TS5B: INTRODUCTION TO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR BIOLOGICS PRODUCTS

Wednesday, AUGUST 14  and Thursday, August 15
DAY ONE: 8:00 AM – 6:00 PM | DAY TWO: 8:00 AM – 12:15 PM

Waterfront 1AB

INSTRUCTOR:

Jichao (Jay) Kang, PhD, RAC, Director, Analytical Development, Amicus Therapeutics

This course is a panoramic review of analytical method development and validation for Biologics products, including antibodies, enzymes and gene therapy products. It starts with basic knowledge of work on biologics: manufacturing, regulatory affair knowledge, and essential technical knowledge. It then discusses the fundamentals and practical aspects of commonly used analytical methods for biologics, including methods for structure elucidation, glycan characterization, biophysical characterization, potency measurement, and purity and impurity analysis. The course concludes with the strategy and common practice in method validation and method transfer, including regulatory compliance at different stages of product development, application of DOE and QbD. The course emphasizes practical applications, real-world examples and useful tips.

AGENDA:

• Manufacturing process for therapeutic proteins and gene therapy products
• Basic regulatory affair knowledge
• Basic protein chemistry: structure, PTM and degradations
• Quantitation of protein and nucleic acid
• Gel electrophoresis and Western Blot
• Capillary electrophoresis (cZE, cIEF, CGE, iCE280, Labchip)
• Chromatography methods (RP, IEX, SEC, UPLC)
• Mass spectrometry
• Protein structure elucidation (MS/MS, peptide mapping, AAA, terminal sequencing)
• Glycosylation and glycan characterization
• Biophysical characterizations (CD, FT-IR, DSC, fluorescence)
• Aggregation and subvisible particles (SEC-MALS, AUC, FFF, LO, MFI)
• Host cell proteins assay and host cell DNA assay (immunoassay, threshold assay, qPCR, ddpCR)
• Bioassay (enzymatic activity, binding and cell-based assay)
• Method validation at different stages of product development
• Strategy and common pitfalls of method transfer
• Application of QbD and DOE

BENEFITS

• Gain a complete picture of analytical method development and validation process
• Gain a basic understanding of commonly used analytical methods for proteins and gene therapy products

WHO SHOULD ATTEND

• Analytical development scientists, process development scientists, QC analysts, regulatory affair managers, project managers and quality assurance managers

INSTRUCTOR BIOGRAPHY:

Jichao (Jay) Kang, Ph.D., RAC, Director, Analytical Development, Amicus Therapeutics

Dr. Jichao Kang holds a Ph.D. in Pharmaceutics and has over 20 years of experience in Biologics development. He is an accomplished researcher with over 20 peer-reviewed journal articles and book chapters, several patents and numerous conference presentations. He has extensive hands-on development experience in antibodies, enzymes, protein conjugates and gene therapy products. He is a key contributor in over 50 IND/IMPD projects and over a dozen of late phase and BLA/MAA projects. He is currently the Director of Analytical Development at Amicus Therapeutics. Prior to Amicus, he was the Director of Analytical and Formulation Development at Patheon Biologics, part of Thermo Fisher Scientific. He also worked with increased responsibilities in Protein Design Labs, Neose Technologies, MedImmune, and Auxilium.

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.