Through strategic acquisitions made by New York–based investment firm Altaris, Minaris Regenerative Medicine and the U.S. and U.K. operations of WuXi Advanced Therapies have been combined to form Minaris Advanced Therapies™, a global cell therapy CDMO and testing partner. The company is headquartered in Philadelphia, Pennsylvania.

With modern facilities approved for commercial production in the United States (Allendale, NJ and Philadelphia), Europe (Munich) and Asia-Pacific (Yokohama, Japan), Minaris Advanced Therapies manufactures clinical-stage and commercial products on three continents and has a proven track record of delivering more than 7,500 GMP batches.

The company currently manufactures two commercial cell therapies and provides testing services for more than 27 commercial products. The company's capabilities include innovative platforms, development and manufacturing capabilities for cell therapies and viral vectors, and extensive testing services. With more than 25 years of cell therapy CDMO experience and over 40 years of experience in biosafety testing and product characterization, the new company will support the next wave of commercial cell therapies.

"CDMOs supporting the cell therapy industry have struggled to evolve from a small-scale cottage industry to deliver cost effective manufacturing at scale," said Iain Baird, chairman of Minaris Advanced Therapies. "Our mission is to solve the development and manufacturing challenges preventing these promising therapies from successful worldwide commercialization."

The team includes more than 1,400 industry professionals with deep scientific and regulatory expertise. The company's testing business unit provides unrivalled expertise in analytical method development and GMP-grade biosafety and product characterization testing services for both in-house and external programs.

"Minaris Advanced Therapies is designed to help the industry treat more patients by providing the experience, global footprint, and platforms to accelerate timelines and enable commercialization," said Eytan Abraham, Ph.D., chief commercial and technology officer. "Many of the technologies needed to reduce cost of goods sold and improve turnaround time already exist, we will drive their adoption and implementation at scale."

Built for speed, scale and science

Minaris Advanced Therapies brings together:

• More than 1,400 employees specializing in process and analytical development, manufacturing, quality control, quality assurance and regulatory compliance
• Facilities at six sites on three continents, totaling more than 730,000 square feet of infrastructure
• 42 state-of-the-art clean rooms for commercial use in Philadelphia, Allendale, NJ, Munich, and Yokohama, Japan
• Track record of more than 7,500 GMP batches released, with current manufacturing of two commercial products and testing of more than 27
• More than 20 successful inspections by global health agencies, including the FDA, EMA, TGA, PMDA, MFDS and USDA
• Over 40 years of biosafety and product characterization testing experience, with 1,700 assays developed, and 10,000 samples received annually
• 22 patents in discovery services, including key intellectual property for the TESSA^® platform for scalable AAV and XOFLX^™ packaging and producer cell lines for lentiviral vector production