It's an exciting time to be in cell therapy manufacturing and commercialization, particularly in the oncology space. This year alone, we've seen the US approval of three cell therapy products: Iovance ...
With an increasingly promising roster of approved cell therapies still burdened by complex manufacturing, multiple companies ...
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 ...
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 ...
Automation, decentralized manufacturing, and supportive regulations are helping to surmount technical difficulties in cell and gene therapy manufacturing.
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