Kevin Carrick
Senior Director, Global Biologics U.S. Pharmacopeia
Kevin Carrick is a Senior Director of Science & Standards in USP’s Global Biologics Department. Dr. Carrick and his team work with the USP Expert Committees and Expert Panels to develop standards that support complex pharmaceutical quality assessment. Dr. Carrick has over 20 years experience characterizing complex therapeutics and standards development. These standards include documentary (monographs and general chapters) and physical reference standards for varied products including peptides, proteins, vaccines, and advanced therapies.
Seminars
In the dynamic landscape of peptide therapeutics, the development of robust analytical strategies is crucial for ensuring the efficacy when translating from discovery to clinic. This workshop delves into the intricacies of standards and tools, with regulatory insights to provide a comprehensive overview of cutting-edge techniques and best practices essential for characterizing and purifying recombinant and synthetic peptide products..
Key topics include:
- How to manage the analytical development life cycle?
- What are the new analytical approaches for peptide characterization?
- What are the quality challenges that exist?
- What approaches are being used to look at innate and adaptive immune systems and where is the regulatory agency pushing them towards?
- What are the current regulatory guidances?
