QC and Stability Testing

Companies rely on our Quality Control testing services for their clinical phase vaccines and biologics. cGMP studies are conducted following FDA and EMA guidelines.

BE CONFIDENT
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.

GC-MS (vials)
Centrifuge

STAY CONFIDENT
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

CATEGORY TECHNIQUE/EQUIPMENT OBJECTIVE
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
Colorimetry Color quantification
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
Description Product appearance