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

White Paper: Versatile and Highly Accurate Microbial Identification For Labs of All Sizes
Bacterial and fungal contamination of raw materials, processing facilities, or finished products can have an enormous negative impact on biopharmaceutical manufacturers. Pharmaceutical companies, medical device makers, public health labs, and contract manufacturing organizations (CMOs) need accurate and fast microbial ... read more
White Paper: Successfully Implementing Rapid Microbial Methods for Mycoplasma Detection
For the last several years, Bionique Testing Laboratories has been in a unique position to facilitate the adoption of rapid mycoplasma testing strategies by their clients. Predominantly cell therapy developers motivated by particularly short production schedules and product shelf life, this pool of clients has grown to include ... read more
White paper: Making the Switch to In-House Mycoplasma Testing
Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines state that recombinant bulk harvest must be tested for mycoplasma prior to further processing. read more
White Paper: Validation Guidance for Residual Host Cell DNA Testing of Biologics
Assurance of product safety and quality are top of mind for all biotherapeutic manufacturers read more
eBook: Lipid Technologies: Helping to Develop the Next Generation of Pharmaceuticals
The FDA recently issued guidance intended to curtail the use of medically important antibiotics in agricultural applications. 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