#USA #Philadelphia #Minaris Advanced Therapies #WuXi Advanced Therapies #Altaris

Minaris Advanced Therapies: A New Era in Cell Therapy

Introduction

Minaris Advanced Therapies has officially launched, positioning itself as a prominent global partner focused on the development, manufacturing, and testing of cell therapies. This new entity was created through strategic acquisitions overseen by Altaris, a New York-based investment firm. At its core are Minaris Regenerative Medicine and the U.S. and U.K. branches of WuXi Advanced Therapies, which have now combined their expertise to provide comprehensive solutions in the cell therapy landscape.

Headquarters and Global Presence

Headquartered in Philadelphia, Pennsylvania, Minaris Advanced Therapies boasts state-of-the-art facilities across three continents. With commercial production sites in Allendale, NJ, Philadelphia, Munich, and Yokohama, Japan, the company is poised to manufacture clinical-stage and commercial products globally. Its capabilities cover an impressive range, with proven history in delivering over 7,500 Good Manufacturing Practice (GMP) batches.

Industry Challenges

As the cell therapy sector faces the challenge of scaling operations effectively, Iain Baird, chairman of Minaris Advanced Therapies, emphasizes the necessity for evolution within Contract Development and Manufacturing Organizations (CDMOs). Traditionally, these organizations have struggled to transition from small-scale operations to efficient and cost-effective manufacturing at scale. Therefore, Minaris Advanced Therapies aims to address these developmental hurdles to enable the successful commercialization of promising therapies worldwide.

Technological Expertise and Capacity

The newly formed entity integrates extensive experience with cutting-edge technology. With more than 1,400 skilled professionals specializing in diverse sectors of process and analytical development, quality assurance, and regulatory compliance, Minaris Advanced Therapies is equipped to tackle the complex demands of cell therapy development. Notably, the facility includes 42 modern cleanrooms dedicated to commercial use across its locations, further enhancing its operational capacity.

The organization’s repertoire encompasses the manufacturing of two commercial cell therapies along with testing services for upwards of 27 commercial products. Featuring innovative platforms, the company integrates advanced methodologies in cell therapies and viral vectors while also offering comprehensive testing services that adhere to the highest industry standards.

Regulatory Acumen

Minaris Advanced Therapies has garnered wide recognition for its regulatory knowledge and successful track record. The company has successfully navigated more than 20 inspections by leading global health authorities, including the FDA, EMA, TGA, and PMDA. Their dedication to quality is reflected in their capability to perform more than 1,700 assays annually and process over 10,000 samples each year.

Vision for Future Treatment

Eytan Abraham, Ph.D., the chief commercial and technology officer, expresses the ambition of Minaris Advanced Therapies to enhance patient treatment access. With a collaborative approach, the company seeks to accelerate timelines and facilitate commercialization in cell therapy avenues. Leveraging existing technologies, they aim not only to reduce production costs but also to enhance turnaround times, crucial for the rapid evolution of therapeutic applications.

Conclusion

As Minaris Advanced Therapies embarks on this pivotal journey, its commitment to empowering the cell therapy industry is unwavering. The combination of scientific expertise with advanced manufacturing and testing capabilities positions Minaris as a key player in transforming the landscape of cell and gene therapies. Through its ambitious initiatives, the company is dedicated to expediting the delivery of safe and effective therapies to a broader patient population worldwide.

For more information on their offerings or to learn about their latest advancements, please visit minaris.com.