Partnership targets innovative mRNA therapy to reduce dangerous atherosclerotic plaque.
AGC Biologics has announced a new partnership with Repair Biotechnologies aimed at advancing an innovative mRNA therapeutic designed to combat one of the most stubborn and deadly health threats worldwide: atherosclerotic cardiovascular disease. The collaboration pairs AGC Biologics’ established, cost-efficient cGMP mRNA and lipid nanoparticle (LNP) manufacturing expertise with Repair Biotechnologies’ scientific mission to reverse the processes that drive plaque formation and instability in major blood vessels. Together, the companies aim to deliver a therapy capable of stabilizing—and ultimately reducing—the dangerous plaques that lead to heart attacks and strokes, which remain the leading cause of death globally and account for roughly 27% of all human mortality.
Atherosclerosis, the gradual buildup of plaque within arterial walls, is often a silent condition until a catastrophic event such as plaque rupture occurs. When an unstable plaque breaks open, the resulting blockage can cause a heart attack, stroke, or other life-threatening complications. Repair Biotechnologies is developing a novel mRNA-based approach designed to rapidly stabilize these plaques and shrink their size by targeting excess free cholesterol within cells. The company’s technology aims to break down this toxic cholesterol burden, addressing one of the root biochemical drivers of cardiovascular disease and associated age-related decline. By intervening at this fundamental level, the therapy holds the potential not only to treat the condition but to reverse processes long considered irreversible.
According to Reason, the CEO and co-founder of Repair Biotechnologies, the journey to develop such a therapy requires exceptionally strong, reliable, and flexible manufacturing support. “Developing a novel mRNA therapeutic as part of the vital goal of curing atherosclerotic cardiovascular disease is a complex task, and robust manufacturing is critical to our progress,” he said. He noted that the company chose AGC Biologics because of its demonstrated mastery of the full mRNA production chain—expertise that minimizes risks, eliminates delays, and delivers the reliable GMP-grade drug product needed for swift clinical trial progression. “We are pleased to work with AGC Biologics to advance our mission to help people enjoy longer, healthier lives,” Reason added.
The manufacturing landscape for emerging biotechnologies—particularly those involving mRNA and advanced nucleic acid platforms—is highly complex. A development misstep at any stage can introduce major delays or introduce regulatory risks that jeopardize a program’s future. For small, pioneering companies like Repair Biotechnologies, navigating this environment is often one of the greatest operational challenges. AGC Biologics’ model addresses this by consolidating the full manufacturing workflow under one roof, creating a simplified, de-risked pathway from early development through commercial readiness. Rather than juggling multiple vendors or integrating incompatible technologies, developers benefit from a single, experienced partner capable of managing the plasmid DNA blueprint, mRNA production, purification, and LNP formulation all within a unified system.
AGC Biologics’ Heidelberg facility, where the partnership’s manufacturing work will be conducted, is specifically equipped to support advanced nucleic acid therapeutics. The site utilizes state-of-the-art single-use equipment that enhances operational flexibility, shortens project timelines, and enables faster transitions between production campaigns. These capabilities make it possible to adjust rapidly as a therapy evolves through clinical testing, scaling production in alignment with milestones or changing regulatory needs. The facility also operates under strict GMP standards aligned with both the European Medicines Agency and the U.S. Food and Drug Administration, ensuring global regulatory compliance.
“Our approach is built on being a cost-effective, reliable cGMP provider for life-saving mRNA treatments,” said Alberto Santagostino, CEO of AGC Biologics. “For clients like Repair Biotechnologies, we can take therapies from preclinical stages all the way to commercial production. As the friendly CDMO partner, our no-frills, expert approach is economical while never compromising manufacturing excellence or quality.” He emphasized that AGC’s streamlined system allows developers to focus on scientific innovation while trusting that production needs will be handled efficiently and with the highest standards.
The partnership also reflects a significant shift in the evolution of mRNA technology. Over the past decade, and especially since the global COVID-19 pandemic, mRNA has rapidly evolved from a highly specialized research tool into a mainstream therapeutic platform. While the public largely associates mRNA technologies with vaccines, the field is now expanding into chronic, age-related, and non-infectious conditions. Repair Biotechnologies’ work represents this next frontier—using mRNA not to encode viral antigens but to trigger beneficial cellular processes that could correct disease-driving imbalances within the body.
AGC Biologics has played a prominent role in this evolution. In 2021, its Heidelberg facility produced plasmid DNA starting material for the Pfizer-BioNTech COVID-19 vaccine—work that supported one of the most rapid vaccine development and deployment efforts in history. With these foundations in place, the company has expanded its nucleic acid manufacturing operations to support not only pandemic-related products but also next-generation therapies emerging from the biotechnology sector.
Repair Biotechnologies’ therapeutic approach is shaped by the growing recognition that cardiovascular disease is not simply a matter of blocked arteries; it is deeply intertwined with cellular aging processes. Excess free cholesterol accumulation inside cells triggers inflammation, impairs normal function, and contributes to the gradual deterioration of vascular health. By using mRNA to reverse this buildup, the company aims to unlock a new class of therapies capable of addressing cardiovascular disease at its root rather than managing symptoms or slowing progression. If successful, this strategy could help reverse disease states that were previously considered unchangeable—particularly in individuals with long-standing atherosclerosis, obesity-related cardiovascular dysfunction, or age-associated metabolic decline.
AGC Biologics’ integrated manufacturing pipeline is designed to complement this innovative therapeutic model. The company’s end-to-end platform covers plasmid DNA production, mRNA synthesis, purification, analytical testing, and LNP encapsulation. Housing these steps within a single partner eliminates traditional handoffs that often slow down development, increase costs, or introduce variability. For rapidly evolving therapeutic platforms like mRNA, maintaining consistency and reliability across the entire production chain is essential, particularly when transitioning from preclinical research to first-in-human trials.
By combining AGC Biologics’ manufacturing infrastructure with Repair Biotechnologies’ scientific ambition, the partnership aims to accelerate the development of a therapy that could fundamentally reshape how cardiovascular disease is treated. The collaboration represents a convergence of expertise—engineering, bioprocessing, and cellular biology—directed toward a condition that continues to impose heavy global health and economic burdens.
As both companies move forward, their shared goal is clear: to bring a transformative therapy to the clinic as efficiently and safely as possible. If the partnership succeeds, it may signal a new era in which mRNA is used not only to prevent infectious diseases but also to repair the underlying mechanisms of chronic conditions that have resisted effective treatment for decades.
About Repair Biotechnologies
Repair Biotechnologies develops first-in-class therapies that break down the undruggable target of toxic free cholesterol inside cells to rapidly reduce arterial plaque in atherosclerosis and familial hypercholesterolemia, reverse liver fibrosis in metabolic disorders, and which have the potential to treat numerous other conditions associated with aging and obesity.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. AGC Biologics is a part of AGC Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals.
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