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Expert view: Improving the endotoxin test paradigm established by LAL

21 April 2020 | By

THE ADVANTAGES of the recombinant Factor C (rFC) test lie in its (a) scientific characterisation, (b) sustainability and (c) specificity. In light of diminishing horseshoe crab populations, sustainability has been mandated via regulations that include the concept of the “3 Rs”: replacement, reduction and refinement of analytical tests and reagents…

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Eurofins BioPharma Product Testing

10 May 2019 | By

From starting materials through to finished product testing, Eurofins BioPharma Product Testing’s 34 facilities in 17 countries deliver a comprehensive scope of harmonised GMP testing services and seamless regulatory acceptance.

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Charles River microbial solutions

8 May 2019 | By

Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…

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Expert View: Advancing bacterial endotoxin testing with recombinant Factor C

7 May 2019 | By

Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.