OrganaBio has entered a manufacturing partnership with RxMP Therapeutics to support the development of investigational haemostatic therapy RMP-402 through technology transfer, qualification and current good manufacturing practice production.

Under the agreement, OrganaBio will act as RxMP’s contract manufacturing partner for RMP-402, providing manufacturing support as the candidate progresses through key development milestones. The collaboration combines OrganaBio’s manufacturing, quality assurance and analytical development capabilities with RxMP’s haemostatic technology platform.

RMP-402 is a late preclinical therapeutic composed of manufactured allogeneic red cell membrane particles designed to rapidly control severe bleeding following intravenous administration. The company is developing the candidate for use in civilian and military settings, where uncontrolled haemorrhage remains a major cause of preventable death.

The manufacturing agreement follows progress made by RxMP in 2025, when the company reached consensus with FDA on its proposed GMP manufacturing process for RMP-402 and entered into a Cooperative Research and Development Agreement with the US Department of Defense’s Institute of Surgical Research to further evaluate the therapy for combat casualties.

Justin Irizarry, chief executive officer of OrganaBio, said: “We are honored that RxMP has entrusted us with the manufacturing of RMP-402. This is a product that has the potential to fundamentally change how clinicians manage life-threatening bleeding events, and we take that responsibility seriously.”

He added that the company’s team was “energized by the opportunity to apply our cGMP manufacturing capabilities and quality-first approach to help bring this therapy closer to the patients who need it most”.

The partnership is intended to support technology transfer and GMP manufacturing activities while RxMP advances its regulatory strategy and completes remaining IND-enabling studies.

Shawna Khouri, chief operating officer of RxMP Therapeutics, said: “Selecting the right manufacturing partner is one of the most consequential decisions a company at our stage can make, and we are confident that OrganaBio’s combination of blood-products expertise and cGMP manufacturing under one quality system makes them the right partner for RxMP.”

She added: “With OrganaBio now established as our manufacturing partner, our team can sharpen its focus on advancing our regulatory strategy, completing the remaining IND-enabling studies, and deepening our collaboration with the Department of Defense, all while having full confidence that the manufacturing of RMP-402 is in capable and committed hands.”

The collaboration reflects continued investment in manufacturing capabilities aimed at supporting advanced therapeutic development for severe haemorrhage. OrganaBio said it will leverage its integrated manufacturing infrastructure and quality management systems to produce RMP-402, while RxMP continues development of the candidate with support from federal collaborators and private investors.