Monday, 14 September 2026 07:45 AM
Partnerships
Successful scale-up to commercial production supports long-term supply agreement for Q Sera's patented RAPClot technology
SAN DIEGO, CA / ACCESS Newswire / September 14, 2026 / Bora Biologics, a U.S.-anchored biologics contract development and manufacturing organization (CDMO) built for licensed supply, today announced that it has entered into a long-term supply agreement to provide recombinant RAPClot™ protein for Q Sera Pty Ltd. The agreement supports Q Sera's commercialization pathway with Terumo Corporation for the Japan launch of VenoJect® II RAPClot blood collection tubes, marking the first commercial introduction of Q Sera's patented RAPClot technology.
Bora Biologics was initially selected to support the development and scale-up of RAPClot based on its proprietary cell line capabilities, recombinant protein manufacturing expertise, and ability to meet Q Sera's yield and production requirements. Successful scale-up to commercial production led to the current long-term supply agreement supporting Q Sera's commercialization pathway with Terumo.
Terumo's Japan launch represents a significant advancement in blood collection tube innovation and underscores the commercial readiness of RAPClot technology. Bora Biologics' role reflects its ability to develop and scale complex recombinant proteins using industry-standard biopharmaceutical processes under rigorous quality controls.
RAPClot technology utilizes recombinant ecarin, a prothrombin activator, to accelerate clot formation and rapidly generate high-quality serum for biochemical analysis - including from anticoagulated blood - reducing turnaround time and improving laboratory efficiency.
"Supporting a commercial launch with a global medical device leader such as Terumo is a meaningful validation of our recombinant protein development and scale-up platform," said Stephen Lam, CEO, Bora Biologics. "This collaboration reinforces our ability to deliver specialized recombinant proteins at commercial scale through disciplined process development, scale-up execution, and quality-focused supply."
"Recombinant ecarin production requires precise process control, reproducibility, and strong yield performance at commercial scale," said Jennifer Kuan, Vice President, Taiwan Operations, Bora Biologics. "This partnership reflects the depth of our recombinant protein expertise and the operational rigor required to support specialized proteins entering regulated global markets."
Bora Biologics provides integrated process and analytical method development and biologics manufacturing across facilities in Taiwan and the United States, supporting therapeutic biologics and specialty recombinant proteins for global markets. Across its platform, the company has executed more than 200 successful cGMP batches, including over 60 commercial batches within its U.S. network.
The agreement underscores Bora Biologics' ability to support partners bringing specialized biologic and recombinant protein products into regulated global markets, including Japan. It also extends the company's commercial supply portfolio into advanced diagnostic applications and demonstrates Bora Biologics' capability to support complex recombinant protein products from development and scale-up through long-term commercial supply.
RAPClot™ is a trademark of Q Sera Pty Ltd.
VenoJect® is a registered trademark of Terumo Corporation.
About Bora Biologics
Bora Biologics is a U.S.-anchored biologics contract development and manufacturing organization (CDMO) built for licensed supply. The company provides integrated services from early-stage development through process performance qualification (PPQ) and long-term commercial manufacturing.
Spanning development through licensed commercial supply across Zhubei City, Taiwan; Rockville, Maryland; and San Diego, California, Bora Biologics offers a unified lifecycle platform engineered to reduce tech transfer risk and strengthen launch readiness under a single integrated quality system.
Across its platform, Bora Biologics has executed more than 200 successful cGMP manufacturing batches, including over 60 commercial batches, supporting 4 active commercial programs supplying 6 global markets. The company has supported the development of more than 48 biologics and biosimilars across monoclonal antibodies, bispecific antibodies, and related biologic modalities.
Through its strategic relationship with Bora Pharmaceuticals, clients also have access to scalable fill/finish capabilities, including stability testing and final packaging for clinical and commercial products.
Bora Biologics is a DBA of Tanvex BioPharma USA, Inc.
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SOURCE: Bora Biologics