Cell Therapy

During the last two decades cell therapy and cell-based regenerative medicine industry is considered to be the most promising industry for un-met medical needs. Gsap is working today with the majority of the companies in this field in Israel.

Trends in this industry are shifting according to the new promising discoveries and understanding of disease models, cells mode-of-action, safety aspects, manufacturing constraints, and more. The constantly evolving regulatory environment is posing new challenges for this industry as well.

Israel is considered to be one of the leading countries in this industry, with about 20 active companies at various stages of pre-clinical and clinical research. As new ideas for therapeutic products are constantly emerging, the new entrepreneurs realize very early in the development process that quality assurance and regulatory attributes should be embedded in the product development from a very early stage.

Gsap is working today with the majority of the companies in this field in Israel. Our clients benefit from experienced consultants each having significant industrial, scientific, quality assurance and/or regulatory expertise. Our services include early product development, GMP process translation, quality system implementation and pre-clinical studies design. We also provide regulatory affairs services in USA, EU and Israel.

We have proven experience with a large portfolio of therapeutic products: cell and gene therapy; autologous and allogeneic cell therapy; adult and pluripotent stem cells, tissue regeneration; CAR-T cells. Among our clients in this field are: Pluristem Therapeutics, CellCure NeuroScience, Kadimastem, BioGenCell, Bonus BioGoup, Haddassah, Sheba and Sourasky Medical Centers, Brainstorm Therapeutics, Sheltagen, Cytora, Accellta and others.