In January 2024, the FDA updated its guidance on CAR-T therapies, emphasizing the need for enhanced safety and quality measures. This update followed a series of warnings regarding the risk of T cell ...

Biologists have uncovered a quality control timing mechanism tied to cell division. The 'stopwatch' function keeps track of mitosis and acts as a protective measure when the process takes too long, ...

In the race to bring new biologics to market, development teams are constantly balancing speed, quality, and regulatory ...

This review article highlights the transformative potential of in vivo CAR T cell therapy in addressing the limitations of traditional CAR T cell production. This innovative approach could ...

Techne, bioMerieux, Roche, Lonza Group, Miltenyi Biotec India and More Cell and Gene Therapy Manufacturing QC Market Cell and ...

The host cell system is a critical determinant of recombinant protein quality and yield, with direct influence on protein folding and post-translational modification factors that shape the ...

In-house manufacturing is a good option for cell and gene therapy (CGT) developers, according to researchers who say that, as well as providing better supply chain control, the approach is free of the ...