Advanced Biotherapy Center (ABC), Sheba Tel HaShomer City of Health

The Advanced Biotherapy Center (ABC) at Sheba Medical Center is an academic R&D and cGMP manufacturing laboratory for cell, gene, and tissue therapies. The center provides both development and manufacturing services and paid cleanroom access for outside groups. The center also supports investigator-initiated trials with academic partners at Sheba and beyond. Partnering with ABC will give you access to expertise and infrastructure at a reasonable cost that would otherwise cost millions of dollars to build or to purchase from an international commercial CDMO. The clean rooms meet requirements for manufacturing of Advanced Therapy Medicinal Products (ATMP) for phase 1/2 trials. (In the United States, ATMP are also known as HCT/P). The center has 500m2 top-of the-line classified area, including four Grade B clean rooms and a dedicated viral vector manufacturing suite. In addition, there is 300m2 of process development and QC laboratory space. The center manufactures gamma retroviral vectors for both preclinical research and at clinical grade for use in cell and gene therapy clinical trials. It is the only center in Israel with the capability to produce GMP grade vector. ABC provides full development and manufacturing support for phase 1/2 clinical trials, including comprehensive QA and QC. We are able to tech transfer to another CDMO when/if necessary as a project scales up and requires a dedicated GMP facility. Our mission is to establish The Advanced Biotherapy Center (ABC) at Sheba Medical Center as the lead for development & manufacturing of cell, gene and tissue therapy (one stop shop), improving patient's outcome and driving medical progress. Facility Director: Jonathan Esensten MD, PhD Jonathan.Esensten@sheba.health.gov.il +972-53-5270661