nous ne pouvons pas encore offrir ce service, mais nous souhaitons y arriver à court terme, affirme Mme Jacques. D’abord, parce que les entreprises veulent faire affaire avec le même fournisseur tout au long du processus pour éviter les risques liés au transfert de procédés. Puis, parce que très peu d’entreprises offrent ce service au Canada, alors bien des clients doivent faire fabriquer leurs produits biologiques aux États-Unis. » </span> </p> <p> <span> <br/> </span> </p> <p> <span> En plus du développement, Biodextris fait du contrôle de qualité de produits biologiques pendant toute la durée des études cliniques. Cela représente environ la moitié de ses activités. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Au démarrage, Biodextris a obtenu un contrat majeur qui a permis aux trois fondateurs d’embaucher cinq de leurs anciens collègues chez GSK. </span> </p> <p> <span> <br/> </span> </p> <p> <span> Les clients de l’entreprise sont canadiens, américains et européens. </span> </p> <p> <span> <br/> </span> </p> <p> <span> BIODEXTRIS EN BREF </span> </p> <p> <span> <br/> </span> </p> <p> <span> Secteur des biotechnologies </span> </p> <p> <span> <br/> </span> </p> <p> <span> Située dans la Cité de la biotech </span> </p> <p> <span> <br/> </span> </p> <p> <span> En activité depuis septembre </span> </p> <p> <span> <br/> </span> </p> <p> <span> Huit employés </span> </p> </div> Mon, 28 Mar 2016 12:22:27 GMT info@thewebsitestore.co (The Website Store) https://www.biodextris.com/biodextris-profite-dun-nouveau-modele-daffaires thumbnail main image