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Assessing Animal-Derived Raw Materials for Viral Risk

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In the realm of biologic manufacturing, the risk of introducing an infectious virus into the drug substance bulk harvest is one of the fundamental concerns articulated within the International Council for the Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin.

Why the concern? Have there been known viral contamination events leading to lot rejection during biologic manufacture? The answer is yes, though rarely. These events often have been attributed to the use of animal-derived raw materials (ADM), such as fetal bovine serum or porcine trypsin. Have such viral contaminants ever made it into commercial drug products administered to humans? Yes, two instances come to mind.

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About the Author

Raymond Nims, PhD

Raymond Nims, PhD, is a consultant at Syner-G, joining in 2009. He brings over 49 years of experience in the biomedical sciences.
From 2006 to 2009, Ray served in Amgen’s corporate Quality Control group, providing subject matter expertise in viral and mycoplasma testing of raw materials and products, and serving as business process owner for Amgen’s global contract analytical testing lab outsourcing program. From 1994 to 2006, Ray directed laboratories at BioReliance performing viral safety, endotoxin, and cell line identity studies for biologics cell line characterization, raw material testing, and product lot release testing.

Raymond obtained a PhD in chemistry (chemical toxicology) at The American University, Washington, DC. He currently serves on the editorial board for the BioProcessing Journal and has served on the ad hoc advisory boards for USP chapters 1237, 1050, and 1050.1. He is a founding member of the International Cell Line Authentication Committee. He is a generalist in the biomedical sciences, with a publication list spanning a wide range of areas in chemistry, carcinogenesis, biochemistry, pharmacology, toxicology, and virology.

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About The Author

Raymond Nims, PhD

Principal

Raymond Nims, PhD, is a consultant at Syner-G, joining in 2009. He brings over 49 years of experience in the biomedical sciences.
From 2006 to 2009, Ray served in Amgen’s corporate Quality Control group, providing subject matter expertise in viral and mycoplasma testing of raw materials and products, and serving as business process owner for Amgen’s global contract analytical testing lab outsourcing program. From 1994 to 2006, Ray directed laboratories at BioReliance performing viral safety, endotoxin, and cell line identity studies for biologics cell line characterization, raw material testing, and product lot release testing.

Raymond obtained a PhD in chemistry (chemical toxicology) at The American University, Washington, DC. He currently serves on the editorial board for the BioProcessing Journal and has served on the ad hoc advisory boards for USP chapters 1237, 1050, and 1050.1. He is a founding member of the International Cell Line Authentication Committee. He is a generalist in the biomedical sciences, with a publication list spanning a wide range of areas in chemistry, carcinogenesis, biochemistry, pharmacology, toxicology, and virology.

Read More Articles by Raymond Nims, PhD