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Your endotoxin experts
The future of sustainable LAL testing has arrived with ACC’s PyroSmart NextGen recombinant LAL reagent technology for bacterial endotoxin testing (BET).
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Endotoxin
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Application note: A new, more flexible endotoxin test platform
This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.
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Guide to Outsourcing
Welcome to European Pharmaceutical Review’s Guide to Outsourcing. In this edition, Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA) reflects on the fortunes and challenges of the CDMO sector, highlighting their invaluable place in today’s drug development strategies, and Associates of Cape Cod and Charles River showcase…
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Case study: Delivering a world class cell and gene therapy suite
RoslinCT and Connect 2 Cleanrooms have worked in partnership to deliver a world-class cell and gene therapy facility.
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QA/QC & Environmental Monitoring In-Depth Focus 2021
In this in-depth focus, learn how to overcome interfering factors when using LAL for endotoxin testing and discover how the implementation of a new scrubs system benefited an aseptic production facility.
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Bacterial Endotoxin Test using LAL methodology: overcoming interfering factors
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
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European Pharmaceutical Review Issue 4 2021
In our latest issue, features explore the use of nano formulations to improve skin and nail drug delivery, how to take cell and gene therapies from concept to commercialisation and what strategies you can use to overcome interfering factors in LAL bacterial endotoxin testing. Also in this journal, find out…
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Worksheet: ARMM technology comparison
This worksheet can be edited to include specifications discovered during your evaluation of Alternative Rapid Microbiological Method Technologies.
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Whitepaper: How digital modelling supports cleanroom design
In this whitepaper, C2C’s Product & Process Development Lead explains how using digital modelling in the design process can guarantee results.
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On-demand webinar: The art of changing QC testing methods
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
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Application note: The Monocyte Activation Assay: The benefits of an animal-free test to show pyrogen-free pharmaceutical products
Fever is something that most of us have experienced. However, when we use medicines or medical devices, we expect them to improve our health – not to cause a fever.
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Infographic: Simplified bacterial endotoxin testing
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
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Video: BET automation is easy and simple with microfluidics
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
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On-demand webinar: Celsis® for sterility – product spotlight
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
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Infographic: How different endotoxin testing platforms work
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
