Whitepaper: rFC adoption for bacterial endotoxin testing
What is driving the adoption of rFC for BET? Alternative methods are the obvious sustainable solution for efficient manufacturing.
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What is driving the adoption of rFC for BET? Alternative methods are the obvious sustainable solution for efficient manufacturing.
What’s new in the cell and gene therapy landscape? What is the role of quality control in efforts to scale up manufacturing of CGT products and alleviate talent constraints? Find out more in this podcast with bioMérieux…
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.
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.
As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions like rFC.
A new age of sustainability: discover how ACC’s PyroSmart NextGen® recombinant Cascade Reagent (rCR) enhances bacterial endotoxin testing (BET).
Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
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…
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
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.
Why do pharmaceutical manufacturers still believe older methods are reliable for quality testing when there’s superior technology available on the market?
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
Single use technologies is highly booming in biopharmaceutical sector due to its efficient use and benefits.
The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System) provides more sensitive detection of non-endotoxin pyrogen contaminants in pharmaceutical preparations.