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.

Introduction to End-to End Integrated Continuous Biomanufacturing
End-to-end (E2E) continuous biomanufacturing refers to the integrated, uninterrupted process for producing biologics, such as monoclonal antibodies, vaccines, and enzymes, directly from raw materials to the final product. This system contrasts with traditional batch processes that have discrete stages, starting and stopping for each batch. read more
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

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: Advantages of Antibody-based Selectivity in the Purification of Next Generation Biologics
It has been almost 40 years since the first biologic drug reached the market. That drug was human insulin, which was produced by cloning human genes into E. coli for protein expression at a scale suitable for therapeutic use. read more
eBook: Optimizing Your Biopharmaceutical Processes
eBook offers a complete guide to ensure your biopharmaceutical process produces the highest quality product as efficiently as possible. 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

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