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Minaris Advanced Therapies: Pioneering the Future of Cell Therapy

Minaris Advanced Therapies has made a remarkable entrance into the landscape of cell therapy as a leading global partner dedicated to the development, manufacturing, and testing of cell therapies. The company was officially unveiled at the ISCT Annual Conference in New Orleans and is the result of a strategic merger orchestrated by the investment firm Altaris, based in New York. This consolidation integrates Minaris Regenerative Medicine with WuXi Advanced Therapies, enhancing the capacity to tackle the evolving needs of the biopharmaceutical industry.

Minaris Advanced Therapies is headquartered in Philadelphia, Pennsylvania, and boasts state-of-the-art facilities for commercial production across three continents, including locations in Allendale, New Jersey, Munich, Germany, and Yokohama, Japan. The company specializes in the manufacture of clinical and commercial products, having demonstrated an impressive track record with over 7,500 GMP (Good Manufacturing Practice) batches produced.

Presently, Minaris Advanced Therapies is engaged in the production of two commercial cell therapies while offering testing services for more than 27 products. Their comprehensive capabilities span novel platforms, development and manufacturing of cell therapies and viral vectors, as well as extensive testing services. With over 25 years of experience in cell therapy CDMO and more than 40 years in biosecurity testing and product characterization, Minaris is well-positioned to support the upsurge of commercial cell therapies.

Addressing the Challenges of Cell Therapy Development

As Iain Baird, President of Minaris Advanced Therapies, aptly states, “CDMOs that support the cell therapy industry have struggled to evolve from a small-scale cottage industry into one that can offer cost-effective, large-scale manufacturing.” The core mission of Minaris Advanced Therapies is to overcome the developmental and manufacturing challenges that hinder successful commercialization of these promising therapies on a global scale.

The company’s team comprises over 1,400 industry professionals possessing deep scientific and regulatory knowledge, ensuring high standards in both development and manufacturing processes. Its testing unit combines unparalleled expertise in analytical method development with biosecurity testing and GMP-grade product characterization services. This dual focus allows Minaris to meet the escalating demand for therapies while adhering to stringent regulatory requirements.

Eytan Abraham, Ph.D., the Chief Commercial and Technology Officer, highlighted how Minaris Advanced Therapies is tailored to facilitate the industry in better serving patients: “We provide the experience, global footprint, and platforms necessary to accelerate timelines and enable commercialization.” He further emphasized that the essential technologies required to reduce product costs and improve response times are already in existence, and Minaris aims to drive the adoption and implementation of these solutions at scale.

A Legacy of Success

Minaris Advanced Therapies is strategically constructed for speed, scale, and scientific excellence. The company amalgamates:

• - A robust workforce of over 1,400 employees, experts in analytical and process development, manufacturing, quality control, quality assurance, and regulatory compliance.
• - Facilities spanning six sites across three continents, totaling over 730,000 square feet of infrastructure dedicated to cell therapy development.
• - 42 cutting-edge commercial cleanrooms located in Philadelphia, Allendale, Munich, and Yokohama that adhere to the highest industry standards.
• - A prolific history of more than 7,500 released GMP batches, indicating reliable capabilities in both manufacturing and testing.
• - Successful results from over 20 inspections by global health agencies, including the FDA, EMA, TGA, PMDA, MFDS, and USDA.
• - Extensive expertise in biosecurity testing and product characterization, with 1,700 tests developed annually and 10,000 samples received.
• - A portfolio featuring 22 patents in discovery services, including key intellectual property for scalable AAV TESSA® platform and lentiviral vector production capabilities with XOFLX™.

In conclusion, Minaris Advanced Therapies stands as a beacon of innovation in the cell therapy sector, ready to transform the therapeutic landscape through its commitment to quality and patient accessibility. For those interested in learning more about the pivotal role Minaris plays in the future of healthcare, visit minaris.com for further details.