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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…
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…
This worksheet can be edited to include specifications discovered during your evaluation of Alternative Rapid Microbiological Method Technologies.
In this whitepaper, C2C’s Product & Process Development Lead explains how using digital modelling in the design process can guarantee results.
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.
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.
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.
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.
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
Automated endotoxin testing is achieved in a compact platform, leveraging microfluidic liquid handling. QC labs simplify BET with easier, compliant assays using less LAL.
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Associates of Cape Cod Intl Inc., Nelson Labs and SGS Health Science showcase their unique testing services and discuss how they stand out from the competition.
ACCI has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years and has grown to be an internationally recognised leader in endotoxin detection. Find out why they should be your choice in of endotoxin experts in this guide.
Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
