Orgenesis Inc., a leader in the emerging fields of cellular therapy and re-generative medicine today announced that its Belgian subsidiary, Orgenesis SPRL, has signed a strategic agreement with MaSTherCell SA of Gosselies, Belgium. Orgenesis believes that the agreement will enable Orgenesis to advance its manufacturing (GMP) process from lab scale to clinical scale as it prepares for Phase I and Phase II clinical trials.
"The team at MaSTherCell has the right mix of capabilities, experience, technology and manufacturing processes in place to make it a natural fit for Orgenesis and will give us scalability in our efforts to have a significant impact on Type 1 diabetes," said Jacob BenArie, CEO of Orgenesis Ltd. and Orgenesis SPRL. "We wanted a partner with a centrally located facility in Europe. MaSTherCell is located in the Walloon region of Belgium with access to a large biotech talent pool which they may tap into as we scale up our operations and activities."
Orgenesis is a pioneer in the field of 'cellular trans-differentiation,' a process that the company is developing to transform a type 1 diabetic patient's own liver cells into new insulin-producing cells. Cellular trans-differentiation involves a complex biologic process, and requires sophisticated manufacturing technology and capabilities. MaSTherCell has the experience, system design and cutting-edge technology in place to deliver the control properties and conditions needed for the live cell culture and expansion process critical to commercial scale manufacture of Orgenesis cellular trans-differentiation products.
Upon signing the agreement, Hugues Bultot, CEO of MaSTherCell SA, said, "Orgenesis has an innovative approach and we are proud to be part of this venture. It is gratifying to see our cell therapy development and manufacturing service capabilities being used to support Orgenesis as they move ahead with their efforts to help patients suffering from Type 1 diabetes. We look forward to fulfilling the new role entrusted to us, and to working with Orgenesis moving forward."
Services will commence upon approval of The Directorate General operational for Economy, Employment and Research (DGO6) of Belgium, which will be providing grants to fund the research and manufacturing activities.