Innovative Updates on 3Rs Initiatives and Opportunities in Regulatory Working Group
Discover the latest advancements in 3Rs initiatives within the DCVMN Regulatory Working Group, including successful case studies, project progress, and upcoming industry collaborations. Stay informed about the exciting developments shaping animal safety testing and regulatory processes.
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Presentation Transcript
3Rs Update DCVMN Regulatory Working Group June 18th, 2021 1
3Rs WG 3Rs WG - - Share case studies on successful 3Rs Share case studies on successful 3Rs implementation implementation Examples for Safety Tests Abnormal Toxicity Test, deletion of Specific Toxicity Test for Tetanus, deletion of the pertussis irreversibility test and replacement of HIST with CHO-cell assays Next Generation Sequencing (adventitious viruses/agents) Examples for Potency Tests Serological assays Single dilution SRID, RIA, etc. Antigen quantification In vitro relative potency test 2
3Rs WG and the PSPT wP Project 17 month Project sponsored by NIIMBL (started Sep 1, 2020). Consortium of 11 laboratories (3 NLCs, 7 DCVMN members, 1 manufacturer), 1 Research/service Provider Gantt Chart Month Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb International in-house assessment of the PSPT in mice to replace the intracerebral-challenge Mouse Protection Test (MPT) for whole-cell Pertussis (wP) Establish Consortium Definition of the Study Design Kick off meeting /Workshops Monthly technical workshops. Ad hoc Steering Group meetings. CMO Coating Antigen Production Characterization of the Coating Antigen Shipment of the Coating Antigen Technical Workshops Preparation for the testing phase Update @ Q2: preparation Coating antigen produced & characterized Shipment ongoing (delays due to COVID19): 7 completed, 2 in transit, 1 pending MTA signature DCVMN Data collection platform created and logins shared with labs 2 labs has started the testing phase Exploring options for future management of the remaining coating antigen:1800 vials to be equally distributed 1. DCVMN donation to a Centralized distributor (e. g., NIBSC) but maintenance and shipment costs to be foreseen for user labs 2. Donation to all wP manufacturers and NCLs of vials (ca. 30 labs globally, tbc) shipment covered by grant 3. Donation to an interested research lab (in case of negative outcomes from the study) Testing phase Data Collection (online platform) Statistical Analysis Reporting Final meeting (presentationof the 3
Updates on 3Rs initiatives & opportunities Updates on 3Rs initiatives & opportunities Abnormal Toxicity Test Animal Free Safety Assessment Collaboration + EFPIA plans half a day discussion with industry and regulatory stakeholders to speed up deletion of the test October 14th, 2021 at 12:30 CET. Invitation to DCVMN and all its members will come soon. Rabies replacement of NIH with ELISA EDQM/EPAA BSP148 phase 2 started protocol distributed, vaccines samples distribution 4
Updates on 3Rs initiatives & opportunities Updates on 3Rs initiatives & opportunities Polio Vaccines NGS to replace MAPRECT+Monkey NVT PATH is looking for interested manufacturers to join FDA/NIBSC phase 2 international collaborative study. If interested contact Kutub Mahmood - kmahmood@path.org HSI Working Group Accelerating 3Rs methods in vaccine testing in China Collaboration with Tsinghua University in regulatory requirements comparison Engagement of more industry and regulatory stakeholders. Interested? 5
Updates on 3Rs initiatives & opportunities Updates on 3Rs initiatives & opportunities NC3Rs: Reviewing animal use requirements in WHO biologics guidelines opportunities for the 3Rs https://nc3rs.org.uk/review- animal-use-requirements-who-biologics-guidelines Review of the TRS and General Recommendations work almost complete. Aim: propose new language introducing 3Rs approaches among the testing requirements. Survey to manufacturers and regulators will be shared soon. 11th World Congress On Alternatives And Animal Use In The Life Sciences 23 August - 2 September 2021 | Virtual Congress - https://www.wc11maastricht.org/ 6
Key 3Rs publications Key 3Rs publications Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay. https://doi.org/10.1016/j.biologicals.2021.04.002 Characterisation of diphtheria monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay. https://doi.org/10.1016/j.biologicals.2020.12.002 Variability of in vivo potency tests of Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccines. https://doi.org/10.1016/j.vaccine.2021.03.078 7
