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The US Food and Drug Administration did not approve any biologically derived products between 1975 and 1982. Between 1982 and 1990, there was an average of two product approvals per year. To reverse this trend, an increased focus was placed on development and clinical trial activities resulting in a tremendous increase in FDA approvals.
From 1991 to 1995, the average approval rate was three products per year, and since then, the approval rate has increased to more than 15 products per year. Parsons expects that in the coming years, more than 50% of therapeutic products will come from biological sources.
The International Society for Pharmaceutical Engineering (ISPE) is in the process of finalizing the Baseline® Guides for Biologics. This guideline is intended to guide the industry in the design, construction, and validation of biological facilities. The basic GMP requirements are still governed by the FDA regulations and guidelines; however, the ISPE guideline will supplement and interpret FDA requirements in engineering terms.
As the biotechnology industry has matured, so has the FDA's treatment of "well characterized" products. Since most biologic products are made by methods that are not as precise as that in chemical synthesis, the FDA has always been very leery of any change in process, equipment, or manufacturing location. This has stifled innovation and efficiency improvement because the FDA has always required rigorous proof that manufacturing changes have not altered the product in any way. The FDA has agreed to treat some "well characterized" biologics that have been on the market for a long time similar to drugs, particularly small molecule biologics, allowing for flexibility in design. These changes have been positive for the industry: total design, construction, validation, and product delivery time have been reduced.
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