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QC and Stability Testing Services
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.
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.
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 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
- 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
- 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
- qPCR: 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
- Visual Inspection (EP and USP): Observation according to noted standards
- Cell-based assays: Potency of target molecules