Zelluna Immunotherapy appoints MaSTherCell for process development and manufacturing of TCR adoptive cell therapy platform.
The partnership provides Zelluna access to MaSTherCell’s cell therapy manufacturing expertise and capabilities. The selection of the CDMO is an important milestone for Zelluna on its path to clinical trial readiness and commercialization of Zelluna’s TCR-T multiple targets program. The partnership also enables MaSTherCell to strengthen its presence into the solid tumors TCR manufacturing field.
MaSTherCell, the Global Brand
MaSTherCell will become the global brand of Orgenesis' CDMO network.
This reorganization aims to create a more efficient structure that can broaden, streamline and harmonize the CDMO service offerings on a global basis. The harmonization of the Quality System within each site enables an optimized and fast-track intercontinental technology transfer for worldwide clinical and commercial manufacturing.
The MaSTherCell sites are hence located in Belgium, South Korea, Israel and soon in the US.
MaSTherCell Receives €5 million Equity Investment from SFPI
GOSSELIES, Nov. 21, 2017 -- MaSTherCell, a full service contract development and manufacturing organization (CDMO), wholly-owned subsidiary of Orgenesis Inc. (OTCQB:ORGS), today announces it has entered an agreement with Société Fédérale de Participations et d'Investissement (“SFPI”), pursuant to which SFPI is making an equity investment in MaSTherCell, Orgenesis’ wholly-owned Belgian-based subsidiary, in the aggregate amount of €5 million (approximately $5.9 million) for 16.67% of MaSTherCell.
GMP Accreditation Renewal
Following the audit of our GMP activities by the FAMHP (Federal Agency for Medicines and Health Products), we are pleased to announce the successful completion of the audit with no critical deficiencies and no major deficiencies. Once again we have met the requirements and our GMP certificate is extended thanks to the hard work of the MaSTherCell’s team. We also received a favorable opinion to extend the authorization to the manufacturing of gene therapy products.
We think that quality must be done right through our best-in-class quality services but also daily in our quality-minded work and transparent communication.
The Process Diagnostic : How to optimize the technology transfer and the development
A critical aspect of cell therapy industrialization is process development. It is all about how to industrialize the cell therapy product within short time frames. MaSTherCell has developed a process diagnostic tool to help put together the development plan. Mathieu Anceau, Technology Transfer Supervisor at MaSTherCell, tell us more about it. He explains how creating a strong process diagnostic lays the foundations for a successful technology transfer and development towards a process fit for industrialization.
Click here to download the paper.
Discover our brand new Virtual Reality Facility
We will be presenting at the Cell Therapy Manufacturing and Gene Therapy Congress our Virtual Reality Facility. Have an insight into our facility in Belgium and discover how we work.
Give it a try at the booth#31 and contact us.