On January 9, Bora Pharmaceuticals announced that its subsidiary, Bora Biologics, has entered into a strategic partnership with Singapore-based DotBio to accelerate the development of the critical Chemistry, Manufacturing, and Controls (CMC) process for DotBio’s novel trispecific antibody drug candidate, DB007, designed for cancer treatment.
DotBio, a company specializing in next-generation antibody therapies, employs rapid prototyping methods to develop multifunctional and intracellular antibodies with synergistic effects, optimal structures, and unique mechanisms of action. DotBio boasts a diverse platform and a growing portfolio, including various DotBody modules targeting specific markers, a licensed clinical-stage program (JS207), and multiple trispecific antibody candidates in preclinical development.
Bobby Sheng, Chairman and CEO of Bora Pharmaceuticals, stated that Bora Biologics’ R&D and manufacturing center, located in Zhubei City, Hsinchu, Taiwan, spans 4,500 square meters (approximately 48,400 square feet). This facility will support DotBio’s core product by providing essential CMC strategies to ensure a smooth transition to the clinical development stage.
The facility offers early-stage drug development support, including candidate molecule screening, in vitro assays, biochemical and physical analyses, as well as the preparation and purification of complex proteins. These capabilities extend to monoclonal antibodies, bispecific and trispecific antibodies, and other recombinant proteins for research purposes.
Sheng emphasized that the large molecule plant in Zhubei is now fully operational, with a professional team ready to deliver high-yield processes and comprehensive project management. The goal is to efficiently assist clients in developing a wide range of challenging molecular targets.
Ignacio Asial, Founder and CEO of DotBio, remarked that Bora Biologics’ early clinical manufacturing center aligns perfectly with DotBio’s IND development phase. Additionally, Bora’s commercial-scale production and fill-and-finish facilities in the United States are well-positioned to support DotBio’s mission of delivering therapies to patients worldwide.
Resource: 保瑞、新加坡DotBio合作 助力癌藥CMC製程開發
