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April 25, 2017

GE Healthcare FlexFactory Selected for UBP's Taiwan mAb Facility

  • United BioPharma (UBP) will use GE Healthcare’s FlexFactory manufacturing platform at its new facility in Taiwan’s Hsinchu Industrial Park, focusing on late-stage clinical and commercial production capacity of therapeutic monoclonal antibodies, the companies said today.

    FlexFactory is a centrally automated, flexible biomanufacturing platform designed to allow manufacturers to quickly and easily establish biopharmaceutical manufacturing capacity within an existing building or as part of a new facility. FlexFactory consists primarily of single-use technologies and associated process hardware and is integrated with automation and control components for start-to-finish manufacturing of biopharmaceuticals.

    UBP’s new facility will be dedicated to late-stage clinical and commercial production capacity of biopharmaceuticals—specifically the anti-CD4 monoclonal antibody UB-421, an HIV treatment that targets the CDR2 region close to domain 1 of the CD4 molecule, the major binding site of the virus.

    UBP said the platform will help it accelerate development of biopharmaceuticals for Taiwan and surrounding markets, as well as open additional global markets to the company. To that end, UBP added, it will also work closely with GE to establish a contract development and manufacturing organization (CDMO) business.

    “The completion of this state-of-the-art facility equipped with two of GE’s 2000-liter single-use bioreactors and integrated manufacturing process is a much-anticipated achievement for UBP to enter into commercial-scale current Good Manufacturing Practice (cGMP)  production with international standards,” UBP Chairperson Chang Yi Wang, Ph.D., said in a statement. “It also resolves the manufacturing bottleneck for UBP’s rich pipeline.“

    With expansion potential to 12 2000-liter production lines within the eight-story facility building, UBP will continue to be the largest protein drug manufacturer in Taiwan in the foreseeable future, Dr. Wang added.

    UBP’s partnership with GE started as a “Fast Trak” collaboration, in which GE Healthcare’s Fast Trak centers provided large-scale equipment and process-related support for UBP’s R&D team members in developing new biopharmaceuticals. The collaboration helped manufacture clinical material, and technology transferred the manufacturing process back to the UBP team in Taiwan during construction of the facility.

    The project has won unspecified support from the government of Taiwan as part of its ongoing effort to advance biopharma—including bioprocessing.

    In a statement, Taiwan’s Industrial Development Bureau (IDB) within the Ministry of Economic Affairs (MOEA) said: “In order to improve the industry’s protein drug technology and commercialization capability, the MOEA will assist, through Industry Collaboration Programs, to bring in and transfer GE Healthcare’s process optimization and scale-up technology for monoclonal antibodies to United BioPharma.”

    “We expect that the successful operation of this plant will further enhance global competitiveness of Taiwan’s protein drug industry. We believe this will become the driving force for the growth of Taiwan’s biotechnology industry,” the IDB stated.

  • GE Healthcare, Lantheus Finalize Up-to-$65M+ Deal

    Separately today, GE Healthcare said it signed a definitive license agreement with Lantheus Medical Imaging for the continued Phase III development and worldwide commercialization of Lantheus’ flurpiridaz F 18, a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent for diagnosing coronary artery disease.

    The definitive agreement follows the signing of a term sheet announced by the companies on February 21. GE Healthcare agreed to take over all funding for the program, including a second Phase III study and global commercialization. Priority territories include the U.S., Canada, Europe, and Japan.

    Lantheus will receive $5 million upfront and up to $60 million tied to achieving regulatory and sales milestones, plus sales royalties. The Lantheus Holdings subsidiary would also retain an option to co-promote flurpiridaz F 18 in the U.S.

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