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AGC Biologics and Repair Biotechnologies Partner on Novel mRNA Therapeutic to Combat the Leading Cause of Human Mortality

via Business Wire

Partnership leverages AGC Biologics’ cost-effective and dependable cGMP mRNA and LNP capabilities

AGC Biologics today announced it is partnering with Repair Biotechnologies to tackle one of the world's most persistent health challenges and cause of mortality. The collaboration will focus on developing and manufacturing a novel mRNA therapy to rapidly stabilize and reduce the size of atherosclerotic plaques in major blood vessels. Rupture of unstable plaque and subsequent heart attack or stroke is the leading cause of death, accounting for 27% of all human mortality.

“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.”

For pioneering companies like Repair Biotechnologies, navigating the complex manufacturing landscape is a critical challenge. By consolidating the entire production journey, AGC Biologics provides a streamlined and de-risked path to the clinic and market without expensive services or complex technologies.

This collaboration will leverage AGC Biologics' comprehensive mRNA manufacturing knowledge and expertise that allows innovators to manage the entire process from the initial plasmid DNA blueprint to the final drug product encapsulated in lipid nanoparticles with a single, experienced partner.

“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.”

This partnership is a noteworthy addition to the present evolution of mRNA technology, moving beyond infectious diseases and into the realm of treating chronic, age-related conditions. In 2021 the AGC Biologics Heidelberg facility provided plasmid DNA starting material for the Pfizer-BioNTech COVID-19 vaccine. Building on mRNA advances from the pandemic, Repair Biotechnologies is developing a new therapy that breaks down toxic excess free cholesterol inside cells. This process aims to reverse previously irreversible cardiovascular conditions by removing a key detriment to aging, obesity, and cardiovascular caused death.

The plasmid DNA and messenger RNA production line at the AGC Biologics Heidelberg site uses state-of-the-art single-use equipment, creating flexibility, shorter timelines and faster project turnover. The site’s GMP practices are compliant with European Medicines Agency and U.S. Food and Drug Administration standards.

To learn more about AGC Biologics’ end-to-end mRNA services, visit www.agcbio.com/capabilities/mrna.

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 Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

“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."

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