Quality Control Issues Related to Biological Products: Microbial Contamination
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Quality Control Issues Related to Biological Products: Microbial Contamination King C. Lee and Leyla Toksoy Drug Information Journal 2002 36: 631 DOI: 10.1177/009286150203600317 The online version of this article can be found at: http://dij.sagepub.com/content/36/3/631
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Drug Infonnalioii Journal, Vol. 36. pp. 631-634, 2002 Primed in !he USA. All rights reserved.
0092-8615/2002 Copyright 0 2002
Drug Information Association Inc.
QUALITY CONTROL ISSUES RELATED TO BIOLOGICAL PRODUCTS: MICROBIAL CONTAMINATION KINGC . LEE, PHD, RAC Executive Director. Regulatory Affairs, Aton Pharrna, Inc., Tarrytown, New York
LEYLATOKSOY Associate Director. Quality Assurance. Vion Pharmaceuticals, Inc.. New Haven, Connecticut
This article describes the source, methods of detection, and methods of elimination of microbial contamination. The three possible origins of microbial contaminants are: cross, environmental, and commonly-knonn microbial contaminants. Many tests can be used to detect microbial contamination; however; some should be nrodifed to allow sensitive detection of microbial contamination in the presence of a large quantity of biological products. To avoid microbial contamination, institute features in the faciliiy design ro control contamination; dedicate equipment and the production suite to the specific biological product; use a Class 100 laminar flow hood for the downstream production process; sterilize all equipment, growth medium, and packing materials; conduct integrit?,testing of the sterilization filters before and after production; perform in-process controls to prevent or identifi contaminants; and monitor the environment and personnel. Key Words: Quality control; Biological products; Microbiological contamination
INTRODUCTION THE USE OF MICRO-ORGANISMS, especially those that have undergone genetic modification(s), has expanding biopharmaceutical applications such as vaccines, gene therapy, and therapies for diseases including cancer, metabolic diseases, cardiovascular diseases, pulmonary diseases, and so forth. Accordingly, the number of biological products being produced has been increasing exponentially. For nonbiological products, microbial contamination can normally be detected by the traditional culturing, bioburden, or other techniques, and can normally be
Reprint address: King C. Lee, PhD, RAC, Executive Director. Regulatory Affairs, Aton Pharma. Inc.. 777 Old Saw Mill River Road, Suite 205. Tarrytown. NY 10591 (e-rnail: klee8atonpharma.mi8.corn).
eliminated by traditional sterilizati
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