Our team of talented scientists follow a systematic structured
methodology to develop each assay optimized for your product.
Method
Development
Our quality management system ensures validation policies are aligned with the ICH method validation guidelines ICH Q2(R2).
Method
Validation
With outward bound transfers we offer full support to help our clients and their partners get our new methods up and running.
Method Transfer
Companies rely on our Quality Control testing services for their clinical phase vaccines and biologics.
QC and Stability Testing
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
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.
cIEF
Capillary IsoElectric Focusing
Separation of protein variants
HPLC-RP/IEX with PDA/CAD/Fluo
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
Colorimetry
Optical density, absorbance,
transmission and fluorescence
Optical quantification, BCA, Lowry etc.
SDS-Page
Size separation and purity
determination
Sodium Dodecyl Polyacrylamide Gel Electrophoresis
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
DLS
Dynamic Light Scattering
Nephelometry
Immunological
Western Blot
ELISA
Enzyme-Linked ImmunoSorbent Assay
qPCR
Quantitative Polymerase Chain Reaction
Quantification of target or residual DNA, product identity confirmation and viral titer
SRID
Single Radial Immunodiffusion
General
CCIT
Container Closure Integrity Testing
pH
Aqueous solutions
Conductivity
TOC
Total Organic Carbon analysis
Cell count - Particle count
Particle sizing from 0.2 - 1600 μm in liquid samples using beckman coulter’s 4e multisizer
Turbidity
Viscosity
Brookfield method
Photostability
Simulated prolonged light exposure stability studies
Visual Inspection
EP and USP
Cell based assays
Potency of target molecules and Tissue Culture Infectious Dose (TCID50)