Servier appoints MaSTherCell for the development of its CAR-T cell therapy manufacturing platform
Suresnes, France and Brussels, Belgium - 18 January 2017 – Servier, the independent international pharmaceutical company, and MaSTherCell SA, the full-service contract development and manufacturing organization (CDMO) specializing in the delivery of optimized process industrialization capacities to cell therapy organizations, today announced the signing of a master service agreement for the development of a manufacturing platform for allogeneic cell therapies.
Under the master service agreement, MaSTherCell is developing a CAR-T cell therapy manufacturing platform, which will enable industrial and commercial manufacturing of Servier cell therapy products. This is a critical step in development of these products for later stage clinical trials.
Cell therapies have shown promising results in treating cancers. However so far, successful development has been mainly limited to autologous therapies. This approach, where the patient’s cells are collected then used to create a drug for that specific patient, is limited by the lack of possibility of industrialized manufacturing, thus restricting its access to few patients. Allogeneic therapies, or off-the-shelf treatments, potentially offering the technology to a higher number of patients, are developing very rapidly. However the challenges of their manufacturing scale-up still lie ahead.
One of the most advanced cell therapies is based on CAR-T technology, where the T-cells are armed with a Chimeric Antigen Receptor. Servier is developing UCART-19 (see below About UCART-19 for more information), with two clinical trials currently ongoing in Europe, in relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL), in pediatric and adults patients.
Servier selected MaSTherCell because of its leading global cell therapy CDMO position as well as its essential broad expertise in immunotherapy products. MaSTherCell has a track record of designing and delivering cost-effective cell therapy manufacturing platforms.
MaSTherCell anticipates that it will complete the development of the initial CAR-T platform in 2018. This will then be an efficient complement to the bioproduction facilities that Servier is developing at its site at Gidy (France), which will mainly focus on the production of antibodies.
“This partnership will result in developing solutions for one of the biggest challenges to the ongoing development of the cell therapy sector. MaSTherCell has quickly built the most extensive CDMO experience in manufacturing and process industrialization development in the cell therapy industry,” said Denis Bedoret, CBO at MaSTherCell. “This enables MaSTherCell to leverage that experience to deliver solutions to contribute to the Servier cell therapy pipeline. We will thus be able to directly contribute to delivery of life-saving cell therapy treatment to patients”.
“The scale up of manufacturing for late scale clinical trials still remains one of the biggest industry-wide challenges in the cell therapy sector, and especially in a CAR-T field still in its infancy,” said Marielle Anger-Leroy, Director of Biotechnology Industrial Development at Servier. “Being pioneers with these innovative therapies means that we have to find the best partners to maximize the chances of delivering these therapies to patients with few alternative options.”
Cell therapy, a promising sector in Wallonia
The Walloon cell therapy platform represents a strong ecosystem with cell therapy companies, academics, research laboratories, institutions and services companies which transform challenges into opportunities. Sylvie Ponchaut at BioWin, the Health Cluster in Wallonia, presents those opportunities that contribute to develop Wallonia and Belgium.
This article is taken from European Biopharmaceutical Review October 2016, , pages 32-34. © Samedan Ltd
We are pleased to announce that we have been selected by Adaptimmune as a supplier of cell therapy products for use in Adaptimmune’s clinical trials. This deal confirms once again MaSTherCell as a key partner for immuno-based cell therapy.
How to integrate flexibility to carry out multiple production projects and move towards commercialization
Eric Mathieu, COO of MaSTherCell, shares the story behind this new extension.
Update on implementations of large scale capabilities
Besides the new extension, we made some improvements to our current facility to cope with the increasing manufacturing needs:
- Larger grade B production rooms for more flexibility
- New grade C clean room
- Expansion of Quality Control laboratories
- Expansion of logistics to support the activities
Together for better. One year ago, Stephanie Verbrugghe, QP at MaSTherCell took the initiative of bringing together Belgian companies active in the production of ATMPs. Following the EMA consultation on the development of Good Manufacturing Practice for Advanced Therapy Medicinal Products, she invited her counterparts to discuss and comment the proposed requirements . Then she organized a discussion with GMP inspectorate representatives of the FAGG/AFMPS. Altogether, quality and regulatory experts from companies like Bone Therapeutics, Celyad, MaSTherCell, Novadip, Promethera Biosciences, TiGenix, TxCell and eTheR-NA helped clarify grey zones and identify where GMP requirements are impractical for ATMP production. The group's consolidated comments have been submitted by Novadip to the EMA through Bio.be.
The consulted document was the proposed guidelines linked to the Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on ATMPs.