Qualification of Raw Materials Used In the Manufacturing of Cellular Therapies

07th October 2019 | 10.00 am EST | Fouad Atouf, Ph.D., Director, Biologics and Biotechnology, United States Pharmacopeia and Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River |BOOK FREE SEAT

Qualification of raw materials used in the manufacturing of cellular therapies requires the use of risk assessment strategies to categorize the critical components of a manufacturing process. In addition to cell culture supplements, excipients and other formulation’s components must meet the required quality to ensure consistency in manufacturing and subsequently the quality and safety of finished cell therapy products. This presentation will discuss the critical challenges facing the development of cell therapies, and the type of qualification programs to help ensure consistency in the manufacturing of cell and gene 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.

And Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River’s Biologics Testing Solutions

Dr. Horst Ruppach studied chemistry at the University of Cologne and the University of Marburg, Germany and earned his PhD in Virology (HIV) at the Georg Speyer House, Frankfurt. He has 25 years of experience in the field of virology. His expertise is in virus safety testing and virus/prion clearances studies requested for biopharmaceuticals and medical devices using animal or human derived materials. He is currently responsible for the business development of Charles River’s viral clearance and virology service globally.

Sponsored by Charles River’s Biologics Testing Solutions

Charles River’s Biologics Testing Solutions division provides tailored global testing and manufacturing services to support clients throughout the development cycle, from discovery through preclinical and clinical studies to marketed product release. We have the capabilities to address the needs of clients based anywhere in the world and have specialized programs for companies that focus on vaccine, gene and cell therapy, and biosimilar development.

Charles River’s Biologics Testing Solutions group offers a variety of GMP/GLP services including, but not limited to:
• contamination and impurity testing
• viral safety and viral clearance studies
• cell banking and cell line characterization
• in vitro and in vivo bioassays
• protein characterization
• stability and lot release testing
• formulation development
• contamination and impurity testing
• anti-infective and vaccine challenge studies

Whether clients need stand-alone tests, a unique package of services, or insourced support, Charles River can create a custom solution to suit client needs. With Charles River supporting 85% of drugs approved by the FDA in 2018, leverage our experience and expedite time to market. Visit our website, criver.com/biologics or contact us today at +1 (877) 274-8371.

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