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.

An Interview with Lamin Jallow
The main difference is the level of detail in the new USP 73. As a chapter with a two-digit number, it contains some methodology and details that were missing in the original publication. For instance, it contains an equation to calculate the incubation time before ATP bioluminescence detection is performed. read more
Mechanistic Modeling: Biotechnology Manufacturing
Mechanistic modeling in biotechnology refers to the development of models based on the underlying biological, chemical, and physical processes that govern cellular behavior, enzyme kinetics, metabolic pathways, and bioreactor systems. These models are crucial in understanding and optimizing processes in biotechnology, from the design of bioreactors... read more
Emerging Roles of Nucleic Acid-Based Methods in Pharmaceutical Microbiology
New technologies based on the detection and sequencing of nucleic acids are emerging rapidly leading to questions about their best applications, validation requirements, limitations, cost, and implementation. Although the focus of this commentary is largely on pharmaceutical microbiology the status of nucleic acid-based methods in environmental, ... read more
Comparing an Inspection by a Regulator to an Investigation by a Pharma Company
Recently, there has been an increased focus on contamination control activities for pharmaceuticals due to updated requirements in the European Union’s Annex 1 Update. (EU, 2022). The recent update of Annex 1 (ISO 14644-1, 2022) has specified the need for a contamination control strategy for both sterile and non-sterile products. Recently, a ... read more
Comparison of Optical Spectroscopy Techniques for Pharmaceutical Analysis
The optical spectroscopy toolbox contains a large variety of methods that exploit light-matter interactions such as absorption, emission, and scattering phenomena across the entire electromagnetic spectrum. This work aims at giving an overview of the available techniques and their potential applications for product and process analysis in the ... read more
Cyber-Physical Trust Platforms: A Cornerstone Technology in Pharma’s Digital Transformation
In the pharmaceutical and life sciences sectors we are beginning to see how novel technologies, such as Machine-to-Machine (M2M) communication, Artificial Intelligence (AI), and the Industrial Internet of Things (IIoT) can play a role fostering innovation, improving product authentication, and transforming traditional operational models. 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