Virtual Workshop: Status of global implementation of MAT for biologicals. Product Specific Approaches and Regulatory Alignment

Microsoft Teams / 12 PM – 4:45 PM CEST
25th September 2024

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
Presentation Slides
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
Presentation Slides
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
Presentation Slides
Presentation Slides
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.
Presentation Slides
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
Presentation Slides 
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
Presentation Slides
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.
Presentation Slides
Marijke Molenaar-de Backer, PhD,
Sanquin Diagnostic Services, The Netherlands 
14.10-14:30 (15+5) German NCL MAT experience with blood derived products
Presentation Slides
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.
Presentation Slides
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
Presentation Slides
Marilena P Etna,
Researcher, ISS, Italy
15.10-15:30 (15+5) Implementing MAT for a Pyrogenic vaccine
Presentation Slides
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
Presentation Slides
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, Paul Stickings, MHRA and Dr Tong Wu, HealthCanada
16:25-16:30 (5) Closing remarks and next steps  Laura Viviani, SciEthiQ on behalf of AFSA 
Copyright Disclaimer: This video contains copyrighted material used under the fair use doctrine for educational and commentary purposes; all rights to the original content belong to their respective owners.

[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