Mapi Pharma has signed a long term lease agreement at the Har-Hotzvim Hi-Tech Park in Jerusalem to establish a new sterile production plant for GA Depot injectable products.
The new leased area is comprised of 50,000 square feet for a commercial scale production facility.
The new facility includes a GMP approved API facility in Neot Hovav and a GMP approved QA laboratory in Ness Ziona. The company operates to supply the ongoing clinical trials (Phase II, III).
The facility includes the clean room infrastructure with a very high standard quality. The facility is located in zone a region, allowing tax benefits and grants, and providing employment source to tens of people.
The new facility is partially funded by Israeli Ministry of the Economy by a grant of US$2.5 million as a part of US$13 million for the equipment.
New facility is equipped with industrial production reactors, ranging up to 4,000l and also features small-scale production, supporting initial scale-up and sales. All the productions are expected to be exported.
GA Depot is a long-acting Glatiramer Acetate (Copaxone®) sterile injection that is currently being investigated for treating Relapsing Remitting Multiple Sclerosis (RRMS) and Primary Progressive Multiple Sclerosis (PPMS).