Microbiology

Pharmaceutical microbiology plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products. Modern instruments deliver sensitive, reliable solutions to support microbiologists across the full spectrum of workflows. These innovations help pharmaceutical manufacturers ensure compliance while maintaining efficiency and patient safety. In this hub, explore articles, webinars, and other informative resources related to pharmaceutical microbiology.

  • Using Rapid Microbiological Methods Flexibly to Ensure Safe Cell and Gene Therapeutics

    Testing short-life cell and gene therapeutics for microbiological contamination is a challenge because they usually need to be administered before the result of a compendial sterility test becomes available. This is why manufacturers are implementing alternative rapid methods that take only a fraction of the time. Estelle Alvergnas and Lamin Jallow... read more

  • Viral Vector Process Development and Manufacturing

    The field of clinical gene therapy has advanced rapidly and now accounts for over 2,200 clinical trials initiated since 1989, of which ~65% are being conducted in the USA. Progress in the field has contributed to a new generation of gene therapy commercial initiatives, including several startup companies. Since the beginning of 2013, at least $600 ... read more

  • Lack of Utility of the USP Tests for Specified Microorganisms

    During my consulting practice, I get many requests from clients to evaluate non-target bacteria isolated during tests for specified microorganisms. Although I appreciate the business, these requests highlight a serious shortcoming in pharmaceutical microbial release testing. USP <1111> Microbiological Examination of Non-sterile Drug Products: Acceptance ... read more
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