Description

This course offers a panoramic review of analytical method development and validation for therapeutic proteins, including antibodies and enzymes. It is intended for scientists working on therapeutic proteins in Analytical Development, Quality Control, Process Development or related functional areas. The course begins with a background on the development of therapeutic proteins, to include manufacturing of protein drugs, regulatory affairs issues, and basic aspects of protein chemistry. It will then discuss the fundamentals and practical aspects of commonly used analytical methods for proteins, including methods for structure elucidation, biophysical characterization, potency measurement, and purity and impurity analyses. The course then covers the strategy and common practice of method validation and method transfer, including regulatory compliance at different stages of product development, and the application of DOE and QbD. The course puts an emphasis on practical applications, real-world examples, and useful tips.

Instructor

Jichao Kang, Ph.D., Director, Analytical and Formulation Development, Laureate Biopharmaceutical Services, Inc.
Dr. Jichao Kang holds a Ph.D. in Pharmaceutics and has been working on characterization, method development, and formulation for proteins since 1995. He is an accomplished researcher with over 15 peer-reviewed journal articles and book chapters, several patents, and numerous conference presentations. He has extensive hands-on experience in most of the analytical methods for protein therapeutics. The proteins he has worked on extensively include antibodies, enzymes, and protein conjugates. His protein development experience encompasses preclinical, clinical, BLA and post-marketing commitments. He is currently the Director of Analytical Development and Formulation in Laureate Biopharmaceutical Services, Inc. Prior to Laureate, he was the department head of Analytical Development in Auxilium Pharmaceuticals, Inc. His team was one of the key parts in Auxilium's successful marketing application of Xiaflex in both US and EU. He also worked in MedImmune, PDL, and Neose Technologies.

Course Agenda

• Manufacturing process for therapeutic proteins
• Basic regulatory affairs knowledge
• Basic protein chemistry: structure, PTM, and degradations
• Protein quantitation (UV, colorimetric, fluorescence)
• Gel electrophoresis and Western Blot
• Capillary electrophoresis (cZE, cIEF, CGE, iCE280)
• Chromatography methods (RP, IEX, SEC, UPLC)
• Mass spectrometry
• Protein structure elucidation (MS/MS, peptide mapping , AAA, terminal sequencing)
• Biophysical characterization (CD, FT-IR, DSC, fluorescence)
• Protein aggregation and sub-visible particles (SEC-MALS, AUC, FFF, LO, MFI)
• Host cell proteins assay and host cell DNA assay (immunoassay, threshold assay, qPCR)
• Bioassays
• Method validation at different stages of product development
• Strategy and common pitfalls of method transfer
• Application of QbD and DOE in method development and validation