TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
Transcenta’ s GMP production facility in Hangzhou Biopharma Town is designed with a modular concept with independent intellectual property rights. The modular GMP facility, which we refer to as T-BLOC, offers high flexibility and scalability, which can significantly reduce the cost of producing condition reconfiguration. Taken the product safety and process stability into consideration at the start of the design, the upstream, downstream, and steps before/after viral reduction are separated into different areas. The whole production process adopts disposable technology, which can effectively avoid the risk of cross-contamination in the simultaneous production of multiple products.
Its current capability include DS and DP manufacturing for Toxicology Studies, Phase I, Phase II and Phase III clinical trials with destined manufacturing of commercial products up to 1000kg protein output p.a..
To maximize facility output with significant lower cost of goods, improve process robustness and minimize operational risks, we are developing and implementing a continuous manufacturing platform called Highly Integrated Continuous Bioprocessing (HiCB), where a proprietary and highly productive continuous upstream perfusion process will be integrated with an automated and continuous downstream process that we are co-developing with Merck. By leveraging the power of ultra-high cell density continuous perfusion process and our proprietary cell culture media, we have demonstrated industry leading volumetric productivities of over 7 g/L-day and output increases for multiple cell lines of up to 10 to 20-fold when compared to conventional fed-batch processes.
Transcenta’s manufacturing facility currently has multiple 200~2000L DS production lines and a fully automated drug product filling line with isolators, and reserved space for expansion of its production line. It is expected to have an annual capacity of over one ton (1,000 kg/year) in the future. In operation for 4 years up to the first quarter of 2022, this GMP production facility has 100% successfully undertaken more than fifty batches of internal and external projects.
In anticipation of an increase in the product demand in the future, Transcenta has also initiated the construction of the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park, of which the adjustable annual capacity achieves beyond three metric tons.