#USA #Philadelphia #Wuxi #Cell Therapy #Minaris

Introduction to Minaris Advanced Therapies

Minaris Advanced Therapies is positioned as a leading global Contract Development and Manufacturing Organization (CDMO), specializing in the development, production, and testing of cell and gene therapies. Formed through the strategic acquisitions orchestrated by Altaris Capital Partners, this new entity brings together Minaris Regenerative Medicine and WuXi Advanced Therapies’ operations in the U.S. and U.K. The formal introduction of Minaris Advanced Therapies occurred at the annual International Society for Cell & Gene Therapy (ISCT) conference held in New Orleans.

A Unifying Force

With its headquarters in Philadelphia, Pennsylvania, Minaris Advanced Therapies merges the expertise of two established firms, enhancing its capabilities in providing comprehensive cell therapy solutions. The company boasts state-of-the-art facilities across three continents, including manufacturing sites in Allendale, New Jersey; Philadelphia; Munich, Germany; and Yokohama, Japan. This global presence enables the organization to produce clinical and commercial products efficiently across a vast geographic footprint.

Track Record of Success

Minaris is distinguished by an impressive track record, having completed over 7,500 Good Manufacturing Practice (GMP)-compliant batches. Currently, the company manufactures two commercial cell therapies and conducts analytical services for more than 27 products. Their extensive expertise encompasses innovative platforms, comprehensive development, production capabilities for cell therapies and viral vectors, as well as thorough analytical services that facilitate product development, safety testing, and characterization.

Addressing Key Challenges

Iain Baird, Chairman of Minaris Advanced Therapies, noted that many CDMOs have struggled to transition from manual production to achieving cost-effective large-scale manufacturing. The mission of Minaris is to resolve these manufacturing and development challenges, thus facilitating the successful global commercialization of these promising therapies.

A Skilled Team

The company comprises a diverse pool of over 1,400 industry professionals skilled in scientific and regulatory knowledge. The analytical division brings unmatched expertise in developing analytical methods and performing GMP-compliant safety and characterization tests for internal and external programs. This robust team is well-equipped to expedite the processes necessary for making advanced therapies more accessible to patients.

Infrastructure and Capabilities

Minaris Advanced Therapies features significant infrastructure, with six facilities spanning over 68,000 square feet globally. This includes 42 modern commercial cleanrooms located in key markets, ensuring top-tier production quality. The firm's successful history includes more than 20 inspections by global health authorities such as the FDA, EMA, and TGA, reflecting its commitment to compliance and high standards. Additionally, Minaris holds over 22 patents related to its research services, including critical intellectual property for scalable AAV and lentiviral vector production.

Commitment to Innovation

Dr. Eytan Abraham, Chief Commercial and Technology Officer, emphasizes that Minaris Advanced Therapies is driven by the aim of increasing patient access to therapies by offering expert guidance, a global presence, and innovative platforms that streamline operations and enhance commercialization efforts. Existing technologies that are crucial for reducing costs and improving turnaround times are already in place, and Minaris is dedicated to accelerating their adoption and large-scale implementation.

Conclusion

Minaris Advanced Therapies represents a transformative force in the field of cell therapy, combining decades of experience, scientific expertise, and operational excellence. This strategic merger not only signifies a leap forward for the company but also positions it as an integral partner in advancing impactful therapies for patients worldwide. By focusing on speed, scalability, and scientific rigor, Minaris Advanced Therapies is set to lead the cell and gene therapy market into the future. For more information about this innovative CDMO, visit minaris.com.