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.

Implementation of Contamination Control Strategy: Regulatory Evolution and Industry Adaptation Since 2023
The implementation of Contamination Control Strategy (CCS) under the revised EU GMP Annex 1 has fundamentally transformed how pharmaceutical manufacturers approach sterile drug production. Since the guidelines became effective on August 25, 2023, the industry has grappled with translating theoretical regulatory requirements into practical ... read more
The Critical Role of Diagnostics in Antimicrobial Stewardship
Antimicrobial resistance (AMR) is a pressing global health challenge. While much of the discussion is focused on future implications, resistant infections are already having a profound impact. In 2019, bacterial AMR was directly responsible for an estimated 1.27 million deaths worldwide - more than HIV/AIDs or malaria.. The actions we take today ... read more
An Interview with Lamin Jallow
The main difference is the level of detail in the new USP 73. As a chapter with a two-digit number, it contains some methodology and details that were missing in the original publication. For instance, it contains an equation to calculate the incubation time before ATP bioluminescence detection is performed. read more

Pneumococcal polysaccharides – Advancing research and development
Carbohydrates in the form of capsular polysaccharides and lipopolysaccharides constitute a major component of the cellular surface for many bacterial species1. In Streptococcus pneumoniae, capsular polysaccharides function as major virulence factors that protect the bacterium from phagocytosis by host immune cells. Within this ... read more
Risk Assessment for a Rapid Mycoplasma Test Optimized for Cell Therapy Products
Risk assessment is a valuable tool for selection and optimization of rapid mycoplasma testing methods. Mycoplasma testing is a requirement at various stages in the production process for cell therapy products. Standard methods take at least 28 days and are not appropriate lot release tests for products with short shelf-lives. A ... read more
Milliflex® Quantum – Detection of microbial contaminants in water samples
Water is a key raw material utilized in the manufacturing of products within the pharmaceutical, biopharmaceutical and healthcare industries. Within each industry, regulatory requirements exist for microbial contamination in different levels of water purity. The microorganisms found in these water systems are mainly stressed, ... read more
Control over your microbial identification using the gold-standard genotypic method from Life Technologies
Eliminate your outsourcing needs! Gain visibility and control. Learn how the next-generation, high-throughput MicroSEQ® system delivers right-first-time accuracy and give you complete control over microbial identification, by owning the system, the process and data analysis. read more

Clean Facility of the Future: Advanced Microbiology Technologies for Cleaner Facilities and Purer Products
As the industry becomes more focused on bringing biopharmaceuticals to market the pressure to increase production, decrease costs and ensure the highest quality and safety for finished products becomes greater and greater. And ... read more

On-Demand Webinar: Rapid Sterility Testing as the Critical and Final Result for Product Release
In this webinar, hear from Eric Chenelle, Product Manager from Rapid Micro, as he discusses Rapid Sterility Testing as the Critical and Final Result for Product Release. read more
Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products
Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and error in the Clean Facility of the Future Documentary. read more