Servier appoints MaSTherCell to develop its cell therapy manufacturing platform

Independent international pharmaceutical company Servier and MaSTherCell SA, the full-service contract development and manufacturing organization (CDMO) have signed a master service agreement for the development of a manufacturing platform for allogeneic cell therapies.

MaSTherCell SAmhat specialises in the delivery of optimised process industrialisation capacities to cell therapy organisations.

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, lacks the possibility of industrialised manufacturing, 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 T-cells are armed with a Chimeric Antigen Receptor. Servier is developing UCART-19 in relapsed or refractory B cell acute lymphoblastic leukemia in paediatric and adults patients.

MaSTherCell anticipates that it will complete the development of the initial CAR-T platform in 2018.

IThis 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.

IDenis Bedoret, CBO at MaSTherCell said: “MaSTherCell has quickly built the most extensive CDMO experience in manufacturing and process industrialisation development in the cell therapy industry.

“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.”

IMarielle Anger-Leroy, Director of Biotechnology Industrial Development at Servier, said: “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.

“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.”