Lumacyte CEO on how real-time insight is driving down manufacturing failures and opening doors for more patients.
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.
Universal gene‑edited CAR‑T therapies turn donor T cells into off‑the‑shelf cancer treatments, cutting delays and costs while ...
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...
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 ...
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 ...
- 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 ...
With the power of robotics and the personalized medicine expertise of one of Japan's top drugmakers, Astellas Pharma and Yaskawa Electric Corporation are setting off on a joint venture to help ...
The cell and gene therapy sector has never lacked attention, but all too often, the narrative swings from one extreme to ...
Novo Nordisk has found a buyer for cell therapy technologies dropped in its retreat from the modality. Aspect Biosystems has ...
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