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.
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.
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.
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. 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 planned manufacturing of commercial products up to 1000kg protein annual output.
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 5 years up to the first quarter of 2023, this GMP production facility has 100% successfully undertaken more than fifty batches of internal and external projects.