TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
Innovation
The IMTB technology platform, enables us to generate antibodies to both non-conserved and conserved proteins, which are difficult to generate in rodents, and to discover hidden epitopes that are challenging to discover using conventional platforms. This allows us to obtain lead candidate antibodies with expanded epitope diversity, differentiated pharmacology properties and robust CMC profiles, resulting in selecting candidate molecules with enhanced druggability attributes and strong intellectual property position. Leveraging this IMTB technology platform, we have generated Osemitamab (TST001), TST005, TST003, TST004, TST010, TST012, TST013, TST008, TST801, etc.,
Our translational research generates PK, PD, Tox and immunogenicity data through validated quantitative platforms, and enables us to model clinical responses to our investigational agents for better understanding of PK/PD/Safety profiles, which guides design and conduct of clinical studies. We provide scientific inputs to best-in-class drug candidate selection and provide assessment of combination therapies with agents targeting different disease signaling pathways. We have platforms that allow us to generate and screen antibodies for target-detection using immunohistochemistry and to develop companion diagnostic assays for patient selection and stratification in clinical trials, which improves trial success by enrolling patients with high probability of response to the drug treatment in selected indications.
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.
Transcenta has a highly capable and well-rounded CMC development team covering all technical aspects of biologics development. By effectively balancing speed, quality and cost, the team can rapidly advance promising drug candidates toward IND filings and clinical development.
In terms of manufacturing processes, Transcenta has established its HiCB (Highly Intensified Continuous Bioprocessing) platform. It replaces stop-and-go batch processing with 30-day continuous perfusion, where cells are maintained at high densities in a tightly controlled and optimized environment, delivering 10–15x productivity gains.
Perfusion is especially advantageous for certain less stable bispecifics, multispecifics and other complex formats, helping reduce degradation or aggregation while ensuring product quality and batch-to-batch consistency. Complementing continuous perfusion upstream, the platform adopts a hybrid continuous downstream approach to improve efficiency and maximize facility output while remaining robust and easy to implement.
Leveraging our global expertise and footprint, we adopt a global approach to maximize operational efficiency. Concurrently, we leverage the efficient regulatory approval pathway to accelerate IND applications and early-phase clinical trials in the United States and to advance the execution of clinical trials in the indications with highly unmet medical needs from the large patient population in China. We design the trials that allow clinical data from each trial to be used for pooled analysis and for the use of supporting global registration. In addition, clinical data from multi-regional clinical trials will enable future indication expansion for the drug(s) investigated. Based in Beijing, Shanghai, Guangzhou and Princeton, US, our global clinical development and regulatory teams have extensive knowledge and experience in designing and executing clinical trials at all stages in indications with significantly unmet medical needs globally.
