Manufacturing Capabilities for Mammalian Cell derived Protein and Antibody Drugs
Our Commercial Scale mammalian cell derived Protein Drug Manufacturing Facilities located in HuKo, Hsin Chu, Taiwan received cGMP inspection from Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare in June 2019 with subsequent approval.
This state-of-art facility is equipped with two 2,000 L production lines and can be upgraded to 12 of 2,000 L lines. This facility was designed for PIC/S and international GMP compliance. The implementation of FlexFactory® Single-Use Process Technology (GE Healthcare) is flexible and can be easily switched between batches. Its automatic central monitoring system integrates cell culture, buffer solution injection, and protein purification, optimizing the safety of the product and efficiency of the manufacturing process.
Our protein drug pilot plant, located in Huko adjacent to our commercial scale plant which boasts two 150 L mammalian cell culture based production systems for protein drug API, received Taiwan FDA GMP certification in 2008 and has since completed production for 30 lots of protein/mAbs drug products for pre-clinical and clinical studies.
Similar facilities for mammalian cell produced protein and antibody drugs both at commercial and pilot scales under cGMP compliance have also been established in our Yangzhou High-Tech Industrial Zone ready for opening in mid October, 2019.
R&D and Quality System facilities system CMC(Facilities)
The proprietary integrated protein product development technologies including high-yield cell line construction, cell culture and a purification process, physicochemical and biochemical characterization, high-concentration protein drug formulation, animal pharmacology and pharmacokinetic studies are all conducted in our world-class research and development laboratories based in our HsinChu Center of Excellence in R&D, Taiwan.
Manufacturing Capabilities for our High Precision Designer Peptide based Vaccines
A 45,000 square feet building located in Hauppauge, New York was established more than two decades ago with an FDA establishment license (No. 1079) in 1994 and subsequently an USDA establishment license (No. 620) in 2004 for the production of synthetic peptide based blood screening diagnostics. We further renovated and equipped additional research and development facilities in Hauppauge for the manufacture, under GMP, of our proprietary peptides in larger scales for the production of our high precision designer vaccines for clinical trials and regulatory filing purposes.
In addition, a second facility was established in Huko, Hsin Chu for the manufacture of cGMP grade of our high precision designer peptides and vaccine formulations in a 30,000 square feet building which received EU Quality Personnel approval for clinical trials in EU countries.
Through its joint venture in Taiwan (UBI-Asia), UBI acquired a pharmaceutical operation from GlaxoSmithKline in 2000 with 240,000 square feet of land and 98,000 square feet of multistory manufacturing facilities for the manufacture of human pharmaceuticals in multiple formulations with special emphasis on US bound specialty injectables. This pharmaceutical manufacturing operation has received cGMP approval from US FDA and other regulatory agencies worldwide. The pharmaceutical products manufactured at this site under contracts have been sold in Taiwan, ROC and many other countries worldwide. UBI group also maintain its Asian administrative headquarters in Taipei 101 building in Taiwan, ROC.
Our China operations for animal health vaccines were established in Shanghai in 2004 and expanded in 2006 to four new buildings totaling 168,000 square feet in Shanghai’s premier ZhiZhu Science Park.
This Shanghai base includes facilities for the manufacture of API peptides in Kilogram quantity for manufacturing of animal vaccines and diagnostics, and for R&D support activities. UBI-Shanghai's (aka Shen Lian Biotech) manufacturing facilities were put to immediate use for the production of our UBITh® swine FMD peptide vaccine to meet the demand in China, the world’s largest market for pig healthcare products. Utilizing western standards, this state-of-the-art base in Shanghai gives UBI advantages in large scale, low cost manufacturing of UBI’s proprietary biologics for direct access to the large China market, and allows for a low cost, cutting edge R&D support system. In January 2007, the peptide and vaccine manufacturing facilities were approved by the Ministry of Agriculture, PRC, for GMP compliance for the production of UBI’s proprietary swine FMD vaccine in 1000L, 2000L and 4000L per batch commercial scale as emulsions and multi-kilograms of designer peptides. The ZhiZhu facilities have manufactured over 4 billion doses of our UBITh® swine FMD peptide vaccines over the past decade.
