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.

Goodbye Rabbit, Hello MAT: The Start of a New Era in Pyrogen Testing
In June 2024, the European Pharmacopoeia Commission adopted 57 revised monographs from which the rabbit pyrogen test (RPT) was deleted, and it added a new general chapter 5.1.13 on pyrogenicity. read more
Mesenchymal Stem Cells Are Leading the Future of Regenerative Medicine
Stem cell therapies are transforming the approach to degenerative diseases like osteoarthritis, cardiovascular disease, chronic lung disease, Alzheimer’s, and Parkinson’s. Among the many stem cell types currently being explored for this application, mesenchymal stem cells (MSCs) have demonstrated a significant therapeutic advantage. 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 March 2025. read more
Sharper, Faster, Smarter: The Mass Spectrometry Advantage in Bioanalytical Testing
Drug-plasma protein binding is a fundamental parameter in drug development that directly affects how a compound is distributed, metabolized, and excreted. Only a drug’s unbound fraction is pharmacologically active, so accurate measurements are essential for understanding efficacy and safety. This information also guides dosage design, predicts ... read more
Spray Dried Dispersions in Controlled Release Formulations
The pharmaceutical industry continues to face significant challenges in formulating poorly water-soluble drugs, which constitute most new chemical entities (NCEs).1 Among various solubility-enhancing strategies, amorphous solid dispersion (ASD) is one of the most effective and versatile strategies for enhancing oral bioavailability. ASDs can ... read more
Analytical Method Development with a Practical Risk Assessment Program that Enhances Commercial QC Robustness
Active pharmaceutical ingredient process development requires comprehensive analytical controls utilizing a wide range of analytical methods. An analytical risk survey program was previously developed to evaluate common risk factors in the analytical control strategy for early to mid-stage development. For late-stage and the development of ... read more

eBook: Digital Sensor Technology for Real-time Diagnostics in Bioprocessing
This eBook covers a wide range of topics detailing the technologies and benefits of using digital sensors for bioprocessing applications. Specific topics covered include: reasons to switch to ISM sensors; benefits of upgrading to digital tech; oxygen measurement in fermentation and cell culture; oxygen control in bioreactors; ... read more
eBook: Your Guide to Environmental Monitoring for Aseptic Processing
This eBook covers a range of topics worth considering when implementing or using an environmental monitoring system for aseptic processing applications. read more
Analyses of Antibody Drugs Using Inert Ultra High Performance Liquid Chromatography
This article introduces analyses of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) for quality control using an inert UHPLC system that is extremely resistant to mobile phases containing high salt concentrations. By suppressing the interaction between antibody drugs and stationary phase, the system delivered ... read more
Whitepaper: Key Considerations for Extracting Proteins from Recombinant Host Cells
In the biopharmaceutical industry, quality is pivotal. For a final product to meet quality standards, quality must be built into the production process. Biopharmaceuticals, however, are made from biologically sourced materials, which are inherently variable. read more
Whitepaper: QC Executive Q&A - Research and Development of Protein-Based Therapeutics
As a global provider, MilliporeSigma offers a wide range of products and services to biopharma. On the analytical side, we have a growing selection of chromatography and sample preparation products for development and QC laboratories. 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