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FDA increases manufacturing flexibility for cell and gene therapies
Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...
Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, ...
Lumacyte CEO on how real-time insight is driving down manufacturing failures and opening doors for more patients.
Cellares, the contract drugmaker known for its cell therapy factory-in-a-box, will expand its operations to Europe after ...
Kincell Bio, a leading contract development and manufacturing organization (CDMO) in cell therapy, today announced the ...
The first half of 2025 has been a notable one for Cellares. The cell therapy manufacturer operates its first commercial-scale Integrated Development and Manufacturing Organization Smart Factory in ...
- Joint venture will aim to develop a cell therapy manufacturing platform through robotics and will offer access to startups and academic institutions - In the pharmaceutical industry, the ...
Akadeum Life Sciences, the leader in buoyant microbubble cell separation, today announced that its Chief Executive Officer Brandon McNaughton, PhD, will present at Biotech Showcase (TM) 2026 in San ...
The cell and gene therapy sector has never lacked attention, but all too often, the narrative swings from one extreme to ...
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 ...
The "Cell Therapy Processing: Global Markets and Technologies" report has been added to ResearchAndMarkets.com's offering. The global market for cell therapy processing is estimated to grow from $2.7 ...
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