Bora Biologics Secures Contract for RAPClot Protein Supply
News related to:Bora Biologics · 2 min read
Bora Biologics, a U.S.-based biologics contract development and manufacturing organization (CDMO), has secured a significant contract to supply recombinant RAPClot™ protein for the commercialization of Q Sera Pty Ltd's patented technology. This development marks a crucial step in the launch of VenoJect® II RAPClot blood collection tubes in Japan by Terumo Corporation, a global medical device leader.
Bora Biologics was chosen for this project due to its advanced cell line capabilities, expertise in recombinant protein manufacturing, and ability to meet Q Sera's stringent yield and production requirements. The company successfully scaled up the production process to meet commercial demands, leading to a long-term supply agreement that supports Q Sera's commercialization pathway.
The RAPClot™ technology, developed by Q Sera, utilizes recombinant ecarin, a prothrombin activator, to accelerate clot formation and generate high-quality serum for biochemical analysis. This innovation promises to reduce turnaround times and enhance laboratory efficiency, making it a significant advancement in blood collection tube technology.
Stephen Lam, CEO of Bora Biologics, expressed the company's validation through this collaboration.
Jennifer Kuan, Vice President of Taiwan Operations at Bora Biologics, highlighted the company's expertise in handling complex recombinant proteins.
Bora Biologics, with its presence in Zhubei City, Taiwan; Rockville, Maryland; and San Diego, California, offers integrated services from early-stage development through process performance qualification (PPQ) and long-term commercial manufacturing. The company has executed over 200 successful cGMP batches, including more than 60 commercial batches within its U.S. network. This robust track record positions Bora Biologics as a reliable partner for clients bringing specialized biologic and recombinant protein products into regulated global markets.
The agreement with Q Sera and Terumo Corporation extends Bora Biologics' commercial supply portfolio into advanced diagnostic applications. It demonstrates the company's capability to support complex recombinant protein products from development and scale-up through long-term commercial supply. This partnership is a testament to Bora Biologics' commitment to innovation and quality in the biologics manufacturing industry.
The successful launch of VenoJect® II RAPClot blood collection tubes in Japan represents a significant milestone in the commercialization of Q Sera's patented technology. This launch underscores the readiness of RAPClot technology for widespread adoption and highlights the importance of robust manufacturing capabilities in bringing cutting-edge medical innovations to market.