United BioPharma’s FlexFactory supports a rich pipeline of innovative protein drugs including UB-421, an entry inhibitor monoclonal antibody for HIV treatment
CHALFONT ST. GILES, UK and HsinCHu, TAIWAN– 25 April 2017 – United BioPharma Inc. (UBP) has selected GE Healthcare’s FlexFactory manufacturing platform to 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, whilst 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, pharma and medical devices industry in the country.
The new facility, including GE’s FlexFactory based on integrated single-use technologies, will be dedicated to late-stage clinical and commercial production capacity of biopharmaceuticals, especially a 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 organization (CDMO) business.
Dr. Chang Yi Wang, Chairperson of UBP, said: “The completion of this state-of-the-art facility equipped with two of GE’s 2,000 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. It also resolves the manufacturing bottleneck for UBP’s rich pipeline. With the potential expansion to twelve 2,000-liter production lines within this 8-story 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 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 (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.”
Sven Henrichwark, General Manager, Global Commercial BioProcess, GE Healthcare Life Sciences, said: “UBP’s Flex Factory will help deliver increased capacity as well as supporting Taiwan’s growing pharma 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 their advanced laboratories, provided large scale equipment and process related support for UBP’s R&D team members in developing new biopharmaceuticals. The collaboration , under the Industrial Cooperation Program, 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 over 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 and analytical development, process scale-up. Also, manufacture of drug substances for use in toxicology studies or Phase I and II clinical testing is possible in the Fast Trak Center located in the USA.
GE Healthcare has Fast Trak Service Centers in South Korea, the USA, Sweden, India, and China and satellite Fast Trak Centers in Turkey, Japan and Singapore. Worldwide, more than 500 customers attend standard Fast Trak courses every year, with training available in local languages. In addition, there are customized courses that are built upon request and tailored according to customer needs.
About United BioPharma
Founded in October 2013, United BioPharma (UBP) was spun-off from its parent company, United Biomedical, Inc., 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 commercialization 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. For additional information about the company, please visit www.unitedbiopharma.com.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.