The Art of Setting Biopharmaceutical Specifications – Release and Shelf-Life

Quality Control testing, coupled with the control over the manufacturing process, provides assurance of a biopharmaceutical's identity, purity, quality, potency, and safety. Each test method performed has an assigned limit, or range, or descriptor, referred to as specification. Specifications are required for release and shelf-life testing of the biopharmaceutical drug substance and drug product. In this chapter, the challenge of setting these specifications for biopharmaceuticals will be discussed – a challenge that should not be under-estimated. The need to apply the minimum CMC regulatory compliance continuum risk-based approach to specification assignments, from the start of clinical development through market approval, will be stressed. Regulatory guidance and industry practice on setting release and shelf-life specifications across the different types of biopharmaceuticals (protein-based, viral vectors and genetically modified patient cells) will be examined and compared.