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

We provide high quality biopharmaceutical services including analytical methods, biochemical characterization, cell line, bioanalytical and immunogenicity.

Our team offers unsurpassed skill and experience in method development, optimization, qualification/validation and tech transfer for biopharmaceutical products (covering monoclonal antibodies, peptides, CGTPs, oligo-nuleotides, ADCs and biosimilars), sample analysis and stability services to support CMC portfolio, routine lot release, and drug development.

Biochemical Characterization

  • Molecular weight determination
  • pI determination
  • Amino acid composition analysis
  • Peptide mapping with HPLC or LC/MS/MS
  • Glycosylation assay (glycans, sialic acid, mono-saccharide)
  • Amino acid sequence & composition
  • Post modification (glycosylation, glycation, phosphorylation, deamidation, oxidation, carbamylation)
  • Disulfide bridge (by extended LC-MS/MS peptide mapping studies or electrospray MS and colorimetric tests for free sulfhydryl groups)
  • 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 CGTPs

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

Dedication, Quality, Experience.

Find out how Primera does it better.