The workshop will be recorded. A workshop report will be published
The online workshop is part of the Humane Society International (HSI) Project “Accelerate non-animal batch release testing for human vaccines”[1] funded by the Bill & Melinda Gates Foundation and part of the AFSA Biologicals workstream activities.
The workshop follows the EDQM/EPAA event held in February 2023 “The future of pyrogenicity testing. Phasing out the rabbit pyrogen test”[2], the NC3Rs Report on to WHO ECBS[3], and HSI’s bilateral conversations held across 2023 with industry and regulatory stakeholders on the topic.
Objectives:
1) the workshop aims to provide an overview of the activities and projects currently ongoing at a global and local level to implement the Monocyte Activation Test as replacement of the Rabbit Pyrogenicity Test for biological products
2) it is a platform for the various stakeholders to have a practical exchange on the different MAT approaches, their products specificity, the associated challenges and implemented solutions
3) it allows participants to interact with key experts in the field
4) understand how the phasing out of the Rabbit Pyrogenicity Test might look like in local, regional and global context
Scientific Organizing Committee
- MHRA, UK: Paul Stickings, Caroline Vipond, Trusha Desai, Kata Dix
- ISS, Italy: Marilena P. Etna, Eliana M. Coccia
- PEI, Germany: Ingo Spreitzer
- Institute of Biological Products, Thailand: Wipawee Wongchana
- GSK, Germany: Shahjahan Shaids
- Sanofi, France: Emmanuelle Coppens
- Butantan Foundation, Brazil: Juliana Galvão
Targeted Products: vaccines, antisera, antivenom, blood derived products (no medical devices)
Target Audience: regulators and assessors, pharmacopoeias’ experts and committees, national control laboratories, international organizations, vaccine manufacturers and associations.
PRE-REGISTRATION SURVEY: Your feedback will provide information to the workshop’s organizers and speakers about the experience and challenges on the implementation of the MAT and will be used to define the topics to discuss during the final roundtable discussion. The survey data is collected anonymously. Please fill out the survey here: https://app.sli.do/event/1tcfug3EyXgLmGXvvfdFDN
AGENDA
| Time in CEST | Topic | Speaker |
| 12:00 – 12:10 | Welcome and meeting objectives | Laura Viviani, SciEthiQ on behalf of AFSA |
| 12:10 – 12:30 (15+5) | Development/use of assay controls for the MAT -> MHRA/WHO/EDQM project – how to use the non endotoxin reagents | Caroline Vipond, MHRA |
| 2 hours | Blood Derived Products Chair: Laura Viviani | |
| 12:30-12:50 (15+5) | Development of MAT for blood derived products in South Korea | Dr. Hang-sik No Senior Scientific Officer, Blood Products Division, National Institute of Food and Drug Safety Evaluation Dr. Boksik Cha, Ph.D. Chief / Senior Researcher Team for Safety Assessment New Drug Development Center, Daegu-Gyeongbuk Medical Innovation Foundation |
| 12:50-13:10 (15+5) | Implementation of MAT in the antisera produced in Brazil. | Debora Ferrarin, QC Analyst, Butantan Foundation, Brazil |
| 13:10-13:30 (15+5) | The Cuban Experience with the MAT Pyrogenicity Test on Parenteral Human Serum Albumin | Rolando Perdomo Morales, Center for Pharmaceuticals Research and Development (CEDEM), Cuba |
| 13:30-13:50 (15+5) | Development and Implementation of the Monocyte Activation Test: The NBI Experience | Jaclyn Scheepers, Special Scientist: Cell Biology National BioProducts Institute, South Africa |
| 13:50-14:10 (15+5) | Use of different MAT formats in testing human Albumin preparations. | Marijke Molenaar-de Backer, PhD, Sanquin Diagnostic Services, The Netherlands |
| 14.10-14:30 (15+5) | German NCL MAT experience with blood derived products | Ingo Spreitzer, Deputy Head of Section 1/3 Microbiological Safety, PEI, Germany |
| 1 hour and 20 mins | Vaccines Chair: Eliana Coccia, ISS | |
| 14:30-14:50 (15+5) | The use of MAT for Yellow Fever Vaccine quality control. | Octavio Presgrave, BraCVAM, Brazil |
| 14:50-15:10 (15+5) | Application of Monocyte Activation Test for the Assessment of Tick-Borne Encephalitis Virus Vaccine Pyrogenicity | Marilena P Etna, Researcher, ISS, Italy |
| 15.10-15:30 (15+5) | Implementing MAT for a Pyrogenic vaccine | Hilde Ohldieck Jarstadmarken, Senior Adviser, Norwegian Medical Products Agency |
| 15:30-15:50 (15+5) | Assessing reactogenicity of outer membrane vesicle (OMV) vaccines with MAT | Marijke Molenaar-de Backer, PhD, Sanquin Diagnostic Services, The Netherlands |
| 15:50-16:25 (35) | Roundtable: discussion on technical and regulatory challenges, experiences and lesson learnt Based on the registration survey’s results and questions Chairs: Laura Viviani, SciEthiQ and Paul Stickings, MHRA | |
| 16:25-16:30 (5) | Closing remarks and next steps | Laura Viviani, SciEthiQ on behalf of AFSA |
[1] HSI’s project: https://www.afsacollaboration.org/new-assays-implementation-and-acceptance/
[2] EDQM/EPAA event link: https://www.edqm.eu/en/-/joint-edqm-epaa-event-the-future-of-pyrogenicity-testing-phasing-out-the-rabbit-pyrogen-test
Event report: https://www.sciencedirect.com/science/article/pii/S1045105623000404?via%3Dihub
[3] NC3Rs report: https://nc3rs.org.uk/sites/default/files/2023-10/NC3Rs%20report%20to%20WHO%20ECBS%20-%20Review%20of%20animal%20testing%20requirements%20in%20WHO%20guidelines%20and%20recommendations%20for%20biologics.pdf