Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities

Improving in vivo assays in snake venom and antivenom research: A community discussion

“…However, regulators and manufacturers are committed (and bound by relevant national legislation) to implementing the 3Rs, which many examples of improved methodology have been adopted by pharmacopoeias in the recent past, most notably for biologics. 67,68 This is reflected by some antivenom manufacturers actively investigating alternative efficacy models, including in vitro and non-regulated in vivo modes, for product release due to the ethical challenges and costs associated with conventional ED 50 testing. Examples include the ongoing development of an embryonated egg model for testing by Seqirus, [69][70][71] and approval in recent years of antivenomics (immunoaffinity chromatography) techniques for product release by a national regulator, 72 and as screening test for antivenom efficacy before proceeding into mouse assays.…”