The Hadassah Stem Cell Research Center was established in 2003 in order to develop technologies for the use of stem cells in regenerative medicine and cell-based therapies to treat human disease. After identifying the need for clinical-grade hESC lines that were not available at the time, we were pioneers in deriving three GMP-grade, xeno-free (XF) hESC lines on human fibroblast feeders, which are suitable for further manufacturing purposes (described in (Tannenbaum et al., 2012)) for use in preclinical studies and clinical trials. In 2018, we transformed our three existing clinical-grade hESC lines into a new culture system that is GMP, xeno-free, and fibroblast feeder independent. Using this new culture system, we further derived four new clinical-grade hESC lines, also fibroblast feeder independent, which were previously unreported.
The Center’s goal is to supply clinical and research-grade hESCs to academic and commercial entities for the promotion of hESC-based clinical therapies for drug discovery and basic research.
The Hadassah Stem Cell Research Center is directed by Professor Benjamin Reubinoff, Chairman of the Department of Obstetrics and Gynecology at Hadassah. Professor Reubinoff has been among the world pioneers in the field of hESC derivation from human embryos and in their development. The Hadassah Stem Cell Research Center team includes a staff of senior scientists, technicians, and students.
The Manufacturing and QC personnel who derived and characterized the cell lines are highly qualified in the field of stem cell banking, characterization and distribution. Our Manufacturing team is skillful in stem cell production and cryopreservation under research and cGMP conditions. It has extensive experience in cGMP production of cell lines for clinical applications. The Quality Control technicians are proficient in testing cell lines according to the highest quality standards. The Hadassah Stem Cell Center’s Quality Manager has over 30 years’ experience in the pharmaceutical, medical and biotechnology fields.
Our mission is to serve the research, academic and commercial communities by providing high quality cell lines and personal service with professionalism and open, direct and rapid communication.
Key Members of the Hadassah Stem Cell Line Derivation Team include:
Prof. Benjamin Reubinoff
Prof. Reubinoff received his M.D. degree from the Hebrew University – Hadassah Medical School, Jerusalem, Israel, and completed his residency in Obstetrics and Gynecology at the Hadassah Medical Center. He holds a PhD degree in developmental biology from Monash University, Melbourne, Australia. Prof. Reubinoff serves as Chairman of the Department of Obstetrics and Gynecology at Hadassah University Medical Center, Jerusalem and is the director of the Sidney and Judy Swartz Stem Cell Research Center of the Goldyne Savad Institute of Gene Therapy at Hadassah. He founded and serves as the Chief Scientific Officer (CSO) of Cell Cure Neurosciences Ltd.
The major focus of Prof. Reubinoff’s research has been human embryonic stem cells (hESCs). Professor Reubinoff has been among the world pioneers in deriving ES cell lines from human embryos.
Prof. Reubinoff’s main interests involve the development of the technologies that allow the exploitation of hESCs for regenerative medicine. Towards this goal, he established hESC lines that are suitable for clinical applications, and further derived progeny from these hESC lines for the treatment of neural and retinal degenerative disorders.
Ms. Tannenbaum received her MSQA from California State University, Dominguez Hills and has a BS in Microbiology from UCLA. She has been the Quality Manager of the Hadassah Stem Cell Research Center since 2002. Shelly was a driving force behind the derivation and characterization of the GMP-grade, xeno-free hESC lines which are suitable for clinical transplantation use. She has also served as the QA Director of Cell Cure Neurosciences Ltd., and has functioned in other quality and validation positions in organizations such as 3M Pharmaceuticals, Amgen Inc., and Siemens-Pacesetter Systems. Ms. Tannenbaum is highly experienced and successfully established the Quality Management System platform of the Hadassah Stem Cell program that enabled the development of hESCs for clinical transplantation applications. In this role, Ms. Tannenbaum implemented quality systems in accordance with FDA and European requirements.
Orna Singer, MSc
GMP Manufacturing Specialist, GMP Manufacturing Team Lead
Mrs. Singer received her MSc. from Hebrew University, in Biochemistry. Her extensive experience entails the successful derivation of GMP-grade, xeno-free hESC lines which are suitable for clinical transplantation. Mrs. Singer has a comprehensive background working under GMP conditions performing aseptic processing in ISO Class 7 cleanrooms as well as in ISO Class 5 biological safety cabinets. Orna leads the GMP Manufacturing, Process Validation and Material Qualification teams.
Additional Team Members
QC Method Development Specialist, QC Characterization Team Lead, GMP Manufacturing Technicians
Our team members have extensive experience in GMP-grade hESC bank method development and characterization. Their specialties include cellular and molecular biology techniques, transfection, and gene-editing procedures including CRISPR-Cas9 application, hESC line derivation and characterization, including studies in vivo, novel in vitro methodology, and innovative and improved cGMP manufacturing and characterization methods.