FUJIFILM Diosynth Biotechnologies Signs Manufacturing Supply Agreement with TG Therapeutics

Holly Springs, North Carolina site to provide security of supply for B-cell therapy for relapsing multiple sclerosis


HOLLY SPRINGS, N.C., Nov. 04, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Diosynth Biotechnologies (the Company), a world leading contract development and manufacturing organization (CDMO) for biologics, vaccines, advanced therapies, and oncolytic viruses, today announced that TG Therapeutics, Inc. (NASDAQ: TGTX) has committed to a multi-year manufacturing supply agreement for BRIUMVI® (ublitiximab-xiiy), its U.S. FDA-approved therapeutic for relapsing forms of multiple sclerosis (RMS).

Under the terms of the manufacturing supply agreement, FUJIFILM Diosynth Biotechnologies will provide secondary US-based manufacturing supply for BRIUMVI at the Company’s new biopharmaceutical manufacturing facility in Holly Springs, North Carolina, which is set to be fully operational in 2025.

“This commitment recognizes the expertise, capacity and capabilities that FUJIFILM Diosynth Biotechnologies provides with our fully integrated manufacturing network,” said Lars Petersen, president and chief executive officer, FUJIFILM Diosynth Biotechnologies. “FUJIFILM Diosynth Biotechnologies is executing an aggressive expansion strategy, providing customers access to our manufacturing network across the United States, Europe, and Japan for the purpose of meeting the growing demand for biotherapeutics and ultimately making patients’ lives better.”

Michael S. Weiss, chairman and chief executive officer of TG Therapeutics stated, “We are excited to partner with FUJIFILM Diosynth Biotechnologies as a secondary manufacturer of BRIUMVI here in the United States, and believe their expertise makes them an ideal partner for us. As we expand our commercialization efforts in MS and think about the future for BRIUMVI, we believe this is an important next step that will continue to support our growth plans and provide additional security for the supply of BRIUMVI.”

Additional details will not be disclosed.

About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization partner for the development and manufacture of biologics, vaccines, cell and gene therapies, and oncolytic viruses. The company operates a global network with major locations in the United States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacture of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. For more information, go to: www.fujifilmdiosynth.com.

About FUJIFILM Holdings Corporation
 FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: www.fujifilmholdings.com

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