OUR ANALYTICAL SERVICES
Tailored analytical solutions that meet the diverse needs of the pharmaceutical and biotech industries, and complies with any level of regulatory standards
Comprehensive GMP Analytical Services at Biodextris
Experts in developing complete analytical packages, including stability studies, to cover a wide array of biological and small molecule products.
Method
Development
Our team of talented scientists follow a systematic structured
methodology to develop each assay optimized for your product.
Method Validation
Our quality management system ensures validation policies are aligned with the ICH method validation guidelines ICHQ2(R1).
Method Transfer
With outward bound transfers we offer full support to help our clients and their partners get our new methods up and running.
QC and Stability
Testing
Companies rely on our Quality Control testing services for their clinical phase vaccines and
biologics.
Method Development
Biodextris supports you in the design of a suite of analytical assays that assess the important and critical quality attributes for your unique product. Our team of talented scientists follow a systematic structured methodology to develop each assay optimized for your product.
Method Validation
Validation of a method is a critical step of development work. We, at Biodextris, validate your assays to demonstrate that the appropriate performance criteria are met, and the analytical target profile is achieved. Our quality management system ensures validation policies are aligned with the ICH method validation guidelines ICH Q2(R1).
We assess and verify the following assay parameters as appropriate for your project:
- Specificity
- Range
- Accuracy
- Precision
- Repeatability
- Intermediate Precision
- Linearity
- Detection Limit
- Quantification Limit
- Robustness
USP methods are performed as defined, or are adapted, customized and validated as appropriate.
Method Transfer
Our clients and their situations are all different and as such Biodextris can offer up a wide array of options when it comes to method transfer. On inward bound method transfers we can take in a method and simply transfer and execute, or if requested, we can offer our expertise to further optimize it.
With outward bound transfers we offer full support to help our clients (and their partners) get our new methods up and running with comprehensive documentation and access to our team’s expertise. Quality is our guarantee!
QC and Stability Testing
Clinical Drug Substance - Product Analysis
We support you to confidently release your clinical product by executing validated assays which form the backbone of your product monograph or IND CMC section, and establish the quality, efficacy and safety of your product.
Our technologies allow complete analysis of bulk drug substance and liquid or lyophilized drug product, and the validated analytical methods are performed under rigorous quality oversight, following defined standard operating procedures.Your data integrity is assured and your results are handled securely.
Clinical Drug Substance - Product Stability
We help you build a stability plan that captures the essential storage-dependent characteristics of your product to verify quality, efficacy and safety are maintained and providing critical shelf-life determination data. The curated selection of stability-indicating assays are implemented at the defined time-points, and validated storage conditions are employed. Be assured that your stability assays are never considered routine by our diligent scientific team.
Available Analytical Technologies
Physico-chemical
cIEF
— Capillary IsoElectric Focusing
Separation of protein variants
HPLC-RP/IEX with PDA/CAD/Fluo
— Photo Diode Array, Charged Aerosol or Fluorescence detection
Content or purity determination of proteins or small molecules.
LAL Endotoxin
— Limulus Amebocyte lysate assay
Quantification of residual LPS or endotoxin
UPLC-PDA-MS/MS
— Ultra Performance Liquid
Chromatography with Photo Diode Array or Tandem Mass Spectroscopy detection
Multi-analyte determination
Colorimetry
— Optical density, absorbance,
transmission and fluorescence
Optical quantification, BCA, Lowry etc.
SDS-Page
— Sodium Dodecyl Polyacrylamide Gel Electrophoresis
Size separation and purity
determination
Biophysical
SEC-MALLS
— Size-Exclusion Chromatography with Multi- Angle Laser Light Scattering
Direct molar mass and size distribution
SEC-FLUO/UV
— Fluorescence or UltraViolet detection Size Exclusion
Chromatography
Aggregation
determination
DLS
— Dynamic Light Scattering
Particle size and size
distribution determination
Nephelometry
Detection of insoluble
particles
Immunological
Western Blot
Size separation and antigen specificity characterization or product identity confirmation
ELISA
— Enzyme-Linked
ImmunoSorbent Assay
Antigenic activity, identification, antigen quantification, and ELISA multiplex by MSD
qPCR
—Quantitative Polymerase Chain Reaction
Quantification of target or residual DNA, product identity confirmation and viral titer
SRID
— Single Radial
Immunodiffusion
Hemagglutinin
potency assay
General
CCIT
— Container Closure Integrity Testing
Vacuum testing of vials and other containers
pH
— Aqueous solutions
Levels of acidity or alkalinity determined
Conductivity
Measurement of purified water and buffer solutions
conductivity
TOC
— Total Organic Carbon analysis
Water quality assessment through quantitative
measurement of organic compounds in samples
Cell count - Particle count
Particle sizing from 0.2 - 1600 μm in liquid samples using beckman coulter’s 4e
multisizer
Turbidity
Measurement of relative clarity of a liquid against guidelines or specifications
Viscosity
— Brookfield method
Viscosity or flow
resistance of liquid in stated conditions
Photostability
Simulated prolonged
light exposure stability studies
Visual Inspection
— EP and USP
Observation according to noted standards
Cell based assays
Potency of target
molecules and Tissue Culture Infectious Dose (TCID50)
Bioburden
Microbial load of surfaces, materials or samples
GET IN TOUCH WITH OUR FRIENDLY TEAM
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