Origins of the initiative

In 1996 the US Food and Drug Administration recognised that the process for granting licences for biological products had specialized requirements that were not well served by the licensure process for small molecule chemical therapeutics. This led to The FDA Centre for Biologics Evaluation and Research (CBER) initiating the term 'Well Characterized Biological Product'. The analysis of the clinically active component of a large, complex biological product required methods that were more demanding than those for small molecule chemical substances. In addition, their manufacturing processes often define the properties of the biological drug substances. Changes in the manufacturing process, equipment or facilities have been recorded as resulting in changes in the biological product, to the extent where there have been cases of FDA requesting additional clinical studies to demonstrate the product's continuing safety, identity, purity and potency.

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