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Minaris Advanced Therapies: A New Era in Cell Therapy

Minaris Advanced Therapies has recently emerged as a key player in the field of cell therapy, establishing itself as a global leader dedicated to the development, manufacturing, and testing of innovative cell therapies. This transformation was made possible through strategic acquisitions orchestrated by Altaris, a New York-based investment firm. By combining Minaris Regenerative Medicine with WuXi Advanced Therapies' U.S. and U.K. operations, the company has positioned itself to lead the industry in new and exciting ways.

Headquartered in Philadelphia, Pennsylvania, Minaris Advanced Therapies boasts modern facilities approved for commercial production across the United States, Europe, and Asia-Pacific. These include state-of-the-art sites in Allendale, New Jersey, Philadelphia, Munich, and Yokohama, Japan. With a track record of delivering over 7,500 compliant batches, Minaris not only facilitates robust clinical-stage production but also supports a number of commercial products.

One of the significant advantages that Minaris Advanced Therapies offers is its extensive capability set, including innovative platforms and comprehensive development and manufacturing services for cell therapies and viral vectors. As a result, the company is uniquely equipped to support the next wave of commercial cell therapies that hold promise for patients worldwide.

Iain Baird, the president of Minaris Advanced Therapies, highlighted the challenges faced by Contract Development and Manufacturing Organizations (CDMOs) in transitioning from small-scale artisanal production to cost-effective large-scale manufacturing. He stated, “Our mission is to address the development and manufacturing challenges that hinder these promising therapies from being successfully commercialized globally.” This ambition underscores Minaris's commitment to enabling the global market access of effective cell therapies.

The Minaris team comprises more than 1,400 industry professionals who bring together significant scientific and regulatory expertise. The company’s testing unit is renowned for its excellence in developing analytical methods and providing biosafety testing services that meet Good Manufacturing Practice (GMP) quality standards for both internal and external programs. Eytan Abraham, Ph.D., the Chief Commercial and Technology Officer, articulated Minaris's goal of treating more patients by streamlining the commercialization process through its vast experience and global footprint.

Minaris Advanced Therapies has designed its operations for speed, scale, and scientific precision. The company integrates over 1,400 employees specializing in various domains such as process development, manufacturing, quality control, and regulatory compliance. Their facilities encompass more than 730,000 square feet of infrastructure and include 42 cutting-edge commercial clean rooms located in multiple countries.

Achieving over 7,500 GMP-compliant batches and currently producing two commercial cell therapy products while conducting tests for over 27 others illustrates the company's proven capabilities. Furthermore, Minaris has successfully passed numerous inspections from international health authorities, including the FDA, EMA, TGA, PMDA, MFDS, and USDA. With over four decades of experience in biosafety testing and product characterization, the organization aims to remain at the forefront of the industry’s evolution.

Minaris is also the holder of 22 patents relating to its discovery services, including crucial intellectual property rights for the scalable TESSA® AAV platform and the XOFLX™ cell lines used for lentiviral vector production.

In conclusion, Minaris Advanced Therapies is well-positioned to usher in a new era for cell therapy through its focused expertise, state-of-the-art manufacturing capabilities, and commitment to quality and compliance. The company aims to bridge the existing gaps in the cell therapy market, making groundbreaking treatments available to a broader patient population, and ultimately contributing to the advancement of global healthcare.

For those interested in learning more about Minaris Advanced Therapies, visit minaris.com.