Accelerate development of plasmid-based medicines and vaccines
Responding to critical market capacity constraints, Thermo Fisher announces the official opening of new 67,000 sqft cGMP plasmid DNA manufacturing facility in Carlsbad, CA. This site expands clinical and commercial capabilities for cGMP plasmid DNA used as a critical raw material to develop and manufacture cell and gene-based therapies in addition to capabilities to produce large-scale plasmid DNA as a primary drug substance for DNA therapies.
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Thermo Fisher showcases investments and innovations at DCAT Week 2021
Strategic investments expand global capabilities to support advanced therapies, large molecule development and manufacturing and clinical supply chain services. These investments, leveraging integrated service offerings and our expansive global network, helps accelerate innovative medicines, vaccines and therapies.
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Thermo Fisher Introduces New Quick to Clinic™ Solution at BIO Digital 2021
New and emerging biopharma companies working on early development can now leverage a better lab-to-clinic drug development solution designed to accelerate the journey from DNA to drug product. Thermo Fisher’s enhanced Quick to Clinic solution may help biopharma companies reach Phase I/First-In-Human trials and file for Investigational New Drug (IND) review in as little as 13 months from transfection.
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Enabling accelerated cell therapy development in partnership with UCSF
Thermo Fisher Scientific and the University of California, San Francisco (UCSF) have formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies. Thermo Fisher will build and operate a state-of-the-art cell therapy development, manufacturing and collaboration center on the UCSF campus, which will offer clinical and commercial cGMP cell therapy manufacturing services to UCSF and other partners.
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Thermo Fisher maintains leadership for outsourced NDA-approved products
Over the last decade, Patheon pharma services has supported the delivery of more NDA-approved drugs than the next three leading CMOs combined, according to the 2021 edition of New Drug Approvals and Their Contract Manufacture report by GlobalData. What’s more, we’ve delivered across all phases of drug development and across the world through our full-service global network.
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FDA approval for Abecma® Recognized with Donation to Leukemia & Lymphoma Society
Thermo Fisher Scientific has made a donation to the Leukemia & Lymphoma Society in recognition of the recent FDA approval of Abecma®. The lentiviral vector used to engineer patients’ T cells was manufactured at Thermo Fisher’s viral vector manufacturing site in Cambridge, Mass. The FDA approval provides the site with a commercial license for viral vector manufacturing.
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Thermo Fisher Acquires Henogen S.A.
To accelerate demand for cell and gene vaccines and therapies globally, Thermo Fisher and Groupe Novasep SAS (Novasep) announced that Thermo Fisher has acquired Henogen S.A., Novasep’s viral vector manufacturing business in Belgium. With two locations in Seneffe and Gosselies, Belgium, Novasep’s viral vector business has more than 7,000 m2 of state-of-the-art clinical and commercial manufacturing capacity and approximately 400 employees with substantial operational and technical expertise in a broad range of viral vector classes.
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Thermo Fisher to Expand Plasmid DNA Manufacturing
To accelerate commercialization of plasmid-based medicines and vaccines, Thermo Fisher is constructing a new cGMP plasmid DNA manufacturing facility in Carlsbad, CA. The new site will expand the company’’s clinical and commercial capabilities for cGMP plasmid DNA used as a critical raw material to develop and manufacture cell and gene-based therapies including life-saving cancer treatments and mRNA vaccines. The site will also have the capability to produce large-scale plasmid DNA as a primary drug substance for DNA therapies.
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Thermo Fisher Expands Clinical Supply Chain Services in Europe
To meet accelerating demand for robust clinical supply chain services throughout Europe, Thermo Fisher has expanded its pharma services footprint with two new state-of-the-art facilities in Rheinfelden and Weil am Rhein, Germany. The new sites will bring much-needed clinical supply chain continuity and specialized cold chain and cryogenic expertise across Europe and globally. These new facilities feature innovative and highly automated technologies to optimize efficiency and quality across the pharma services supply chain.
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Thermo Fisher to Expand Global Steriles in North America and Europe
To meet the rapidly growing global demand for injectable sterile drugs, Thermo Fisher is further expanding its pharma services footprint in North America and Europe for sterile drug product development and commercial manufacturing of critical medicines, therapies and vaccines. Over the next two years, expansion projects at our sites in Greenville, NC, Ferentino and Monza, Italy, and Swindon, UK, will add 15 development and commercial production lines to support a range of capabilities, including live virus, aseptic liquid and lyophilized vial filling, to further enhance our global steriles network.
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