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.

Editor's Top Tech November/December 2025
With the end of 2025 approaching, we have compiled a list of this quarters top tech. read more
The Whole Fleet Concept Design for Sterile Manufacturing of Biopharmaceuticals
In today’s rapidly evolving operational environments, the need for cohesive, integrated, and future-proof fleet strategies has never been greater. The Whole Fleet Concept Design represents a transformative approach to fleet planning, architecture, and lifecycle management – one that breaks traditional silos and enables a more unified, efficient, ... read more
An Interview with Timothy Cser and Lamin Jallow
We will see more robust automation technologies on the market to address the evolving expectations for QC microbiology. As regulations become more prescriptive, leaving less room for interpretation, and as manufacturing throughput becomes more crucial for newly marketed drugs, the expectation will be that automation can support these drivers rather... read more
Overcoming Data Barriers: How Cloud and SaaS are Transforming Life Sciences Manufacturing
Harnessing the full potential of data in pharmaceutical manufacturing can be complex for life sciences companies. Challenges include connecting systems, comparing data from sites with different systems, managing the volume, variety, and quality of information, overcoming data silos, and legacy technology. These all exacerbate interoperability, ... read more
An Interview with Ali Mroue and Jay Patel
“Traditional” methods are viewed as the gold standard, highly recognized, widely regulated, and backed by decades of acceptance, which leaves little external pressure to move away from them. On the other hand, adopting rapid methods requires significant investment in new technologies, extensive validation to meet regulatory expectations, and ... read more
Microbial Risk Management in Aseptic Processing - Did Bill Whyte Get it Right?
This commentary highlights how the advances in technology, risk assessment, and regulatory guidelines have excluded human intervention in aseptic filling, improving both product quality and patient safety. The risk of microbiological contamination during aseptic processing during the past four decades is largely a reflection of technological ... 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

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