United BioPharma successfully completes Taiwan FDA GMP inspection for its 2000L commercial scale manufacturing facility
that its newly constructed 2000L commercial scale biologics manufacturing facility in Hukou, Taiwan has been successfully inspected by Taiwan Food and Drug Administration (FDA) and granted with PIC/S GMP certificate.
This PIC/S cGMP certification marks a new milestone that UBP has been moving forward and laid a solid foundation for its capability of GMP manufacturing of biopharmaceuticals in commercial scale.
The construction of UBP’s 2000L-scale biopharmaceutical production facility follows the highest international standards and is equipped with state-of-the art instruments and computer-driven process control. Currently two 2,000L production lines are installed at UBP’s protein drugs manufacturing facility. Additional spaces are reserved for future expansion of up to 12 production lines. UBP adopts single-use manufacturing technology, an emerging global trend for biopharmaceutical products.
The PIC/S GMP certification of UBP’s protein drug manufacturing facility is an important accomplishment, allowing the company to supply protein drug candidates for late stage clinical trials, such as for the company’s leading product UB-421 which is entering multi-regional phase 3 trial for treatment of HIV. The Contract Development and Manufacturing Organization (CDMO) business accounts are also being developed based on the Company’s solid-built fully integrated development and manufacturing technologies and state-of-the-art facility.
United BioPharma (UBP) is a multi-national clinical-stage biopharmaceutical company dedicated to the research, development and manufacture of innovative and biobetter monoclonal antibody therapeutics for treatment of infectious, cancerous and immunological diseases. With R&D and manufacturing conducted at UBP’s headquarters in Hsinchu Industrial Park (Hukou), clinical research centered at the laboratories in Hsinchu Biomedical Park (Zhubei), and business operations at offices at Taipei 101, UBP is effectively positioned to employ its cutting edge and solid integrated technology platform and utilize its state-of-the-art research and manufacturing facilities to address unmet medical needs in mankind and to improve patient health and quality of life. UBP has its liaison offices in Long Island, New York; a research base for clinical development and regulatory affairs in Shanghai; a clinical laboratory, and pilot as well as commercial scale protein drug GMP manufacturing facilities currently being established in Yangzhou, China.
Vice President, CMC Center