For synthesis of peptides, conventional approach utilizes linear solid phase peptide synthesis (SPPS) that is known to produce Des impurities, conformational changes and/or close eluting impurities. Co-generation of these impurities adversely affect the purity profiles of the final product. Case studies with novel proprietary processes for two synthetic therapeutic peptides would be presented wherein these synthesis-related challenges get mitigated robustly. Further, utilization of greener chemistry approaches for the peptide synthesis would be discussed. Specifically, for SPPS, most of the available solvents lead to higher carbon footprint making the process non environmental friendly. Furthermore, several of the commercially available green solvents are unsuitable for efficient synthesis. Based on literature studies and process understandings, a new synthetic and greener approach for peptides was developed and will be discussed in addition to the criteria for SPPS solvent selections. The regulatory and commercial impact of the use of green solvents also will be a point of discussion. The live version of this recording took place during the USP Workshop on Therapeutic Peptides and Oligonucleotides: Regulations and Quality Standards on April 9-10, 2024.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
– Regulatory scientists
– Analytical scientists
– Quality assurance analysts
– R&D scientists and managers
– Quality control analysts
– Contract research organizations