Ori Biotech is a manufacturing technology company founded by scientists and built by life-sciences veterans to tackle the difficulty of making cell and gene therapies broadly available. Its IRO® platform helps therapy developers move from early research into GMP production with more consistent, scalable processes. Launched in 2024, IRO® has received the FDA’s Advanced Manufacturing Technology designation and has been used in a clinical program that reached first patient dosing.
FDA Advanced Manufacturing Technology (AMT) Designation
Compliance program
21 CFR Part 11 Compliant
Compliance program
FDAAMTDESIGNATION
Quality certification
Minaris Advanced TherapiesBorn from the 2025 combination of Minaris Regenerative Medicine and WuXi Advanced Therapies, Minaris Advanced Therapies is a global contract development and manufacturing organization serving developers of cell and gene therapies. Its identity rests on a long technical lineage: more than 25 years in therapy manufacturing, over 40 years in advanced testing, and a history that includes producing the first GMP cell therapy lot in the United States in 2004. The company now supports programs from early development through commercial supply across facilities in North America, Europe and Asia.PHILADELPHIA, PA
Volta TherapeuticsVolta Therapeutics creates an automated, closed system cell therapy manufacturing technology that brings GMP suites directly to the clinic. The company provides capacity, automation, and customization through continuous manufacturing devices to facilitate streamlined GMP cell therapy manufacturing.MARS, PA
ResilienceNational Resilience, Inc. is a technology-focused biomanufacturing company founded in 2020 to broaden access to complex medicines and strengthen biopharmaceutical supply chains. It operates an end-to-end manufacturing network across North America, supporting development and production of medicines from early phase through commercial manufacturing. Its facilities produce drug substances and drug products, including cell therapies and vaccines.BLUE ASH, OH
Innovative Cellular TherapeuticsHeadquartered in Rockville, Innovative Cellular Therapeutics is a private clinical-stage biotechnology company developing cellular immunotherapies for solid tumors. Its proprietary CoupledCAR® platform underpins individually made CAR-T therapies, including the lead GCC19CART program being studied for relapsed or refractory metastatic colorectal cancer. Founded by Larry Lei Xiao and Zoe Zhao Wu, ICT combines more than 20 years of stem-cell, cell-therapy and gene-editing experience with FDA cellular-therapy review expertise.ROCKVILLE, MD