Biopharmaceutical Services (BIO) (Large Molecules, Cell & Gene Therapy Products)

Biochemical Characterization

• Molecular weight determination
• Amino acid composition
• Glycosylation assay (glycans, sialic acid, mono-saccharide) by Ion Chromatography
• Replication competent lentivirus (RCL)
• Virus copy number determination (CTPs)

Analytical and Stability Services

Purity

• HPLC: SEC; charge heterogeneity; aggregation
• Capillary Electrophoresis (CE): cIEF, CE-SDS,
• Flow cytometry: for cell therapy products (CTPs)

Impurity Analysis

• ELISA assays: HCP, rPA, Customized impurities
• Residual host genomic DNA by qPCR
• Flow cytometry for cell therapy products

Specific Assays for Final Drug Products

• Tween-20 determination
• Customized component determination for formulation buffer

Potency Determination

In-vitro cell-based potency assays for monoclonal antibodies, peptides, CGTPs on multiple platforms (Alpha, ABS, Fl and Lum etc.)

• High content imaging assays
• Reporter gene assays
• ADCC, CDC & ADCP assays
• Customized cell based assays

• Immunoassays and ligand-binding assays as surrogate potency assay

• PCR for gene therapy products

• Customized potency assays

Other Assays

• Lentivirus titration assay
• Identity assays for Cell and Gene Therapy Products

Cell Line Services

• Cell line screening and optimization
• Cell culture procedure/medium optimization
• Master and working cell bank (MCB & WCB) creation for manufacturing purposes
• MCB, WCB and Assay ready cell bank (ARCB) for analytical purpose
• Cell bank qualification (purity & functionality)
• Cell bank storage, inventory management and distribution

Bioanalytical and Immunogenicity

• Pharmacokinetics and toxicokinetics (PK/TK)
• Biomarkers
• Immunogenicity assays:
  • Anti-drug antibody analysis: screening, confirmation, and titration
  • Cell-Based Assays for Neutralizing antibody (NAb) determination