SUZHOU and HANGZHOU, China, March 17, 2021 - Transcenta, a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, today announced a major breakthrough in its continuous perfusion cell culture platform by achieving volumetric productivity of > 6 g/L per day while maintaining process and product quality attributes in a state of control for a 4-week culture. This productivity improvement represents a 15-fold increase in drug substance output per year when compared to same cell line in conventional fed-batch process (6 g/L over 14 days). At such high productivity, one 100L or 1,000L single use bioreactor can produce approximately 130 kg or 1.3 metric tons of total drug substance per year, respectively, in a multi-product single-use facility. 

"This is an important milestone as it demonstrates the power of our 'plug and play' fast to develop perfusion platform to support ongoing development of our stable and less stable protein therapeutics." said Dr. Chris Hwang, Chief Technology Officer at Transcenta. "Even with this exciting result, I believe there is still upward potential since the media and the process are not yet optimized."

Transcenta is developing single-use Integrated Continuous Bioprocessing platform (ICB) because it has the potential to offer speed, cost efficiency and robustness needed for Transcenta to be highly competitive and successful in fulfilling its mission to deliver high quality and affordable innovative biologics to patients around the world. While continuous perfusion is a key component of its ICB technology, to address downstream and future facility bottlenecks, Transcenta has formed a multi-year strategic technology collaboration with Merck KGaA, Darmstadt Germany in June 2020 to develop automated continuous downstream equipment and other key enabling technologies in support of GMP manufacturing.

"We are making significant progress in developing technology for unlocking the full potential of our platform," added Dr. Chris Hwang. "With continued investment in technology and support from our partners, I anticipate our end-to-end continuous and automated ICB technology will be fully operational within two years in our T-BLOC facility and ready to support clinical development and commercial launch. This will enable us to provide 'economies of scale' output in a relatively small and low cost modular facility that was fast to build and to expand, and provide low cost of goods, high flexibility and expandability which will ultimately benefit our patients."