United BioPharma (UBP) has selected GE Healthcare’s FlexFactory manufacturing platform for its new facility focusing on late-stage clinical and commercial production capacity of therapeutic monoclonal antibodies in Hsinchu Industrial Park, Taiwan.
With this added capacity, UBP will support local healthcare needs by bringing biopharmaceuticals to the Taiwanese and surrounding markets faster, while also opening global markets through the FlexFactory’s proven track record in meeting global regulations and quality standards.
The project received support from the Taiwanese Government to help improve access to biopharmaceuticals and boost the bioprocess market in the region. This is a key priority for the Taiwanese Government, which has introduced several policies to create a favorable environment for the development of the biotech, pharmaceutical, and medical devices industries in the country.
Including GE’s FlexFactory based on integrated single-use technologies, the new facility will be dedicated to late-stage clinical and commercial production capacity of biopharmaceuticals, especially monoclonal antibody UB-421, which will be used for HIV treatment. GE will also continue to work closely with UBP on the establishment of its contract development and manufacturing organisation (CDMO) business.
Chairperson of UBP Dr. Chang Yi Wang said: “The completion of this state-of-the-art facility equipped with two of GE’s 2,000l 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.
“It also resolves the manufacturing bottleneck for UBP’s rich pipeline. With the potential expansion to twelve 2,000l production lines within this eight-storey building, UBP is and will continue to be the largest protein drug manufacturer in Taiwan in the foreseeable future.”
The head of Taiwan’s Industrial Development Bureau (IDB), Ministry of Economic Affairs (MOEA), said: “In order to improve the industry’s protein drug technology and commercialisation capability, the MOEA will assist, through Industry Collaboration Programmes, to bring in and transfer GE Healthcare’s process optimisation and scale-up technology for monoclonal antibodies to United BioPharma (UBP).
“Through this, we will indirectly assist the establishment of UBP’s 2,000l x 2 biologics manufacturing plant. 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.”
General manager of global commercial bioprocess at GE Healthcare Life Sciences Sven Henrichwark said: “UBP’s Flex Factory will help deliver increased capacity and support Taiwan’s growing pharmaceutical industry requirements more rapidly. Taiwan’s desire to boost its manufacturing capacity is an industry need we are hearing echoed across the globe.
“Local production capability is a crucial element in providing national healthcare systems with the vital medicines to address growing patient needs. We are excited to contribute to UBP’s development by delivering a robust and flexible biomanufacturing solution that includes final qualification and training.”
UBP’s partnership with GE started as a Fast Trak collaboration. GE Healthcare’s Fast Trak centers, with advanced laboratories, provided large-scale equipment and process-related support for UBP’s research and development (R&D) team members in developing new biopharmaceuticals. The collaboration under the Industrial Cooperation Programme helped manufacture clinical material and technology transferred the manufacturing process back to the UBP team in Taiwan with complete transparency, while their facility was being built.
GE Healthcare’s FlexFactory is a centrally automated, flexible biomanufacturing platform. It allows manufacturers to quickly and easily establish biopharmaceutical manufacturing capacity within an existing building or as part of a new facility.
FlexFactory is designed to help manufacturers such as United BioPharma to rapidly respond to local healthcare needs and to support global customers in bringing lifesaving treatments to market more quickly, FlexFactory is primarily comprised of single-use technologies and associated process hardware and integrated with automation and control components for start-to-finish manufacturing of biopharmaceuticals.
About Fast Trak
GE’s Fast Trak Service Centers are specifically designed to help biopharmaceutical manufacturers increase their process productivity, reduce cost, and enable them to bring their products to market faster. The centers are equipped with the latest technologies for bioprocessing in an environment and at a scale that closely replicates the real-life industrial setting.
For more than 30 years, thousands of customers world-wide have been trained by GE’s experienced Fast Trak leadership teams, giving customers access to industry expertise encompassing process, analytical development, and process scale-up. Manufacture of drug substances for use in toxicology studies or Phase I and II clinical testing is also possible in the Fast Trak Center located in the US.
GE Healthcare has Fast Trak Service Centers in South Korea, the US, Sweden, India, and China, as well as satellite Fast Trak Centers in Turkey, Japan, and Singapore. More than 500 customers worldwide attend standard Fast Trak courses every year, with training available in local languages. In addition, there are customised courses that are built upon request and tailored according to customer needs.
About United BioPharma
Founded in October 2013, UBP was spun-off from its parent company United Biomedical Asia to focus on its monoclonal antibody drugs business.
UBP has established a strategic partnership with Taiwan conglomerate Formosa Plastics Group and its Chang-Gung Memorial Hospital network. UBP possesses a comprehensive technology platform for antibody drug development and is focused on the R&D, manufacture, and global commercialisation of innovative monoclonal antibodies and biosimilar antibodies with significant market potential.
Driven by innovation and execution, UBP strives to provide effective therapeutics to address unmet medical needs, improve human health and contribute to Taiwan’s economic development