Articles
Reducing Microbial Contamination Risk In Biotherapeutic Manufacturing
March 26, 2010
•Article: Reducing Microbial Contamination Risk In Biotherapeutic Manufacturing
By Christopher J. Mach and Donna Riedman
The risk of contamination (especially microbiological) is always an area for special attention in biopharmaceutical processes. No matter the process stage, whether upstream of a bioreactor or in the final filling of a sterile product, effective contamination control continues to be a critical requirement, so any opportunities for improvement may justify further investigation. Even with established validated processes, demands for higher purity and increased sterility assurance may require manufacturers to reassess their procedures and technologies. New processes present an even greater opportunity to introduce innovative, enhanced technologies that can improve contamination control to satisfy regulatory requirements not only today but in the foreseeable future.
Reprinted with permission from BioProcess International
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