For bacterial endotoxin testing, the world has relied for many years on a single source of lysate, the horseshoe crab. A significant change took place for the users of the European Pharmacopoeia on 1 January 2021 with the implementation of a new general chapter, 2.6.32. Test for bacterial endotoxins using recombinant factor C (rFc). This chapter, which uses a synthetic reagent, marks a significant step towards alleviating the need for animal resources when performing tests described in compendia.
This webinar is intended to support users and stakeholders with the swift implementation of the new general chapter by answering the following questions: What conditions need to be met? What needs to be verified? Is validation required? What needs to be done when using rFc instead of LAL? What is an alternative method in this context?
Duration: 40 minutes.
This webinar will be of interest to professionals from the pharmaceutical industry working in quality control, development, manufacturing and regulatory affairs.
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- Using recombinant factor C for bacterial endotoxin testing in the Ph. Eur. how far have we come, how far have we to go? by Emmanuelle Charton
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