We offer services in the preparation of GMP Master and Working Cell Banks with all necessary monitoring and documentation to meet regulatory requirements (ICH Q5D).
We collaborate with BioReliance for master and working cell bank characterization and qualification.
Good security practices are soundly executed for storage and management of client’s cell banks.
Our state-of-the-art GMP Biologics Manufacturing Facility is designed and established to meet global regulatory requirements and employ the latest single-use manufacturing technologies, allowing for short turn-around time and high flexibility.
We offer GMP biologics API manufacturing services for preclinical and clinical trial use.
GMP drug product filling
We have established international GMP compliant small volume parenteral injectable product filling lines, which were certified by PIC/S GMP, US FDA, TGA, INVIMA and PMDA. The capacities for the injectable productions are as follows:
‧vial： 1mL to 25mL (24 million vials/year)
‧ampoule：1mL to 20mL (24 million amp/year)
We also established a lyophilization production line with the capacity of:
‧20,000 x 2ml/batch
‧10,000 x 10 ml/batch
CMC and Dossier document preparation
With abundant international regulatory submission experiences, we also provide CMC and Dossier document preparations in compliant with most updated regulation requirements.
Located in Hsin Chu Industrial Park, Taiwan, our Biologics Pilot Plant encompasses 9,000 square feet of manufacturing area and maintains stainless steel (SS) stirred-tank bioreactor systems, recovery, purification systems, and clean room work zones of grade B, C and D. The facility is supported by a dedicated HVAC system, Water for Injection and clean steam systems. This integrated facility consists of a 30L SS bioreactor and two 150L SS bioreactor systems, one suite of recovery and purification systems, and clean room work zones up to grade B for terminal filter sterilization and GMP cell banking.
The Biologics Pilot Plant was designed, built and validated to comply with cGMP requirements for biologics and active ingredient production. The cGMP status was approved by Department of Health (DOH), Taiwan in 2007, 2009, 2011. Since 2009, this pilot GMP facility has supported all protein drugs in UBI’s pipelines for pre-clinical and clinical trials.
Biologics plant‧Industry scale
Our world-class, state-of-the-art industrial scale Biologics Manufacturing Facility located in Hsin Chu, Taiwan, is equipped with FlexFactory®, which is a hybrid single-use biomanufacturing platform that provides complete production train from cell culture to drug substance formulation. Process equipment for distinct processing steps is set up as operational units connected via disposable tubing sets. Each unit is centrally controlled and monitored by a 21 CFR Part 11 compliant automation system. Extensive use of single-use process equipment simplifies production change-over procedures, enables rapid setup and scalable production. This facility is designed to be compliant with PIC/S, US and EU pharmaceutical quality standards.
The upstream operation unit is equipped with Single-use bioreactors from 100L to 2,000L working volume and 5:1 turn down ratio, when operating between 20%-100% of the bioreactor volume. The manufacturing capacity of this facility is expandable up to 12 x 2000L.
The downstream purification train features a series of ÄKTA chromatography systems (1” SS gradient), flexible depth filtration for harvest, virus filtration, Auto ultrafiltration/diafiltration (UF/DF), and Bulk dispensary system (BDS).
Both the upstream and downstream process trains are supported by a complete series of mixers and totes such as buffer holding tanks. These mixers and totes are matched to function and are specified with necessary features such as pH, conductivity and temperature control as needed. For intermediate product holding tanks, a robust, versatile and easy-to-use single-use mixer with high accuracy and consistency in temperature control capability is utilized to secure the product quality in large-volume mixing operations, e.g. 2,000L~ 2,500L.
cGMP Pharmaceutical facility
The high-quality cGMP Pharmaceutical Manufacturing Facility, located in Hsin Chu, Taiwan, is certified by Taiwan DOH for PIC/S GMP compliance. In addition, it has been inspected by Japan PMDA, Australia TGA, and Columbia INVIMA as qualified contract manufacturer. The injectable production line was inspected by U.S. FDA for cGMP compliance in 2013, and obtained for approval.