About GMP Biomanufacturing Services
Cedars-Sinai Biomanufacturing Center
Cedars-Sinai Biomanufacturing Center (CBC) is a new 22,000 square feet, state-of-the-art biomanufacturing facility located in West Hollywood, California. The CBC comprises a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies.
These new therapies will be used for human IND-enabling clinical trials. With combined expertise in a cGMP-compliant approach to manufacture cells at scale, the CBC will overcome many challenges by building innovative technologies, connecting protocols, up-scaling of processes and achieving Food and Drug Administration standards for all steps involved to bring innovative cell therapy solutions to researchers and translation scientists. With our world-class expertise in stem cell (iPSC) biology, bioprocessing, translational medicine and manufacturing, the CBC is providing a much-needed biomanufacturing center in Southern California.
GMP manufacturing capabilities include, but are not limited to:
- Technology transfer
- Mammalian cell banking
- Master cell bank and working cell bank creation and validation
- Process development and optimization
- Pilot lots for R&D and validation
- IND support
- cGMP lot production
- iPSCs and derivatives
- CAR-T and NK-cell therapies
- Adult stem cells and progenitors (neural, cardiac, retinal and others)
- Stem cells for orthopaedic/skeletal indications
- Associated quality control services
The CBC houses about 6,600 square feet of cleanroom space including:
- Seven cGMP cleanroom (ISO 7) cell production suites
- One media preparation suite
- One vial fill room
- Staging room
- Freezer and liquid nitrogen storage room
- Receiving and storage
- Specialized bioreactors and CliniMACS Prodigy instruments
Our facility also includes seven process development suites for producing the next generation of cell and gene therapies.
To support scalable expansion of cells in defined cGMP-compatible media, we have the latest clinical-grade cell sorters, scalable bioreactor systems and automated cell harvesting.
There is also nearly 5,000 square feet of dedicated adjacent cell culture labs for incorporating practical stem cell training, practical modules and education of the next generation of scientists specializing in biomanufacturing.
Equipment in the CBC supports academic, clinical and commercial researchers and investigators to provide for the development and scalable manufacture of clinical-grade cell therapy products in compliance with current cGMP regulations suitable for investigational use in humans; development of iPSC-based and gene-edited cell products for research and drug discovery programs; and training of multiple individuals per week in iPSC and cGMP technologies.
Who we serve:
- Cedars-Sinai faculty
- External academic organizations
- Commercial and industry clients
The CBC is committed to manufacturing the highest quality innovative cell and gene therapy products that meet or exceed our customers’ requirements and expectations. We apply good scientific practices to provide diverse quality products and services. As dedicated partners in biomanufacturing, we pledge to provide the highest levels of quality and safety of the manufactured products through robust and effective quality systems, process controls, rigorous performance criteria and testing.
We will strive to maintain compliance with cGMP regulations, with a focus on continuous improvement, monitoring and measurement of our core process metrics to ensure effectiveness.
About the iPSC Core
iPSC Research Services
Click here to contact the iPSC Core and Biomanufacturing Center.