Protein Therapeutics and the Regulation of Quality: A Brief History - As the biotechnology industry has matured through various stages of growth, regulatory agencies have evolved in response to the ne

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Protein Therapeutics and the Regulation of Quality: A Brief History
As the biotechnology industry has matured through various stages of growth, regulatory agencies have evolved in response to the need to define quality standards.


BioPharm International
Volume 20, Issue 10

Over the last two decades, biotechnology has moved from a source of fear to a source of benefit,even outside the pharmaceutical arena. Despite a 1978 Hollywood depiction of killer tomatoes, in 1993 a genetically engineered tomato was approved—and life went on. However, some uncertainties in biotechnology still exist, and both the industry and the agency must be ready to take advantage of new opportunities and to respond to new challenges. OBP and its staff, both as regulators and consumers, look forward to the next two decades of biotechnology.

DISCLAIMER

Products mentioned in this article were chosen to illustrate developments in product design, manufacturing, or dosage form. In some cases clinical indication or other attributes were noted. No endorsement or judgment beyond product labeling on these or other products should be inferred.

ACKNOWLEDGEMENTS

Keith Webber, Elizabeth (Wendy) Shores, and Patrick Swann provided valuable comments on this manuscript.

SOURCES

Sources for information in this article include the following:

1. FDA and OBP staff.

2. FDA's web site, http://www.fda.gov/.

3. US Food and Drug Administration. Science and the regulation of biological products, 2002. Rockville, MD.

4. Walsh G. Biopharmaceutical benchmarks 2006. Nat Biotechnol. 2006 Jul;24(7):769 –76.

5. Product package inserts.

6. BIO web site, http://www.bio.org/.

Steven Kozlowski, MD, is the director of the Office of Biotechnology Products in the Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, 301.796.2390,
.


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