Julie Zhang
Team lead U.S. Pharmacopeia
Julie Zhang is a team leader in Biologics at USP. Her group is responsible for documentary standard development for a variety of products from peptides, proteins to complex biologics. Dr. Zhang has strong background and experience in the development and regulation of drug products. Prior to joining USP, she worked in pharmaceutical companies with strong analytical experience in the development and regulation of drug products such as method development and validation. Dr. Zhang earned her Ph.D. in Chemistry from University of Maryland Baltimore County.
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?
