There are a vast number of new and biosimilar monoclonal antibody (mAb) products in development and all of these will require extensive characterization for clinical trials to proceed and eventual release onto the market.
BioPharmaSpec scientists have been characterizing mAbs for over three decades and can work with you to devise the best structural and physicochemical characterization strategies for your development plans.
Regulatory guideline documents recommend that the following are assessed:
- Primary (de novo) Amino Acid Sequence
- Amino Acid Composition
- Terminal Amino Acid Sequence
- Peptide Map
- Disulfide Bridges
- Carbohydrate Structure
- Secondary and Tertiary Structure