Companies rely on our Quality Control testing services for their clinical phase vaccines and biologics. cGMP studies are conducted following FDA and EMA guidelines.
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||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|
|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|
|DLS: Dynamic Light scattering||Particle size and size distribution determination|
|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||pH Aqueous solutions||Potentiometric measurement|
|Osmolality||Evaluation of solution osmolality|