Cedars-Sinai has launched a centre to manufacture the next generation of stem cell and gene therapies that will enable biomedical researchers, government medical programs, commercial entities and others to develop new biologic drugs and propel novel disease discoveries.
Biologic drugs are produced from living organisms or contain components of living organisms, such as cells, proteins or genes.
“The Cedars-Sinai Biomanufacturing Center leverages our world-class stem-cell expertise, which already serves scores of clients, to provide a much-needed biomanufacturing facility in Southern California,” said Clive Svendsen, Executive director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute. “It is revolutionary by virtue of elevating regenerative medicine and its therapeutic possibilities to an entirely new level-repairing the human body.”
Among the facility’s initial clients is the Department of Defense, which has asked Cedars-Sinai scientists to manufacture banks of stem cells from multiple healthy volunteers for later use in repairing vascular injuries sustained by military personnel in combat.
The core technology of the Cedars-Sinai Biomanufacturing Center involves production of specialised cells known as induced pluripotent stem cells, or iPSCs. Scientists make iPSCs by genetically converting adult blood cells into cells that can self-renew indefinitely and differentiate into nearly any type of tissue. Each resulting cell carries the exact DNA of the person who donated the blood sample.
“IPSCs are powerful tools for understanding human disease and developing therapies,” said Dhruv Sareen, PhD, executive director of the Biomanufacturing Center and director of the induced pluripotent stem cell facility at the Regenerative Medicine Institute. “These cells enable us to truly practice precision medicine by developing drug treatments tailored to the individual patient or groups of patients with similar genetic profiles.”
The Biomanufacturing Center is designed to address a critical bottleneck in bringing cell- and gene-based therapies to the clinic. It will help relieve a nationwide shortage of facilities that can scale up production of cells for drug products that consistently meet current good manufacturing practice (cGMP) standards for strength, quality, and purity. These standards, set by the U.S. Food and Drug Administration, must be met when producing pharmaceuticals for use in humans.
To comply with the federal standards, the new Cedars-Sinai centre features nine cleanrooms that maintain rigorously aseptic conditions for handling of all biomaterials. These rooms are supported by staging areas, gowning rooms, quality control laboratories and storage rooms with ample freezers and liquid nitrogen tanks.
Other sections of the Biomanufacturing Center are devoted to research and production of iPSC cells, technology and development, training and collaboration laboratories, offices, and facilities maintenance equipment. Overall, the centre occupies more than 28,000 square feet.
“Our expansive facilities provide complete, end-to-end support of biomedical research and development of cell therapies that are ‘living medicines,'” said Sareen, assistant professor of Biomedical Sciences. “We enable our clients to explore and create new types of cells, use them to make discoveries about diseases and transform the resulting biomaterials into cGMP-compliant therapies for testing in clinical trials.”
The recent grand opening of the Biomanufacturing Center, hosted on a virtual platform by Cedars-Sinai leadership, was attended by representatives of local and federal governments, biotechnology companies, funding organisations and other stakeholders. It was followed by another Cedars-Sinai virtual event, a Symposium on Translational Medicine and Biomanufacturing, that drew world-renowned keynote speakers from academia and industry and hundreds of attendees to explore the latest developments in these fields.
“Our new Biomanufacturing Center reaffirms Cedars-Sinai’s commitment to deliver the finest clinical care for our patients-and patients everywhere-by expanding the frontiers of medical science,” said Svendsen, professor of Biomedical Sciences and Medicine.
Image credit: CDC