The peptide market is booming. With 120 peptides approved by 2024, over 700 in preclinical development, and 350 in clinical development, scientists are expecting this market to become even more mainstream. This growth is driven by the increasing approval of peptides for various indications, including metabolic disorders, cancer, and other diseases.
Vera D’aloisio, Business Development Manager at Bachem kicked off her presentation by introducing her company which employs a strategic CMC framework for drug development. Their approach follows a stage-wise structure that helps ensure preparedness for clinical phases while minimising initial investment.
The pre-clinical phase of the CMC framework consists of a feasibility study, a tox batch for in vivo non-human studies, and then purity qualification. The next phase is a clinical one that begins with validating analytical methods before moving to process development. D’aloisio added that Bachem has work packages to optimise the SPPS process where examining coupling efficiencies, different resins, and different solvents is important.
Two projects were highlighted to demonstrate the flexibility of the CMC framework. One project, a Glucagon analogue, required minimal process development due to its robust initial process. The other, a hybrid GLP molecule with a fatty acid tail, required extensive process development and early risk analysis to address its complexities.
D’aloisio encouraged the audience to check out PepTherDia, a database of approved peptide therapeutics that provides information on structural analysis and indications. She also stressed that researchers should not only look at peptides for metabolic disorders but also for cancers and infectious diseases examples. Even in the chronic disease space, there is potential for peptides, for instance, J&J is collaborating with Protagonist Therapeutics to develop JNJ-2113 (formerly PN-235) to treat psoriasis.
Bachem is a major contributor to the peptide market: it supplies over 40% of peptides on the market and is currently working on over 150 NCE (New Chemical Entity) projects. Overall, the company’s diverse portfolio and tailored CMC framework position them well to support this expanding market.
