2021 FDA Science Forum
Quality Considerations in Solid Phase Peptide Synthesis: A Case Study with Liraglutide
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
Liraglutide injection (RLD: Victoza ®) is a synthetic peptide drug to control blood sugar levels in adults with type 2 diabetes. Liraglutide API contains 31 amino acids with a C-16 fatty acid attached. In this case study, it is manufactured by Solid Phase Peptide Synthesis (SPPS). This manufacturing process is highly complex with numerous reaction and purification steps, which can collectively have considerable impact on the identity, strength and purity of the peptide. As a result, regulators often face significant challenges in determining the safety profile of the final peptides. In this poster, by using Liraglutide as a case study, we outline common quality considerations in SPPS that will aid regulators' manufacturing process assessment. This is achieved by providing examples of common manufacturing process deficiencies as well as recommended control strategies to mitigate the safety risk to patients. Quality considerations described herein will facilitate regulators in assessing critical aspects of SPPS manufacturing, thereby protecting the patients from increased safety risk as well as promoting quality peptide drugs for public health.
