Qualification of Raw Materials Used In the Manufacturing of Cellular Therapies


07th October 2019 | 10.00 am EST | Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia and Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River |WATCH FOR FREE

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 Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia

Dr. Richardson works in the standards pipeline development group within Global Biologics at USP, leading efforts to develop standards for emerging technologies such as cell and gene therapy. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious and retinal diseases. Trained as a virologist, Jim has also held positions responsible for performing viral clearance testing at Viromed Biosafety and AAV vector development and characterization at Genovo/Targeted Genetics. Dr. Richardson earned his Ph.D. in Biomedical Sciences at the Mount Sinai School of Medicine.

Followed by Viral Safety Aspects of Raw Materials Used in the Production of Biologics Including Cellular Therapy Products

After a short review of regulations/guidance related to viral safety aspects of raw materials the in principle concept for ensuring viral safety will be outlined. The viral risk profile of a raw material is defined based on the source material, the sourcing process and the subsequent manufacturing and/or purification process. Testing for viruses performed on the start material and/or process intermediates is one way to mitigate the viral risk. Different methods for testing will be presented and the pros and cons discussed. Analyzing the viral clearance capacity of the manufacturing process is another important strategy to reduce the viral risk significantly if applicable. There are, however, experimental challenges sometimes which makes it difficult to demonstrate efficient viral clearance even though the treatment is known to be highly efficient.

Presented by 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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