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Regulatory Focus™ > News Articles > Biologics and Manufacturing Changes

Biologics and Manufacturing Changes

Posted 01 February 2011 | By Richard M. Lewis, PhDMary Ellen Cosenza, PhD, RAC

Historically, biological products were defined by the process that produced them. Biochemical methods were inefficient in defining a "wellcharacterized" material, so the manufacturing methods themselves were tightly controlled to ensure the production of a product consistent with the one used throughout clinical trials and demonstrated to be safe and effective. By definition, this implied that a change in the process might also change the product. Although biological products have become much better characterized over the last couple of decades, the manufacturing process is still an important component in defining the product.


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