The "Cell Therapy Human Raw Materials Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031" has ...
Reducing manual touchpoints is an important part of supporting more consistent and scalable manufacturing processes.
GlobalData on MSN
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.
Lumacyte CEO on how real-time insight is driving down manufacturing failures and opening doors for more patients.
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...
Pharma and advanced therapy manufacturing will only grow more complex in science, regulation, and global scale. But the ...
Cellares, the contract drugmaker known for its cell therapy factory-in-a-box, will expand its operations to Europe after ...
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 ...
Regulatory authorities emphasize integrated control strategies, but CAR-T specification setting requires balancing data rigor with regulatory flexibility.
- 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 ...
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 ...
Novo Nordisk has found a buyer for cell therapy technologies dropped in its retreat from the modality. Aspect Biosystems has ...
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