Monocyte Activation Test – MAT - A Joint Workshop of the Paul-Ehrlich-Institut (PEI) and ECA

7 September 2016

Frankfurt/Langen, Germany

Seminar Nr. 15500

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Speakers

Speakers from Authorities:

Dr Klaus Cussler, Paul-Ehrlich-Institut, Germany

Dr Don Singer, USP, USA

Dr Ingo Spreitzer, PEI, Germany

Dr Karin Nordgren, NIBSC

Speakers from Industry and Science:

Kristin Kowalick, Labor L+S AG, Germany

Dr Anja Fritsch, Confarma, France

Dr Katarzyna Marciniak-Darmochwal, Charles River Laboratories, Ireland

Dipl Ing Maike Piehler, Microcoat, Germany

Dr Astrid Visser, Sanquin, The Netherlands

Dr Walter Zwisler, Zwisler Laboratory, Germany

Objectives

The first workshop on MAT was held at the Paul-Ehrlich-Institute on 22 November 1999, so to say in the last Millennium. This was my first visit to the PEI (still working on my PhD thesis in Constance), the icy weather caused many accidents and obstacles on the road.

Since then we have seen a lot of obstacles hindering the widespread implementation of the MAT, although during the last 17 years an enormous effort and progress was achieved by several esteemed partners within the community.

The European validations (together with ECCVAM) were finalized and accepted successfully. With continuous support by the German Pharmacopeia, the EDQM MAT Expert group was re-established and finally the MAT Monograph 2.6.30. was implemented into the European Pharmacopeia in 2010. Meanwhile, the EDQM performed an MAT survey to improve the MAT monograph. The BET Guideline 5.1.10. and the Rabbit Pyrogen Test (RPT) monograph 2.6.8. have been revised to clarify the priorisation of the MAT compared to the RPT (especially in regard to the EU Directive 2010/63). Furthermore, the microbial safety unit at the PEI discontinued the RPT at the end of 2014, thus highlighting the significance of the MAT.

In a series of workshops and conferences MAT experts shared their thoughts with those who were interested and/or affected by these developments.

Finally, after more than 20 years, we have reached a point where we have to do what we worked for all the time: Replacing a good and predictive animal test with an even better alternative method.

The purpose of this workshop is to provide the participants with guidance and support for the upcoming changes, a vision which both the PEI and the ECA share. Experts from Authority, Industry and Contract Laboratories will provide insight into their experiences with the implementation of MAT.

With best regards,
Dr Ingo Spreitzer, PEI

Background

During recent years manifold advances have taken place to replace both Rabbit Pyrogen Test (RPT) and Limulus Amebocyte Lysate Test (LAL).

Some of the reasons are:
Animal experiments have to be reduced. Especially with the current EU Regulations. Also the LAL test is not a true in vitro test.
Get an alternative Test, where the classic LAL shows some gaps, e.g. Contamination of biologicals by non-endotoxin pyrogens not detectable in LAL test is not unlikely.
LAL reagent has to be harvested from Horseshoe Crabs. An environmental or an ecological disaster could extinguish the Limulus population.

True In-vitro Pyrogen Tests (IVPT) have been developed in several European countries (United Kingdom, The Netherlands, Switzerland, Germany) in national and international research projects. The tests imitate the central step of human fever reaction, i.e. the activation of human monocytes by endotoxin as well as non-endotoxin pyrogens. One result of all these activities is the Monocyte Activation Test (MAT).

This unique event is jointly organised by the Paul Ehrlich-Institut – Federal Institute for Vaccines and Biomedicines and the ECA Academy to bring together European industry and regulatory representatives in order to discuss the practical experiences in using MAT, the advantages, the pitfalls, the available systems as well as the regulatory experiences.

Target Group

This workshop is addressed to all persons of pharmaceutical manufacturers, biopharmaceutical companies, medical device manufacturers, contract laboratories, tissue establishments, and authorities who are involved in Endotoxin- and Pyrogen Testing in development, IPC or release.

Programme

Current Developments on MAT

Drivers for MAT-related pharmacopeial changes: Users and EU-Directive
The interaction of 5.1.10., 2.6.8. and 2.6.30.
MAT availability
PEI position on MAT

USP Requirements and Regulatory Thinking

Current Regulatory Background
Expected Developments

Implementation of Alternatives to Animal Safety

History – the Issue of solving Salvarsan “Sodium Chloride/Water Fever”
Development of JEG 3R (replacement, reduction, refinement)

MAT – pitfalls and lessons learned

MAT - one test various test procedures
Pros & cons from the perspective of a contract laboratory
Critical aspects of the test
Blood source
Realization of the Ph.Eur. requirements: 4 Replicates, LOD
Summary: Points to consider for the routine use of MAT

MAT using cryopreserved pooled PBMCs

MAT as pyrogen test
Characteristics and Performance of MAT assay of Sanquin
Examples of validation and drug release testing of plasma derived products
Critical aspects and tips for performing MAT

MAT use for Medical Devices

Medical Devices vs pharmaceutical samples
Pooled human cryoblood experience

MAT Testing with Monomac6 Cell Line

Advantages of performing the MAT in a routine Laboratory using a cell line
Assay characteristics
Experiences with validations and routine testing

Experiences with MAT

Evaluation of a one-step MAT assay
Feasibility data using various pyrogen
Validation concept for MAT as a generic pyrogen test

MAT Batch release of modern vaccines

OMV-based vaccines and pyrogen testing
MAT-approach for batch release

Overcoming the Challenges in Establishing Routine MAT Assay

The MAT assay and testing of different sample/product types
A look at the types of interference that may be seen with the assay
Controlling the robustness of the MAT assay

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