TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company
Transcenta, biologics, antibody
In Suzhou, China, we have a Discovery, Clinical and Translational Research Center covering over 5,000 square meters. Inside, we put in place a unique and discovery platform based on Immune Tolerance Breaking Technology that enables our world-class team with extensive global experience in biologics discovery to generate antibodies with diverse epitopes.
The strong and competent in-house capabilities have allowed us to develop MSB2311, a 2nd generation PD-L1 antibody characterized by its unique pH-dependent antigen binding and recycling properties. Clinical trial for this asset is ongoing in both China and the US.
To bring more life-changing and affordable antibody therapies, multiple partnerships on discovery and co-development have been established based on this technology.
Process development plays a critical role throughout biopharmaceutical candidate lifecycle from early discovery all the way to post-marketing surveillance, including target validation, genetic engineering, cell line development, cell culture/purification process development, analytical method development, formulation development and GMP manufacture. In the race to IND filing and clinical trials, companies with deep CMC knowledge and capability often find themselves have an edge over their competitors.
In Transcenta, our CMC team comprises competent SMEs from various functions spanning all aspects of biologics development. Supported by Integrated Continuous Bioprocessing Platform, the flexible modular manufacturing facilities and other cutting-edge technologies, we strike a balance among speed, quality and cost to drive our highly druggable candidates through the pipeline into IND filing and clinical trials.
Clinical researches and trials are a critical path in which we answer important scientific questions and gain a better understanding about safety and efficacy of drugs under the investigation, and through which we transform the science to potential treatment opportunities to the patients around the world.
To support Transcenta’s mission of delivering high quality innovative drugs at affordable cost to patients worldwide, our clinical organization takes leadership position and works with KOLs and investigators as well as partners in creating a discipline around the clinical innovation to ensure conducting higher quality of clinical trials with speed and agility. We are driving scientific innovation and deliver the new generation of medicines that target cancers and other disease areas for the patient.
We are proud to distinguish ourselves and lead the industry with our next-generation Biomanufacturing Facility located in Hangzhou, China. Through deployment of multiple 500L and 2000L SUBs for Drug Substance (DS) production of both fed-batch and continuous perfusion technology, and a cutting-edge fill-and-finish line for Drug Product (DP) production, we have realized a fully integrated manufacturing platform. Our single-use based T-BLOC facility is designed to achieve the objectives of flexibility and adaptability in facility design, accelerated IND and BLA submission, cost-conscious of manufacturing, and never compromising product quality. Its current capability include DS and DP manufacturing for Tox, Phase 1, Phase 2 and Phase 3 clinical trials with destined manufacturing of commercial products up to 1000kg protein output p.a..