SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics has signed a strategic development and manufacturing agreement with Repair Biotechnologies to advance a novel mRNA therapeutic aimed at rapidly stabilizing and shrinking atherosclerotic plaques, addressing what both partners describe as the leading single cause of human mortality worldwide.
Targeting plaque biology in a high-burden cardiovascular market
The collaboration focuses on an mRNA-based therapy designed to stabilize and reduce atherosclerotic plaques in major blood vessels, directly tackling the root pathology behind heart attacks and strokes. Rupture of unstable plaque and subsequent thrombotic events account for an estimated 27% of all human deaths, underscoring the strategic importance of any technology capable of reversing or halting plaque progression.
Repair Biotechnologies is developing an mRNA construct that breaks down toxic excess free cholesterol inside cells, with the goal of reversing previously irreversible cardiovascular conditions. Beyond atherosclerosis, the company is targeting familial hypercholesterolemia, liver fibrosis in metabolic disorders and a wider set of age- and obesity-related conditions in which intracellular cholesterol accumulation drives disease.
End-to-end mRNA and LNP manufacturing in Heidelberg
AGC Biologics will provide integrated cGMP services from plasmid DNA through to lipid nanoparticle (LNP)-encapsulated mRNA drug product, consolidating the full production chain under one partner. The Heidelberg facility-already known for supplying plasmid DNA starting material for the Pfizer-BioNTech COVID-19 vaccine-uses state-of-the-art single-use equipment to offer flexible capacity, shorter timelines and faster project turnover.
The manufacturing scope spans:
- Plasmid DNA design and production as the blueprint for mRNA synthesis
- cGMP mRNA production and purification ready for formulation
- LNP encapsulation of mRNA into final drug product for clinical use
The site operates under GMP standards compliant with both the European Medicines Agency and the U.S. Food and Drug Administration, providing a regulatory framework suitable for global clinical development and potential commercialization.
De-risking the path from preclinical to commercial
For an emerging biotech focused on a high-risk, high-impact indication, securing reliable manufacturing is central to development strategy. "Developing a novel mRNA therapeutic as a part of the vital goal of curing atherosclerotic cardiovascular disease is a complex task, and robust manufacturing is critical to our progress," said Reason, CEO and co-founder, Repair Biotechnologies. "We chose AGC Biologics because they have mastered the entire production chain for therapeutics of this class, eliminating critical risks and delays to provide a fast and reliable path to the GMP drug product needed for our clinical trials. We are pleased to work with AGC Biologics to advance our mission to help people enjoy longer, healthier lives."
By consolidating production within a single CDMO, Repair Biotechnologies aims to reduce handoff risk, avoid fragmented vendor relationships and maintain tighter control over quality and timelines as the program transitions into clinical studies.
mRNA platforms expand beyond infectious disease
The partnership illustrates how mRNA technology is moving from pandemic-driven vaccine use into chronic, age-related diseases with large, unmet needs. With platform knowledge from COVID-19 programs and established infrastructure for mRNA and LNPs, CDMOs like AGC Biologics are positioned to accelerate next-generation applications in cardiovascular and metabolic medicine.
"For clients like Repair Biotechnologies, we can be the most cost-effective, reliable, cGMP provider that can take life-saving mRNA treatments through the journey from preclinical to commercial stages," said Alberto Santagostino, CEO, AGC Biologics. "As the friendly CDMO expert, this is emblematic of our no-frills, expert approach is economical while never compromising good manufacturing and quality. Our approach ensures developers can radically transform quality of life around the world without breaking the bank."
For payers and health systems, the prospect of a disease-modifying mRNA therapy that directly reduces plaque burden could shift long-term cardiovascular risk management, complementing existing lipid-lowering and antithrombotic regimens with a mechanistically distinct intervention.
Strategic positioning in the mRNA CDMO landscape
This agreement reinforces AGC Biologics' broader positioning as a global CDMO for advanced modalities, covering therapeutic proteins, plasmid DNA, mRNA, viral vectors and engineered cells across facilities in the U.S., Europe and Asia. For Repair Biotechnologies, the collaboration is a critical enabler in turning a first-in-class biology concept into a viable therapeutic candidate ready for clinical testing.
As the program progresses, the alliance will be watched as a benchmark for how cost-effective, integrated manufacturing can support mRNA's expansion into high-burden, chronic indications such as atherosclerotic cardiovascular disease, where the clinical and economic stakes are exceptionally high.
For more details on AGC Biologics' end-to-end mRNA capabilities, visit https://www.agcbio.com/capabilities/mrna.