#USA #Philadelphia #Cell Therapy #Minaris Advanced #WuXi Advanced

Minaris Advanced Therapies: A New Dawn in Cell Therapy Development

In a landmark announcement made during the annual ISCT conference in New Orleans, Minaris Advanced Therapies has emerged as a leading global contract development and manufacturing organization (CDMO) dedicated to cell therapy. This newly formed entity is a result of strategic acquisitions by Altaris, a New York-based investment firm, and merges the innovative strengths of Minaris Regenerative Medicine with the U.S. and U.K. operations of WuXi Advanced Therapies.

A Global Footprint for Cell Therapy

Headquartered in Philadelphia, Pennsylvania, Minaris Advanced Therapies boasts modern production facilities positioned in key regions across the globe, including Allendale, NJ, Munich in Europe, and Yokohama, Japan. With these facilities certified for commercial production, Minaris is set to manufacture clinical and commercial products in three continents. The company has a remarkable track record, having successfully delivered over 7,500 Good Manufacturing Practice (GMP) batches to date.

Currently, Minaris produces two commercial cell therapies and provides extensive testing services for more than 27 commercial products. Noteworthy capabilities include innovative platforms and extensive development and manufacturing solutions for cell therapies and viral vectors. Moreover, with over 25 years of experience in cell therapy CDMO and more than four decades in biosafety testing, the company is well-equipped to support the upcoming wave of commercial cell therapies.

Overcoming Industry Challenges

The chairman of Minaris Advanced Therapies, Iain Baird, acknowledged the struggles faced by CDMOs in the cell therapy industry, specifically their evolution from small-scale operations to delivering cost-effective manufacturing solutions at scale. "Our mission is to solve the development and manufacturing challenges that hinder the successful worldwide commercialization of these promising therapies," Baird stated, highlighting the company's commitment to innovation.

The team at Minaris consists of over 1,400 industry professionals who bring a wealth of scientific knowledge and regulatory expertise to the table. This experienced staff is pivotal in providing unrivaled analytical method development, GMP-grade biosafety, and product characterization testing services.

Eytan Abraham, Ph.D., the company's chief commercial and technology officer, emphasized Minaris' aim to treat more patients across the globe. He stated, "Minaris Advanced Therapies is designed to help the industry by providing the experience, global footprint, and platforms necessary to accelerate timelines and facilitate commercialization." With existing technologies ready to reduce production costs and improve turnaround times, the company aims to scale their implementation effectively.

Built on Innovation

Minaris Advanced Therapies is structured for agility in manufacturing and scientific development. Key attributes contributing to their success include:

• - A solid team: Incorporating over 1,400 staff members focused on process and analytical development, quality control, and regulatory compliance.
• - Infrastructure: Spanning six sites across three continents, the organization features over 730,000 square feet of operational space.
• - Cleanroom facilities: Equipped with 42 state-of-the-art clean rooms in Philadelphia, Allendale, NJ, Munich, and Yokohama for commercial use.
• - Impressive track record: More than 7,500 GMP batches released, currently manufacturing two commercial products, and testing over 27 others.
• - Regulatory excellence: Possessing a history of successful inspections conducted by global health authorities, including the FDA and EMA.

Minaris also holds over 22 patents related to key discovery services, enhancing their position in the market by leveraging exclusive intellectual property for scalable AAV and novel packaging systems for lentiviral vector production.

About Minaris Advanced Therapies

Minaris Advanced Therapies focuses exclusively on cell and gene therapies, providing essential support for therapy developers through the stages of early development, clinical trials, and commercial manufacturing. By intertwining their scientific expertise with top-tier manufacturing and testing services, Minaris aims to bring safe and effective therapies to patients more quickly and efficiently than ever before. For additional information, visit minaris.com.