Leachables & Peptide Stability: Science-Driven Risk Mitigation In Single-Use Drug Product Processing

Peptide therapeutics can be especially sensitive to interactions with materials used throughout drug product manufacturing. Extractables and leachables from single-use systems may introduce stability risks during fill–finish operations, making informed component selection and process design essential. Gain an evidence-based view of how these substances can affect peptide quality across the manufacturing chain, along with a structured framework for evaluating potential risks. Examine the role of sterilization processes in leachable profiles and explains how science-led decisions can help reduce unwanted interactions.

Learn how to identify sources of instability, assess their potential impact, and select single-use components that support peptide stability from initial design through final processing.