OUR DEVELOPMENT SERVICES

Tailored solutions for upstream and downstream process development, tech transfer, and process validation.

Development Services

Choose Biodextris for your rapid delivery of robust and reliable production processes, ready for manufacturing of your vaccine or biologic

Upstream Process

We aim to identify and control the key process parameters that will provide your product with the optimal set of critical quality attributes.

Downstream Purification

We will help you develop, assess and optimize a downstream purification strategy to isolate your product.

Process Transfer

Our expertise helps our clients contain costs, manage risk and maintain key process knowledge, by employing a systematic approach to process transfer.

Method Transfer

Process Development

Biodextris is an expert in accelerating our client’s projects from the
bench to the clinic. We efficiently deliver robust and reliable
production processes ready for manufacturing a wide array of vaccines and biologics. We offer comprehensive process development activities for complex biological products in the following areas :

  • Recombinant purified proteins
  • Cell membrane preparations
  • Complex multi-component systems
  • Whole cell based products
  • Monoclonal antibodies




Our clients span the globe as well as sectors from agricultural applications, to diagnostics and of course our cores in human health based biologics and vaccines.

Throughout the execution of our process development strategy, our analytical services team develop appropriate assays to ensure your product is properly characterized and enumerated accurately, insuring the product meets or exceeds your expectations. Click here for more details about our Analytical Method Development.

Upstream Development

Biologics are produced via a variety of methods and all sorts of microorganisms (bacteria, yeast, fungi and eukaryotic cells). At Biodextris, we are experts with many of the species used in industry. From the beginning, we aim to identify and control the key process parameters that will provide your product with the optimal set of critical quality attributes.

Biodextris can be your guide navigating through the following activities in establishing an upstream process:

  • Media evaluation
  • Host strain evaluation
  • Cell line development
  • Development of batch or fed-batch protocols
  • Product optimization strategies (yield increase, reducing undesired product)
  • Analytical parameters

We develop your upstream process using industry leading pilot-scale fermenters and bioreactors. Our systems are interfaced for continuous monitoring, control and data acquisition or temperature, pH, agitation, airflow, pressure, dissolved oxygen, exhaust gas (O2/CO2) and nutrient feeds all in a GMP clean room
environment where applicable.

Downstream purification

Many see downstream purification as a mixture of art and craft, however, at Biodextris we make it science! We have extensive experience separating our client’s Target products from complex matrices by developing, assessing and optimizing a downstream purification strategy.

With our expertise and equipment, we effectively isolate your product while preserving its identity, purity, potency and homogeneity. Our comprehensive
analytical group work in tandem to ensure all these parameters are properly analyzed and documented.

We will lead you through phase-appropriate activities such as resine screening, chromatographic protocol development, protein compatibility studies, accelerated stability studies, process robustness and pre-formulation testing leading to a comprehensive downstream package ready for manufacturing.

We use industry leading AKTA Avant and Pilot systems for performance of various chromatography methods including ion exchange, hydrophobic interaction, reverse phase and size exclusion chromatography as well as tangential flow filtration and sterile filtration.

Process transfer

At Biodextris, we can supply material for early stage clinical trials, but with a client’s success come larger scale needs. Our team is well equipped to transfer your production process to a large-scale partner cGMP facility. We have extensive experience with small and medium
sized biotechnology companies, large pharmaceutical and large vaccine manufacturers, government organizations and CMOs. Biodextris is truly an international organization having a well-versed multicultural team and clients across Canada, USA and Europe and Asia.

Our expertise helps our clients contain costs, manage risk and maintain key process knowledge. We employ a systematic approach to process transfer that includes the following :

  • Control scale-related process variations
  • Control equipment related variations
  • Management and execution of transfer lots
  • Comprehensive training
  • Knowledge management

GET IN TOUCH WITH OUR FRIENDLY TEAM

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