Biologic License Establishment

As a part of the FDA Modernization Act, passed in 1997, the regulatory agency has combined the Establishment License Application (ELA) and the Product License Application (PLA) into one package called the Biologic License Application (BLA) (Table 2.1 in Chapter 2). While this change has streamlined the new drug licensing process, the FDA still tightly regulates manufacturing facilities engaged in the production of biotechnology products. The FDA no longer strictly defines the biotechnology product by using the idea of "the process is the product," because a number of analytical tools that allow improved characterization of the product and of biological contaminants are now available. As a result of these changes, recombinant proteins can be manufactured in multiple facilities so long as each facility provides assurance of product quality. In the BLA process, a new manufacturing establishment may obtain a site license at the time of certification of the first batch of product manufactured in that establishment.

The manufacturing facility or establishment must file a detailed flow diagram that includes the flow of raw materials to areas allocated for storage, holding, mixing, manufacturing, purification, testing, and final release. All manufacturing must adhere to current Good Manufacturing Practice (cGMP) guidelines as briefly presented in Box 4.6. If more than one product is manufactured in the same facility, a comprehensive list of all the products manufactured in the establishment must be disclosed. Under the previous PLA/ELA dual application process, a biotechnology company was required to identify a facility to manufacture "one dedicated product."

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