The EDQM, in collaboration with the EPAA and JRC, organised a virtual workshop (webinar sessions) on ‘Novel in vitro model as alternative to in vivo toxoid vaccines testing: Clostridium septicum vaccine as a proof of concept’.
The webinars aim to facilitate the implementation of the new in vitro cell-based assays for in-process quality control, validated through collaborative study BSP130 – a joint EDQM-EPAA project successfully completed in 2018. The webinars discuss study results and share practical experience and knowledge of these new methods with participants.
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Target audience
These webinars are of particular interest to those working in vaccine manufacture and/or involved in the control and licencing of vaccines for veterinary use.
Workshop Webinar 1: Introduction & Sessions 1-3
This webinar gives an overview of the activities of the EDQM, the EPAA and the JRC EURL ECVAM in the field of 3Rs. There are presentations on the study aims and results of the Clostridium Vaccine Project (BSP130) as well as the outcome of a field survey carried out on Clostridium Vaccines Control.
Duration: 4 hours.
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- EDQM Activities in the field of 3Rs, by Catherine Lang
- EPAA activities in the field of 3Rs, by Irene Manou
- EURL ECVAM activities in the field of 3Rs, by Marlies Halder
- The BSP Programme, by Catherine Milne
- Outline of BSP130 Part 1, by Keith Redhead
- Method optimisation and their principles, by Balazs Dalmadi
- Statistics, by David Le Tallec
- Results Overview, by Botond Siklodi
- Feedback from BSP130 participants, by Marie-Emmanuelle Behr-Gross and Catrina Stirling
Workshop Webinar 2: Session 4, 5 & the Concluding Session
This webinar focuses on the proposals being made for European Pharmacopoeia monographs, as well as feedback from industry and regulators. This is followed by presentations considering the potential application of the Approach to other Toxoid Vaccines and a summary of the workshop discussions.
Duration: 3 hours, 50 minutes.
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- Achievements and issues for Ph. Eur. Group of experts 15V, by Lukas Bruckner
- Feedback from industry and way forward, by David John
- Regulators’ perspective from Europe, by Esther Werner
- Regulators’ perspective from the USA, by Angela Walker
- Experience in extending the approach of cell-based TCP and MLD assays, by Arjen Sloots
- Perspectives for extending the approach to other toxoid vaccines, by Mohammad Daas
