In this Guide to Outsourcing & Testing, EPR explores trends in the pharmaceutical outsourcing market. Plus, Charles River discusses solutions for tracking, trending and microbial identification and Associates of Cape Cod International showcases its endotoxin testing capabilities.
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Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.
Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.
Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists. NCIMB’s Identification…
Technological innovations like automation and real-time analysis, as well as industry collaboration are anticipated to become key tools in the global microbial identification systems market going forward.
The study observed that using a modified vacuum filtration system assisted in the filtration of large volumes of bacterial cultures, removing the need for centrifuges.
How is the implementation of artificial intelligence, machine learning and virtual reality shaping the microbiology lab of the future? What do these innovations mean for personnel? Find out in this episode with AstraZeneca...
Product hub: How can CGT manufacturers ensure product safety with Microbial Solutions QC test methods?
Innovation forms the basis of every emerging technology. That is certainly the case with cell and gene therapies (CGTs), and the search for efficient quality control (QC) test methods continues to grow in this pharmaceutical sector. One of the most important factors to consider while deciding on a QC method…
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
Features in this in-depth focus explore the development of a sustainable approach to bacterial endotoxin testing (BET) within a global enterprise, as well as progress towards the use of biofluorescent particle counters for water bioburden applications.
Here, EPR presents a novel loop-mediated isothermal amplification (LAMP) assay developed to enable the rapid and sensitive detection of Burkholderia cepacia complex (BCC) in pharmaceutical manufacturing.
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
Read about bioMérieux's new system, 3P® ENTERPRISE - an end-to-end solution that fully digitalises and automates the EM process.
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…