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 ...
The AMT designation gives Cellares’ clients using the Cell Shuttle priority review with the FDA leading to accelerated regulatory filings SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the ...
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.
A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s Cellares has passed another major production milestone. Cellares’ automated ...
The FDA’s Center for Biologics Evaluation and Research (CBER) granted NanoMosaic’s request for an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle technology for multiplex ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results