CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cellino, a leader in advanced biomanufacturing, today announced that its optical biomanufacturing technology for generating induced pluripotent stem cells (iPSCs) ...

PHILADELPHIA, Nov. 18, 2025 /PRNewswire/ -- BlueWhale Bio, Inc., a company dedicated to transforming immune cell therapy manufacturing, today announced that its Synecta™ cell-derived nanoparticle ...

Gene therapy developers and manufacturers adopting NanoMosaic's platform gain access to enhanced FDA engagement and expedited IND/BLA review. The FDA AMT designation verifies NanoMosaic platform's ...

In December 2024, the FDA launched the Advanced Manufacturing Technologies Designation Program, or AMT Designation Program, to modernize pharmaceutical manufacturing and address critical challenges, ...

The designation covers Bright Path's end-to-end U.S. production of two hospital medicines in chronic shortage, the first proof that essential medicines can be made in America, in most cases at prices ...

Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, today announced that the IRO(R) platform has received Advanced Manufacturing Technology (AMT) designation from the U.S.

To qualify for advanced manufacturing technology designation from the FDA, a company must present a manufacturing approach that incorporates a new technology or uses an established technology in a ...

Launched in 2024, IRO is one of the first technologies to receive AMT designation, validating the platform as a leading, next-generation solution for overcoming the critical challenges in cell and ...