Pre-clinical research platform

BlissBio has established a preclinical research platform for innovative biologics with a complete technology chain, including the design and screening of lead antibodies, genetic engineering of antibodies for site-specific conjugation, and the design and screening of payloads and linkers. Techniques such as BLI, ELISA, FACS, and endocytosis are used to evaluate the affinity, specificity, and cell-based bioactivity of lead antibodies and genetically engineered antibodies, as well as the conjugation process. Ultimately, innovative biologics with high commercialization potential are developed, following evaluation of ADC stability, cytotoxicity, in vivo efficacy, and safety.

BlissBio has established a high-throughput, high-quality process development platform for the entire life cycle of innovative biologics, including the evaluation of candidate molecules, the development of high-producing single clones, the development and scale-up of cell culture, purification, conjugation, and drug product manufacturing processes, as well as support for GMP manufacturing. With a high-throughput screening platform and the high-producing expression system, high producer cell lines can be developed with confirmed monoclonality, stability, and desired product quality. After selecting the lead single clones, the cell culture process and purification process can be developed using glass bioreactors, Ambr250, and AKTA system.

Process development platform

Quality research platform

The quality research platform of BlissBio has the capability to analyze the physicochemical and biological properties of innovative biologics. The structure, post-translational modifications, purity, impurities, and biological activities of biologics are characterized by high-resolution LC-MS, molecular interaction analyzer, automatic CE-SDS, UPLC, and multi-functional ELISA. This mature platform can meet the requirements for drug developability evaluation, process development, and product quality research for antibodies and ADCs.

BlissBio has established pilot-scale and commercial-scale GMP manufacturing platforms, as well as a quality system that meets the requirements of FDA, EMA, and NMPA, enabling the quality control and audit of the entire manufacturing process. Based on leading automation techniques and a digital management system, this platform can produce mAbs and ADCs with high efficiency and stability.

GMP manufacturing platform