Kangstem Biotech selects MaSTherCell for GMP manufacturing of FURESTEM-AD© in Europe
Seoul, Korea and Gosselies, Belgium, October 1, 2018 – Kangstem Biotech, a biotechnology company specializing in developing cell therapies using mesenchymal stem cells derived from human umbilical cord blood, today announces the selection of MaSTherCell as its contract manufacturing partner for its European clinical trial of FURESTEM-AD.
MaSTherCell announces planned investment for MaSTherCell Global of up to $25 Million
MaSTherCell announces planned investment for MaSTherCell Global of up to $25 Million to develop its global services through a strategic partnership between Orgenesis and Great Point Partners
MaSTherCell Global will beneficiate from a USD 25 million funding from a partnership between Orgenesis Inc. and Great Point Partners (GPP), a leading health care investment firm based in Greenwich, Connecticut, in order to finance, strengthen and expand MaSTherCell Global’s activities.
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.