US-based biotechnology and medical equipment company Thermo Fisher Scientific has opened a new current good manufacturing practice (cGMP) manufacturing facility to expedite the development of advanced cell therapies for critical conditions, including cancer, rare diseases, and other illnesses, in March this year.
The facility is located adjacent to the University of California, San Francisco鈥檚 (UCSF) Medical Centre鈥檚 Mission Bay campus in the US.
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Thermo Fisher formed a strategic partnership with the UCSF to open the cell therapy cGMP manufacturing and collaboration centre in May 2021.
The UCSF will initially focus on developing treatments for glioblastoma, multiple myeloma, and other cancers using advanced approaches to CAR-T and CRISPR technologies. Plans for developing therapies for other difficult-to-treat conditions are in the works.
The facility offers process and analytical development capabilities, as well as clinical and commercial manufacturing services for advanced therapies to the UCSF and other customers.聽Customers will also benefit from Thermo Fisher鈥檚 end-to-end drug development capabilities including discovery, clinical research, and commercialisation.
The facility forms part of Thermo Fisher鈥檚 global pharma services network, which includes more than 15 sites supporting cell and gene therapies.
Details of Thermo Fisher’s new cGMP production facility
Thermo Fisher built a state-of-the-art 44,000ft虏 cell therapy collaboration centre on a leased space on UCSF’s Mission Bay campus, which includes biomedical research facilities and hospitals. The facility offers end-to-end solutions to accelerate cell therapy development and manufacturing.
It will also serve as a hub providing access to Thermo Fisher’s broad portfolio of Cell Therapy Systems (CTS) reagents, consumables, fit-for-purpose instrumentation, and compliant software to customers and UCSF researchers.
The CTS product portfolio is designed to streamline cell therapy production and enable a smooth transition from research to clinical manufacturing.
Thermo Fisher’s CDMO services
Patheon Pharma services, a part of Thermo Fisher Scientific, offers contract drug manufacturing organisation (CDMO) services that include end-to-end advanced therapy development and manufacturing services, including cell and gene therapies.
As a CDMO partner, Patheon has the expertise, capacity, and global supply network to transform advanced therapeutics, from discovery to commercialisation.
CDMO offers translational services, manufacturing and development services that include cell therapy, plasmid DNA, viral vector, mRNA, and clinical supply chain solutions.
Patheon鈥檚 translational services include custom molecular biology, viral vector packaging, and cell therapy services to advance cell and gene therapies from discovery to the clinic.
It provides cGMP manufacturing for autologous and allogeneic workflows across various immune and stem cell types, process development and optimisation, analytical assay development, and QC testing as a comprehensive cell therapy manufacturer.
Patheon viral vector services include process and analytical development to the clinical and commercial supply of viral vectors, cell and gene therapies, and vaccines.
The plasmid DNA cGMP manufacturing and QC analytical capabilities enable quality material at all stages of development and commercialisation and ensure getting the service offerings to the market faster.
With several manufacturing platforms, Patheon can develop and produce cGMP viral vectors, including adeno-associated virus, adenovirus, lentivirus, herpes simplex virus, and retrovirus.
The mRNA capabilities of Patheon鈥檚 global network include linearisation, process and analytical development, cGMP manufacture for synthesis and liquid nanoparticles, sterile fill and finish, and logistics and supply chain networks.
It also offers clinical supply chain solutions such as maintaining cell and gene therapies’ speed, temperature, and integrity.
Marketing commentary on Thermo Fisher
Thermo Fisher has more than 20 years of experience in cGMP advanced therapeutic manufacturing.
With more than 60 locations globally, it offers integrated, end-to-end capabilities across all developmental phases, including active pharmaceutical ingredients biologics, viral vectors, cGMP plasmids, formulation, clinical trial solutions, logistics services, commercial manufacturing, and packaging.
It has manufactured more than 500 viral vector cGMP clinical and commercial lots and has produced more than 130 viral vector products globally. It has a flexible network of 45 drug substance suites worldwide.
Its digital platforms, such as the mysupply platform and Pharma 4.0 enablement, provide real-time data and streamlined workflow.
Thermo Fisher Scientific鈥檚 portfolio includes Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, Ion Torrent, Gibco, and PPD.
