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.

Penetrating Sterilization
Sterilization is critical to patient safety and application, but it must always be balanced with utility. There is no perfect method suitable for every need. read more
The Application of Manufacturing Management Systems to Aseptic Filling Operations and Pharmaceutical Water Systems
Advanced statistical processing identifies excursions outside the alert and action levels as well as in response to a loss of environmental control. read more
Unlocking Productivity: How Advanced Technologies Are Transforming Microbial Quality Control in Pharma
Pharmaceutical manufacturers are facing a perfect storm of challenges. Aging populations in advanced economies are shrinking the pool of qualified laboratory personnel, while the volume and complexity of quality control (QC) testing is growing—especially with the rise of biologics and advanced therapies. read more
Lifting the Lid on Biopharmaceutical Manufacturing: Unlocking New Possibilities in Media and Buffer Preparation
The biopharmaceutical industry faces ongoing pressure to deliver new therapies to patients as quickly and efficiently as possible. To accomplish this, manufacturers need to develop and optimize cost-effective production processes without compromising quality or safety. read more
Ensuring Excellence in Pharmaceutical Water Systems - Points to Consider
Water plays a critical role across the pharmaceutical industry—as a raw material, inactive ingredient, processing aid, and vehicle for medicinal products. It is essential in the formulation and manufacture of dosage forms, active pharmaceutical ingredients (APIs), API intermediates, compendial articles, analytical reagents, and cleaning processes. read more
Rethinking Shewhart Control Charts for High-Frequency Automated Data in Biopharmaceutical Manufacturing
High-frequency automated process data in modern biopharmaceutical manufacturing provide unparalleled visibility but also present new challenges for process monitoring. 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
White Paper: Validation of a Duplex qPCR Assay to Detect Residual Sf9 Host Cell DNA and Baculovirus DNA
Current regulatory authorities (WHO, EMA and US FDA) limited the accepted amounts of residual DNA in biological products making it extremely important to have a sensitive method of quantifying residual host cell DNA. read more
eBook: Slope Spectroscopy Method
The SoloVPE System is an innovative instrument for the UV-VIS-NIR spectroscopy. read more
Rapid Mycoplasma Testing Service Delivers Speed, Sensitivity and Specificity to a Broad Scope of Sample Matrices
Mycoplasmas are the smallest known selfreplicating prokaryotes. They parasitize a wide range of host organisms, including humans, animals, plants and insects and are common contaminants of mammalian cell culture. read more
The Process of Pharmaceutical Elastomer Selection for Injectable Biologics
Even before the current pandemic laser-focused the pharmaceutical industry’s attention on achieving a coronavirus vaccine, the spotlight on injectable drugs was bright thanks to the accelerating innovation in delivery devices and the rise of chronic diseases. According to ReportLinker’s report “Injectable Drug Delivery Devices ... 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

Improving Environmental Monitoring Sampling Workflows Through Paperless Operations
Paperless sampling operations offer opportunities for more standardized documentation practices and streamlined EM workflows, improving documentation management, transcription accuracy, process visibility, and review efficiency over traditional paper... read more
Cleaning & Disinfection in Biopharma: Cutting Contamination Risk
As biopharmaceutical processes become more biologically complex and operationally interconnected, the impact of contamination events continues to grow. Cell and gene therapies, multiproduct facilities, single-use systems and accelerated timelines ... read more
Implementation of Global Microbiology QC Automation at Amgen
In this webinar learn how Amgen transformed its global QC Microbiology operations by implementing the Growth Direct® platform to fully automate in-process bioburden, water bioburden, and environmental monitoring testing. read more