Biologics Gene & Cell Therapy

GMP Routine Testing Services

Biologics Gene & Cell Therapy

A State-of-the-Art GMP Laboratory

Our GMP laboratory is equipped with state-of-the-art, qualified instruments and staffed by highly trained scientists, enabling us to deliver top-quality CMC analytical services in compliance with current good manufacturing practices (cGMP).

Our analytical development and validation capabilities have supported clients’ biologics and cell and gene therapy (BCGT) pipelines through various stages of drug development.

We offer platform assays for GMP routine testing of biologics, cell and gene therapy drug substances and products. Additionally, we can facilitate the tech transfer of or qualify/validate your methods in our GMP laboratory for routine testing tailored to your needs. 

Platform Routine Testing Services 

  • Appearance (USP<1>) 
  • pH (USP<791>) 
  • Osmolarity (USP<785>) 
  • Subvisible Particles (USP<788>) 
  • Identity (ciEF, Peptide Mapping, ELISA, and SPR) 
  • Protein Concentration (A280) 
  • Potency (ELISA, Cell-based Assay) 
  • Product Purity and Impurity (cIEF, IEX-HPLC, RP-HPLC, HILIC, CE-SDS, SEC, and HIC) 
  • Glycan Profiling (HILIC, HILIC/MS) 
  • Extinction Coefficient Determination (Amino Acid Analysis) 
  • Surfactants (LC, LC/MS) 
    • Process Related Impurities 
    • Host Cell Proteins (ELISA) 
    • Host Cell DNA (qPCR, ddPCR) 
    • Protein A (ELISA) 
    • Cell Culture Medium Components (LC, LC/MS) 
  • Safety 
    • Bioburden (USP<61>) 
    • Endotoxin (USP<85>) 
    • Sterility (USP<71>) 
    • Mycoplasma (USP<63>)