Quality of Raw Materials and Manufacturing of Advanced Therapies

07th October 2019 | 10.00 am EST | Fouad Atouf, Ph.D., Director, Biologics and Biotechnology, United States Pharmacopeia |BOOK FREE SEAT

The Success of a manufacturing process for cell based therapies, require the implementation adequate control strategies including control of raw and starting materials, in-process controls, testing of intermediate release specifications and stability monitoring. Traceablility and qualification of raw materials is an important step on this process. In this presentation, we will discuss the role of public standards in ensuring the quality of critical raw materials used in the manufacturing of advanced therapies.

Presented by Fouad Atouf, Ph.D., Director, Biologics and Biotechnology, United States Pharmacopeia

Fouad Atouf is Vice President, Science—Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics and antibiotics, and oversees the biologics laboratories in USP–U.S. and USP–India. His department supports the work of the associated USP Expert Committees. Dr. Atouf has been at USP for over 10 years and served in a variety of scientific leadership roles including being the regional champion for the Middle East and North Africa Region, where he helped facilitate programs designed to enhance the understanding of the role of regulations and standards in the registration of medicinal products. Dr. Atouf has strong background and experience in the development and regulation of cellular and tissue-based products. Prior to joining USP in 2006, his research at the U.S. National Institutes of Health focused on developing methods for the in vitro generation of cell-based therapies for diabetes. Dr. Atouf is the author of numerous publications in peer-reviewed journals and a frequent speaker at national and international scientific conferences. Dr. Atouf earned his Master’s degree in Biochemistry and his Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.


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