CMC deliverables must be addressed to continue CGT momentum, but overcoming talent gaps will give firms the competitive edge, says former Spark Therapeutics CTO Cynthia Pussinen. With 10 approvals in the US and Europe last year, there is little doubt the cell and gene therapy (CGT) sector is blossoming. Consultant Cynthia Pussinen described the sector as having “lifted off and in flight” at Phacilitate’s Advanced Therapies Week earlier this month, with much progress including “truly rewriting how patients are treated…

Catalent has designed a case management service, which aims to tackle challenges associated with the safety and timeline of cell and gene therapy programs. Contract development manufacturing organization (CDMO) Catalent says the complex nature associated with delivering doses of cell and gene therapies (CGTs) means the products need to be managed correctly and efficiently to reduce the risk of production schedule disruption and administration of the therapy to the individual. The launch of the company’s case management service looks to…

Researchers led by the University of Texas MD Anderson Cancer Center have developed a delivery system for mRNA using extracellular vesicles (EVs). The study, published in Nature Biomedical Engineering, details how the researchers used EV-encapsulated messenger RNA (mRNA) to produce collagen for numerous months in the cells of photoaged skin. The researchers claim this is the first therapy that represents a proof-of concept for using EV mRNA therapies. EVs are small structures formed by cells that transport biomolecules and nucleic…