Peptide therapeutics are a unique class of pharmaceuticals that may be regarded, in regulatory terms, as either conventional chemical molecules, biological entities or biosimilars. Slight changes in the structure, physicochemical properties, stability, and impurity profile of a peptide can provoke an adverse immune response therefore safety assessment is critical. Building a well-thought-out quality control (QC) strategy is key to meeting development milestones and complying with evolving regulatory requirements. 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. Programs should be tailored to a peptide of interest to ensure precision, selectivity, and confidence in the results generated. 


In this webinar, our expert Ashleigh Wake, UK Business Director at Intertek Pharmaceutical Services introduces the regulatory and scientific considerations for peptide development and describes key analytical approaches for biophysical characterization, higher-order structure, aggregation, disulphide-bond analysis, and product-related impurity analysis which are required as part of a robust peptide quality control program.


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