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.

CIP Failures Due to Biofilm Formation: Strategies for Prevention and Remediation
The aim of a Clean-in-Place (CIP) system is to remove all undesirable materials from product contact surfaces to a level such that residues remaining are of minimal risk to the safety or quality of the product. While the general focus is on the removal of product residues or chemical residues, there is often a microbial control element involved. ... read more
Pharmaceutical P.I.N. Points: Patent Innovation News
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in December, 2024. 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

Validating Automated Alternative Rapid Sterility Methods
This webinar will provide an overview of the on-site validation approach used by Rapid Micro Biosystems™ to demonstrate that the Growth Direct® Rapid Sterility System, is equivalent or non-inferior, to the compendial sterility test described in the ... read more
Engineering for equivalency: Building reliable, optimized facilities
As biomanufacturing grows more complex, the need for facilities that deliver both speed and reliability has never been greater. In this webinar, you will learn how Samsung Biologics' optimized manufacturing framework and a centralized design ... read more