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Biopharmaceutical Characterization and Development

EAG has 45 years of experience in method development, bioassays, and protein chemistry, and a broad array of advanced analytical techniques and laboratory instrumentation. Our analytical methods, assay and bioassays, full characterization and quantification of biomolecules, post-translational modifications (PTMs) and degradants biomolecule drug substance and drug product are performed under cGMP. This includes amino acid analysis, molecular weight determination, protein isoform and glycosylation profiling, peptide mapping, carbohydrate analysis and bioassays;

EAG offers cGLP and cGMP analytical and product development services, including comprehensive characterization for protein and oligonucleotide biopharmaceutical products. Biopharmaceutical services include:

  • Biopharmaceutical product characterization
    • Complete sequencing (Peptide map/QToF MS)
    • Post-translational modifications (PTMs)
    • Protein isoforms and glycosylation profiling
    • Drug/Antibody Ratio (DAR)
    • Degradants
    • Disulfide linkages
    • Charge variants, truncations, amino acid substitutions
    • Molecular weight
  • Method feasibility, development, validation and transfer
  • Cell bioassay method optimization and validation (cytotoxicity, reporter and proliferation)
  • Dose formulation/compatibility studies
  • IND and clinical bioanalytical support
  • CMC support for regulatory submissions

EAG has a wealth of experience with a wide variety of biopharmaceutical products including:

  • Monoclonal Antibodies
  • Antibody Drug Conjugates (ADC)
  • Biosimilars
  • Fusion Proteins
  • Pegylated protein
  • Oligonucleotides
  • Peptides
  • Vaccines