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.

  • Microbial Risk Management in Aseptic Processing - Did Bill Whyte Get it Right?

    This commentary highlights how the advances in technology, risk assessment, and regulatory guidelines have excluded human intervention in aseptic filling, improving both product quality and patient safety. The risk of microbiological contamination during aseptic processing during the past four decades is largely a reflection of technological ... read more

  • Recent Advances in Pharmaceutical Microbiology and Ongoing Challenges

    Pharmaceutical microbiology is a rapidly evolving discipline that plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products. The last few years have witnessed significant innovations in techniques and methods, often driven by the need for faster drug development, stricter regulatory requirements, and the ... read more

  • Recombinant Lysate Manufacture: Considerations for Contamination Control

    Pyrogens in general (including lipoteichoic acids, CpG DNA, viruses, and flagellin), and Gram-negative bacteria that release endotoxin, present a risk for pharmaceutical products that are administered in ways that bypass the body’s natural defenses, especially those that are infused into the bloodstream. This concern exists since endotoxin ... read more

  • Microbiology Roundtable

    Don Singer, Senior Global Microbiology Consultant, New Beginnings Microbiology: It has been almost two decades since quality systems have been designed, implemented, and been on a continuous improvement path, while technology and validation in microbiology have taken a slightly different and more constrained path. read more

  • An Interview with Estelle Alvergnas

    Pyrogens are contaminant substances in injectable drugs or implants that can provoke harmful reactions in patients, ranging from mild fever to severe, potentially life-endangering symptoms. Among the various pyrogens, endotoxins—lipopolysaccharides of gram-negative bacteria—are the most commonly found in pharmaceutical products. All other pyrogens ... read more

  • EMA’s Annex 1: Lead, Follow or Get Out of the Way

    EMA’s Annex 1 Manufacture of Sterile Medicinal Products includes expectations for the manufacture of sterile products.1 However, the Annex essentially equates the performance of different aseptic technologies which has the effect of slowing the implementation of advanced aseptic technologies that support improvements in product/patient safety. ... read more
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Documentary

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