Image Credit: Thermo Fisher Scientific
Thermo Fisher Scientific, a contract development and manufacturing organization (CDMO), has opened a new clinical and commercial ultra-cold facility in the EU,1 which not only grows its European clinical trial network, but helps speed up advanced therapy development. The new current good manufacturing practice (cGMP) facility in Bleiswijk, Netherlands offers both pharma and biopharma clients end-to-end support throughout the clinical supply chain for high-value therapies, including antibodies, biologics, cell and gene therapies (CGTs), and vaccines.
The plant was constructed in order to address the rise in demand from European CGT clinical trials in Europe; in fact, says the CDMO, it builds on the company’s current bioservices and specialty logistics services, including biorepository solutions and critical material storage. The facility enables customers to meet clinical trial requirements regardless of scale or phase.
“The opening of this cutting-edge facility supporting the development of cell and gene therapies and other biologics, coupled with our proven track record in managing valuable materials, places us in an unmatched position to help our global clients develop innovative therapies,” said Molly Flick, vice president and general manager, bioservices & specialty logistics, Thermo Fisher Scientific.
Having said that, the site is about 30 minutes outside of Amsterdam, providing clinical and commercial packaging services for CGT products from development to commercialization, as well as the aforementioned end-to-end biorepository storage solutions and associated supply chain services. Capabilities include 54,000 square feet of ambient to cryogenic storage, ancillaries, and cold chain packaging, labeling, and distribution, along with clinical qualified person (QP) release services.
From a sustainability standpoint, Thermo Fisher is commited to achieving net-zero emissions by 2050. As a result, the Bleiswijk site uses 15% solar power and runs completely gas-free, offers sustainable heating and cooling with eco-friendly electric heat pumps, and uses ultramodern heat recovery technology.
Among the news, Thermo Fisher also recently expanded its biologics manufacturing capacity in St. Louis,2 opened a new cell therapy manufacturing facility in San Francisco,3 and unveiled its TSX Universal Series ULT Freezers, which are reportedly able to acclimate to scientists’ workflows across multiple lab settings.4
“With the advancement of new therapeutic technologies and tighter regulatory focus on the pharmaceutical cold chain, there’s a clear need for enhanced and manageable cold storage solutions across a variety of settings,” said Carlos Sevilla, VP and general manager, controlled temperature technologies at Thermo Fisher Scientific. “Following extensive research and development, we’re proud to launch the next generation TSX Universal Series of ULTs, enabling high-use academic labs, [good manufacturing labs] GMP labs and long-term storage facilities to use the same unit throughout diverse workflows while supporting their own sustainability goals.”
References
1. Thermo Fisher Scientific Opens New GMP-certified Ultra-cold Facility in the EU to Accelerate Advanced Therapies Development. Thermo Fisher Scientific. June 3, 2024. Accessed June 3, 2024. https://newsroom.thermofisher.com/newsroom/press-releases/press-release-details/2024/Thermo-Fisher-Scientific-Opens-New-GMP-certified-Ultra-cold-Facility-in-the-EU-to-Accelerate-Advanced-Therapies-Development/default.aspx
2. Thermo Fisher Scientific Expands St. Louis Manufacturing for Complex Biologic Treatments. Business Wire. October 5, 2023. Accessed June 3, 2024. https://www.businesswire.com/news/home/20231005422767/en/Thermo-Fisher-Scientific-Expands-St.-Louis-Manufacturing-for-Complex-Biologic-Treatments
3. Kurtzman L. Thermo Fisher Scientific Expands St. Louis Manufacturing for Complex Biologic Treatments. University of California San Francisco. March 27, 2023. Accessed June 3, 2024. https://www.ucsf.edu/news/2023/03/425016/thermo-fisher-scientific-opens-cell-therapy-facility-ucsf-accelerate
4. Saraceno N. Thermo Fisher Scientific Introduces New Ultra-Low Temperature Freezer. Pharmaceutical Commerce. May 24, 2023. Accessed April 8, 2024. https://www.pharmaceuticalcommerce.com/view/thermo-fisher-scientific-introduces-new-ultra-low-temperature-freezer