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 ...
A roundtable discussion reveals how hybrid distributed models could provide a bridge from centralized cell-therapy ...
Officials at Mytos, which is automating cell manufacturing, launched its automated contract development and manufacturing organization (CDMO), offering to overcome one of what they call regenerative ...
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.
Chimeric antigen receptor (CAR) -T-cell therapies have yielded remarkable results in the treatment of hematological malignancies. Several autologous CAR T-cell products have received marketing ...
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