Analytical services
We cover a wide array of biologic and small molecule products
Choose Biodextris for your GMP analytical needs as we are experts in developing complete analytical packages, including stability studies, to cover a wide array of biologic and small molecule product.
Analytical services
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 ICH Q2(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.
Availablie Analytical Technologies
| CATEGORY | TECHNIQUE/EQUIPMENT | OBJECTIVE |
|---|---|---|
| Physico-chemical | Capillary isoelectric focusing (cIEF) | separation of protein variants |
| Microfluidic electrophoresis | automated protein sizing and relative quantitation | |
| HPLC-RP/IEX/SEC with PDA/CAD/Fluo: High Performance Liquid Chromatography with Reverse Phase/Ion-Exchange/Size-Exclusion with Photo Diode array or Charge Aerosol or Fluorescence detection | Content or purity determination of proteins or small molecules | |
| GC-MS: Gas-Chromatography Mass Spectrometry | Separation, identification and quantification | |
| ICP: Inductively-Coupled Plasma | Trace element identification | |
| UPLC-PDA-MS/MS: Ultra Performance Liquid Chromatography with Photo Diode Array or Tandem Mass Spectroscopy detection | Multi-analyte determination | |
| LAL Endotoxin: Limulus amebocyte lysate assay | Quantification of residual LPS or endotoxin | |
| Colorimetry (optical density, absorbance and transmission) cuvette and multiwell plate. | Optical quantification, BCA, Lowry etc. | |
| SDS-PAGE: Sodium Dodecyl Sulfate 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 | |
| FFF-MALLS: Field Flow Fractionation with Multi-Angle Laser Light Scattering | Molar Mass and size distribution determination | |
| SPR (surface plasmon resonance) | Real time binding and dissociation data data | |
| DLS: Dynamic Light scattering | Particle size and size distribution determination | |
| Nephelometry | Detection of insoluable particles | |
| Immunological | Western Blot | Size separation and antigen specificity characterization |
| ELISA: Enzyme-Linked Immunosorbent Assay | Antigenic activity and identification | |
| Threshold DNA | Quantification of target or residual DNA | |
| SRID: Single Radial Immunodiffusion | Hemagglutinin potency assay | |
| General | Osmolality: Aqueous/freeze dried solutions | Enumeration of moisture content |
| pH: Aqueous solutions | Levels of acidity or alkalinity determined | |
| 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 | |
| Description: Visual Inspection (EP and USP) | Observation according to noted standards |