Course Description:
The US generic peptide drug market is valued at $62 billion USD in 2023 and is expected to increase in value as more generic peptide drug products are approved. Originator peptide drugs were commonly produced using recombinant DNA technology, however due to improved efficiency and cost, many generic peptide drugs are now produced using synthetic peptide synthesis. While the active pharmaceutical ingredient (API) and excipients within the formulation are equivalent between the reference and generic drug products, impurities derived from different methods of synthesis may differ between the two products. These peptide impurities have the potential to alter the immunogenicity risk profile of a generic drug compared to the originator. This concern is specifically addressed in the recent United States Food and Drug Administration (FDA) “ANDAs for Certain Highly Purified Synthetic Drug Products That Refer to Listed Drugs of rDNA Origin” where the agency recommends that generic drug applicants wishing to obtain ANDA approval for their generic peptides identify and describe all peptide impurities present in the final drug product that are present at a concentration greater than 0.10% of the API and determine if these impurities are different from those found in the RLD (reference listed drug).
Here we describe orthogonal approaches for evaluating the immunogenicity risk potential of peptide impurities as compared to their API peptides using a combination of in silico analysis and in vitro HLA-binding and T cell assays, highlighting examples that show the risk impurities pose to the immunogenicity of a generic peptide drug product. Additionally, we will discuss the need to standardized API peptide controls and peptide-specific positive and negative controls that can assist regulatory reviewers in assessing the quality of the immunogenicity data submitted as a part of their ANDA submissions. We will discuss how two novel in silico tools, the What if Machine (WhIM) and PeptiCAD, developed by EpiVax can be utilized to design standardized peptide controls that can be used across industry in T cell assays for the assessment of peptide impurity immunogenicity.
Who should participate:
- Regulatory scientists
- Analytical scientists
- Quality assurance analysts
- R&D scientists and managers
- Quality control analysts
- Contract research organizations
The live version of this recording took place during the USP Workshop on Therapeutic Peptides and Oligonucleotides: Regulations and Quality Standards on April 9-10, 2024 and features a presentation by Annie De Groot. Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.