Transcenta, a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D, regulatory affairs and manufacturing, today announced it has achieved a major milestone in its continuous perfusion cell culture platform by achieving volumetric productivities of > 4 g/L per day for multiple cell lines expressing monoclonal antibodies. 

This is a significant milestone and Transcenta achieved this using in-house developed chemically-defined media, robust cell line expression system as well as its extensive technical expertise in continuous bioprocessing.  By applying such platform process, one 500L single use bioreactor can produce more than 400kg of total drug substance per year for single product or multiple products combined which is approximately 10-fold greater than conventional fed-batch processes at 5 - 6 g/L.  Furthermore, with ease and speed of perfusion development together with minimum or no scale up from pilot tox to GMP manufacturing, one can ensure consistent product quality and speed to clinic and commercial while reducing potential risks associated with tech transfer and scaling up.  In addition, this can lead to significant reduction in the cost of goods for biologics.  Transcenta is applying this perfusion platform to internal pipeline programs and will make it available for business partners.

“Perfusion technology has been used to produce biologics since early 1990’s but mainly for production of labile and harder to manufacture proteins.  However, at Transcenta, we are dedicated to intensify this technology to develop a highly productive platform that is fast to develop and can be applied to any protein biologics with enhanced product quality control.  Furthermore, when integrated with our end to end continuous and automated downstream platform that is under development, our Integrated Continuous Bioprocessing (ICB) platform operating in our highly flexible and efficient modular manufacturing facility T-BLOC, it will help to realize our mission of employing cutting-edge technology to deliver high quality innovative biologics at affordable price to patients around the world.” said Dr. Chris Hwang, CTO of Transcenta.  “I’m so proud of our team in achieving this important milestone in mere 12 months of development and I firmly believe there is still significant upward potential and is excited with what is yet to come.” 

“With drug pricing and affordability at the top of the agenda of the pharmaceutical industry, it is critical to be able to shorten the development cycle and reduce the cost of goods for biological products.  The ability to combine continuous bioprocessing technology with our modular manufacturing facility T-BLOC to ensure drug supply is a significant competitive advantage for Transcenta. Transcenta is committed to employing cutting edge technology like ICB to deliver affordable high quality innovative biologics to patients around the world.” added Xueming Qian, CEO of Transcenta.