FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

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

Single-use systems streamline CGT manufacturing by reducing cleaning validation and enabling quick changeovers, essential for ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: Analysis and Forecast, 2024-2033" report has been added to ResearchAndMarkets.com's offering. The Asia-Pacific ...

Out of the shadows, new CDMO Artis BioSolutions has decloaked on a mission to tackle the tricky production process for advanced therapeutics. Artis officially emerged from stealth on Wednesday, ...

Data indicate that the AutoCell platform could pave the way for CGTs for the first time as first-line therapies.

In the complex process of producing a gene therapy, bioprocessors depend on assays to monitor the attributes of the product at various stages. Scientists at Thermo Fisher Scientific focus on ...

This article explores the US and EU compliance requirements to ensure patient safety for GMP ancillary materials in cell and ...

Cell and gene therapy (CGT) has evolved from a niche research pursuit into a central force in biopharmaceutical innovation. By engineering living cells and genetic material to repair or replace faulty ...

Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing ...