OrganaBio and RxMP Therapeutics Forge Manufacturing Alliance to Advance Development of RMP-402 Hemostatic Therapy
OrganaBio and RxMP Therapeutics have announced a strategic manufacturing partnership aimed at advancing the development of a novel therapy designed to rapidly control severe bleeding. Under the agreement, OrganaBio will serve as the contract manufacturing partner responsible for current Good Manufacturing Practice (cGMP) production of RxMP’s lead investigational product, RMP-402.
This collaboration brings together OrganaBio’s vertically integrated capabilities in blood and cell product manufacturing with RxMP’s innovative hemostatic technology platform. The partnership is intended to accelerate the progression of RMP-402 through critical development stages, including technology transfer, process qualification, and clinical-grade manufacturing, ultimately supporting the therapy’s advancement toward regulatory submission and clinical evaluation.
Building a foundation for scalable manufacturing
As part of the agreement, OrganaBio will oversee the transfer of RxMP’s manufacturing process into its own facilities, followed by process optimization and validation under cGMP standards. These steps are essential to ensure that RMP-402 can be produced consistently, safely, and at the quality required for clinical use. OrganaBio will also apply its established quality management systems and analytical development expertise to support the product’s progression through key regulatory milestones.
The company’s infrastructure is specifically designed to support complex biologics and cell-based therapies, making it well positioned to handle the unique manufacturing requirements associated with RMP-402. By integrating manufacturing, quality assurance, and analytical services within a single platform, OrganaBio aims to streamline development timelines while maintaining rigorous quality standards.
A first-in-class approach to controlling severe hemorrhage
RMP-402 represents a novel therapeutic approach to managing life-threatening bleeding, a major global health challenge in both civilian and military settings. The product is composed of manufactured allogeneic red cell membrane particles (RMPs), which are engineered to mimic naturally occurring particles found in human blood. These particles are designed to promote rapid clot formation at the site of injury when administered intravenously.
Unlike traditional clotting agents, RMP-402 is intended to stop bleeding quickly without increasing the risk of unintended clot formation elsewhere in the body—a critical safety consideration in trauma care. This targeted mechanism could offer a significant advantage over existing treatments, particularly in emergency situations where rapid intervention is essential.
Uncontrolled bleeding remains one of the leading causes of preventable death worldwide, especially in cases of trauma, major surgery, and battlefield injuries. The global market for trauma and surgical bleeding interventions is estimated to be approximately $12 billion annually, underscoring both the scale of the clinical need and the potential impact of innovative therapies like RMP-402.
Advancing through regulatory and defense collaborations
RxMP has already made important progress in advancing RMP-402 toward clinical development. In 2025, the company reached agreement with the U.S. Food and Drug Administration on its proposed GMP manufacturing process, a key step in aligning with regulatory expectations for future clinical trials. This consensus provides a clear pathway for the product’s continued development under established regulatory guidelines.
In addition, RxMP has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research, part of the U.S. Department of Defense. This collaboration is focused on further validating the therapeutic potential of RMP-402 in treating severe hemorrhage, particularly in combat settings where rapid and effective bleeding control is critical for survival.
The involvement of defense research organizations highlights the potential dual-use applications of RMP-402, spanning both military and civilian healthcare environments. In battlefield scenarios, where access to immediate surgical care may be limited, a fast-acting intravenous therapy could significantly improve survival outcomes. Similarly, in civilian trauma care, such a treatment could enhance emergency response capabilities and reduce mortality associated with severe bleeding.
Leadership perspectives on the partnership
Justin Irizarry, Chief Executive Officer of OrganaBio, emphasized the company’s commitment to supporting innovative therapeutics through high-quality manufacturing services. He noted that OrganaBio was built to be a responsive and rigorous partner for emerging biotechnology companies, and expressed enthusiasm about contributing to the development of a therapy with the potential to transform the management of life-threatening bleeding events.
Irizarry highlighted that the company’s team is motivated by the opportunity to apply its cGMP manufacturing expertise and quality-focused approach to help bring RMP-402 closer to patients who urgently need new treatment options.
From RxMP’s perspective, the selection of a manufacturing partner is a critical decision that can significantly influence the success of a development program. Shawna Khouri, Chief Operating Officer of RxMP Therapeutics, underscored the importance of OrganaBio’s combined expertise in blood product science and cGMP manufacturing under a unified quality system. She expressed confidence that the partnership will enable RxMP to move forward with both speed and precision as it advances RMP-402 toward clinical readiness.
Khouri also noted that with manufacturing responsibilities now in capable hands, RxMP can focus more intensively on its regulatory strategy, completion of investigational new drug (IND)-enabling studies, and ongoing collaboration with defense partners. This alignment of responsibilities is expected to enhance efficiency and ensure that each organization can leverage its core strengths.
Addressing a critical unmet medical need
The urgency of developing effective treatments for severe hemorrhage cannot be overstated. Despite advances in trauma care, uncontrolled bleeding continues to account for a significant proportion of deaths that could potentially be prevented with timely intervention. Existing treatment options are often limited by logistical challenges, delayed onset of action, or safety concerns related to systemic clotting.
RMP-402’s novel mechanism and potential for rapid intravenous administration position it as a promising candidate to address these limitations. If successful, the therapy could become an important tool for emergency responders, surgeons, and military medical personnel, offering a new way to stabilize patients and improve outcomes in critical situations.
The partnership between OrganaBio and RxMP Therapeutics reflects a broader trend in the biopharmaceutical industry toward strategic collaborations that combine specialized expertise to accelerate innovation. By integrating advanced manufacturing capabilities with cutting-edge therapeutic development, the two companies aim to bring RMP-402 through the next stages of development and closer to clinical use.
OrganaBio continues to expand its manufacturing and service capabilities from its headquarters in Miami, reinforcing its position as a key partner for cell and gene therapy developers. Meanwhile, RxMP is advancing a robust development program for RMP-402, supported by both federal partnerships and private investment.
Together, the companies are working toward a shared goal: addressing one of the most pressing unmet needs in medicine by developing a first-in-class therapy capable of saving lives in situations where every second counts.
About OrganaBio
OrganaBio, LLC is a vertically integrated blood and cell products and services company headquartered in Miami, Florida. Through its wholly owned, FDA-registered subsidiaries, OrganaBio operates proprietary supply chains for ethically sourced human tissues and blood-derived cellular products, and delivers a comprehensive suite of cGMP manufacturing, analytical development, quality assurance, and regulatory support services.
By combining upstream sourcing with downstream manufacturing and development expertise under a single quality framework, OrganaBio enables cell and gene therapy developers to accelerate the translation of novel therapeutics from bench to bedside. For more information, visit www.organabio.com.
About RxMP Therapeutics
RxMP Therapeutics, Inc. is a therapeutics company in late stage pre-clinical development advancing novel therapies for the rapid control of severe hemorrhage. Its lead product candidate, RMP-402, is a first-in-class hemostatic therapeutic inspired by naturally occurring red blood cell membrane particles and is designed to rapidly stop bleeding without increasing the risk of off-target clotting.
RMP-402 is being developed for use in both civilian and military settings, addressing a global trauma and surgical bleeding market estimated at up to 12 billion dollars annually, where uncontrolled bleeding remains a leading cause of morbidity and preventable death.
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