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CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics

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CMC: A Solutions-Based Approach from Small-Molecule Drugs to BiotherapeuticsPresentation by Michael W. Dong, Ph.D.

An Overview of Key Differences of the CMC Process in Small-Molecule Drugs and BiotherapeuticsPresentation by Joseph L. Glajch, Ph.D.

Expert Forum Panel Discussion

Presenters / Panellists

Presenters / Panellists
Dr. Michael DongPrincipal ConsultantMWD Consulting (USA)Dr. Michael W. Dong is a principal consultant at MWD Consulting, focusing on consulting and training services on HPLC, pharmaceutical analysis, and drug quality. He was formerly a Senior Scientist in Analytical Chemistry and Quality Control at Genentech, a Research Fellow at Purdue Pharma, a Senior Staff Scientist at Applied Biosystems/Perkin-Elmer, and a section head at Celanese Research Company. He holds a Ph.D. in Analytical Chemistry from the City University of New York. He has 130+ publications and five books, including a bestselling book on chromatography (HPLC and UHPLC for Practicing Scientists, 2nd Ed., Wiley, 2019). He is an advisory board member of LCGC magazine.
Dr. Joseph GlajchPrincipal ConsultantJLG AP Consulting (USA)
Dr. Ewoud van TrichtPrincipal Consultant & Co-OwnerKantisto (The Netherlands)Expert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.

Moderators

Moderators
Prof. Dr. Cari Sänger-van de GriendScientific DirectorBioQCExpert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.

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