UPDATED: UCART19
Servier universal CAR-T therapy outsourced to Belgian CDMO
Cellectis SA developed a T-cell platform with engineered chimeric-antigen receptors (CAR-T) based on the CD19 target, which Servier went on to acquire the exclusive rights to in November 2015.
The resulting candidate, UCART19, is a “universal” off-the-shelf cell therapy to treat blood cancers, currently being trialled in the EU for relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) in both children and adults.
Both Servier and Cellectis are therefore working to develop the CAR-T platform for UCART19.
Servier has will work with MaSTherCell to help prepare for full-scale manufacturing of the CAR-T platform, with initial preparations projected to be complete by 2018.
MaSTherCell will work alongside the Servier facilities under development in Gidy, France, which focus on bioproduction of antibodies.
The CDMO has a cGMP-certified manufacturing facility with around 80 staff based in the Walloon healthcare cluster (BioWin) in Gosselies, Belgium.
Denis Bedoret, CBO of MaSTherCell told Outsourcing-Pharma "Each of the partners involved have chosen to develop their own platform and work with different CDMO partners."
"At the moment all parties are still involved in making sure the IP licensed is received properly and the knowledge is transferred to manufacture UCART19," he added.
BioWin bioproduction
MaSTherCell’s 600 sq m facility in the BioWin park has 4 units and a tech transfer lab, equipped with bioincubators with up to 700L capacity and a licence from the Belgium Regulatory Agency for manufacturing cell and gene therapy (ATMP) products.
These include the Wave (from GE Healthcare), a Quantum hollow-fibre cell expansion system (Terumo) and an iCELLisfixed-bed bioreactor (Pall Lifesciences). "We don't actually own any in-house bioreactors or have a policy to work with a single one, typically working with clients to acquire a specific piece of equipment," Bedoret told us.
"This is because as a CDMO we normally work with earlier stage projects where we might ask for a partnership later on in the development. But this isn't the case with Servier."
The facility also has a Quality control suite, employing use of a FACS Verse Flow Cytometer (BD), a molecular device microplate reader 190-850nm, a 7500FAST qPCR (Applied Biosystems) to test purity of the cell-based products.
“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,” explained Marielle Anger-Leroy, Director of Biotechnology Industrial Development at Servier.
To combat the challenge of manufacturing cell therapies, MaSTherCell added “We use dry plant and disposable single-use systems to avoid cross contamination, shorten set-up times and avoid the need for cleaning validation.”
Cell Therapy clients
MaSTHerCell SA was bought by Orgenesis Inc. back in 2015. Other clients of the CDMO include the biotechs Israel-based Gamida Cell, France-based TxCell and UK-based Adaptimmune.
TxCell outsourced manufacturing of its cell therapy Ovasave to MaSTHerCell after a hitch with the firm’s GMP manufacturing plant with the French medicines agency (ANSM) in 2015, however the partnership is currently on hold due to a complication with Ovasave's development.
