The implementation of Non-Coded amino acids to improve stability and function in therapeutic peptides is an active area of research. Many unnatural amino acid building blocks exist and are commercially available in quantities to enable SAR studies and early development. However, as scale is increased, the existing supplies may no longer be viable. This presentation will discuss the establishment of a supply chain for Fmoc alpha methyl quaternary amino acids. The focus will be on the development of manufacturing processes and an emphasis will be placed on specifications, key impurities, and manufacturing flexibility.

Subject area:
Biologics

Objectives (If applicable):
NA

Target Audience (If applicable):
QA Manager
QA Staff
QC Chemist
QC Manager
R&D
Regulatory
Student