Biopharmaceutical Characterization and Development

Biopharmaceutical characterization is among the most challenging of drug development activities. It requires a broad base of technical expertise, state-of-the-art instrumentation and experience  interpreting biomoleculer structure. Time and again, EAG scientists have demonstrated their ability to successfully characterize the most structurally complicated molecules—monoclonal antibodies, Antibody-Drug Conjugates (ADCs) and pegylated proteins. In doing so, we’ve helped numerous biopharmaceutical innovators expedite the path to clinical studies, and earned a reputation as an industry leader in biopharmaceutical analyses.

A Proven Track Record for Expediting Biopharmaceutical Development

Complete characterization of a biopharmaceutical is an absolute requirement, not only for a thorough understanding of the molecule, but a regulatory prerequisite to conducting first-in-man studies. Our growing biopharmaceutical development team has provided full characterization of more than a dozen ADCs and mAbs in the last three years. Six of these were part of  successful IND applications and had no FDA observations or questions.

Biopharmaceutical characterization includes:

  • Complete sequencing (Peptide map/QToF MS)
  • Post-translational modifications (PTMs)
  • Protein isoforms (charge variants, truncations, amino acid substitutions)
  • Glycosylation profiling
  • Drug/Antibody Ratio (DAR)
  • Degradants (oxidation, deamidation, truncations…)
  • Disulfide linkages
  • Intact/sub-unit  mass

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