Thursday, September 26, 2019

Thermo Fisher Scientific Expands Clinical Trials Capabilities and Announces Collaboration with Frontier Biotechnologies Inc.

          Expanded facility provides faster access to market for customers conducting clinical trials

          Drug development collaboration strengthens commitment to patients

          Thermo Fisher Scientific, the world leader in serving science, announced today an expansion of its integrated clinical trials supply and distribution services network, in Suzhou, China, as well as a collaboration with Frontier Biotechnologies Inc. to develop a novel treatment for human immunodeficiency virus (HIV).

          Thermo Fisher operates the largest contract development manufacturing organization (CDMO), offering drug substance, drug development, clinical trials, drug product and viral vector development and manufacturing solutions to companies of all sizes. The company is investing more than $270 million globally in 2019 to expand its capabilities, increase capacity and recruit and retain talent, strengthening its ability to enable our customers to deliver the highest quality medicines to patients around the world.

          About the new Clinical Trials Facility

          To align with China's effort to encourage drug innovation, the newly expanded Suzhou facility will address the growing demand for drug development supply chain services and focus on high quality primary and secondary packaging solutions for customers and their patients. The facility will support the growth of clinical trial studies for customers in China and provide emerging biotech companies with the resources to develop and commercialize new drug candidates.

          The nearly 7,000-square-meter addition in Suzhou offers a full suite of services, including materials storage, packaging and distribution. The expansion adds new Beta Lactam storage, 10 to 20 degrees Celsius storage and cold chain capacity and increases current storage capacity for temperatures at 15 to 25 degrees Celsius, 2 to 8 degrees Celsius and -20 degrees Celsius. With a nearly $4.4 million investment, the Suzhou facility will become Thermo Fisher's largest clinical trials facility in the region. It is also China's only provider of over-encapsulation service, which is widely used in blinding supplies in local and global clinical studies. The facility also adds label printing for high- quality standard and variable print capabilities to increase productivity and improve time to market.

          As part of the opening ceremony, a roundtable discussion took place among government officials, industry experts and academic scholars to share insights and discuss trends in drug labeling as well as advances being made in China to improve patient outcomes.

          "By expanding and strengthening our pharma services capability in Suzhou, we can offer our customers access to our global expertise and a world-class integrated network that focuses on high quality and continuous innovation to serve patients around the world," said Domenic Stranieri, vice president and general manager, Thermo Fisher Clinical Trials business, APAC.

          "The Suzhou clinical trials facility opening is part of a global initiative to expand the company's integrated clinical supply chain network in China with a strategic focus on quality, cold chain logistics and advanced capabilities," said Leon Wyszkowski, president of Thermo Fisher's Clinical Trials business.

          About the Collaboration with Frontier

          Building on its commitment to deliver the highest quality medicines to patients around the world, Thermo Fisher and Frontier Biotechnologies, Inc., a biopharmaceutical company based in China, announced a strategic partnership to accelerate the commercialization of 3BNC117, a novel broad-spectrum HIV neutralizing antibody.

          Thermo Fisher will be the exclusive drug substance manufacturing partner of 3BNC117 to support the pivotal study, process performance qualification (PPQ) and global commercial supply. The product will be manufactured at Thermo Fisher's site in St. Louis, Missouri.

          "The combination of our expanded clinical trials capabilities in Suzhou and collaboration with Frontier, demonstrate our ability to offer our customers solutions to complex drug development challenges at every stage of development, said Michel Lagarde, executive vice president and president of Thermo Fisher's Pharma Services business. "We are looking forward to helping our customers take their molecule from the lab to the market, further enabling them make the world healthier."

          This collaboration will integrate Thermo Fisher's expertise and regulatory track record in biologics drug development and manufacturing, as well as the outstanding innovation capabilities of Frontier in HIV treatment to expedite the commercialization of 3BNC117, to improve treatment for patients with HIV.

          About Thermo Fisher Scientific

          Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.

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