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 ...

Lumacyte CEO on how real-time insight is driving down manufacturing failures and opening doors for more patients.

Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, ...

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 ...

Cellares, the contract drugmaker known for its cell therapy factory-in-a-box, will expand its operations to Europe after ...

- 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 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 ...

Ori Biotech has lassoed a significant milestone for its space- and cost-efficient cell and gene therapy manufacturing platform. The FDA has granted the company’s IRO platform an Advanced Manufacturing ...

The cell and gene therapy sector has never lacked attention, but all too often, the narrative swings from one extreme to ...

"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...

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 ...