- Sponsored Content
Peptide Therapies: Designing a Science-Led Strategic Quality Control Program
Sponsored by Intertek
Peptide therapeutics are a unique class of pharmaceuticals. They can fall into one or more regulatory categories: as conventional chemical molecules, biological entities, or biosimilars. Developing a well–thought-out quality control (QC) strategy is key to meeting development milestones and complying with evolving regulatory requirements. Safety assessment is critical because slight changes in the structure, physicochemical properties, stability, and impurity profile of a peptide can provoke an adverse immune response. A robust analytical QC program should be conducted in laboratories that comply with good manufacturing practices (GMPs) to help establish and meet specifications, supporting regulatory submissions. These programs should be tailored to a peptide of interest to ensure precision, selectivity, and confidence in the results generated. A careful selection of techniques is key. This Special Report introduces the regulatory and scientific considerations for peptide development and key analytical approaches for biophysical characterization, higher-order structure, aggregation, disulfide-bond analysis, and product-related impurity analysis, which are required as part of a robust peptide QC program.
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Mar 11 - Mar 14, 2024
Mar 11 - Mar 14, 2024
Accelerate speed to market for your next generation mAbs, vaccines, cell therapy, and gene therapy products. At the BioProcess International US West event in San Diego, CA, in March 2024 you can access today's innovative strategies and technologies designed to improve process efficiencies and maintain product quality across all phases of bioprocessing.Agenda