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Ensuring viral safety in advanced therapies
Wednesday, October 15, 2025
Viral clearance studies, long a cornerstone of biologics production, are now being reevaluated and adapted for genetically engineered viral vectors and vector-derived ... read more
A standardized approach to CGT quality management
Wednesday, March 05, 2025
This article describes the thought processes involved in defining control strategies across important areas including aseptic control, material control, process control, ... read more
Using rapid microbiological methods to ensure product safety
Friday, November 22, 2024
How flexible rapid testing can serve the different needs of cell and gene therapy manufacturers read more
How preservation equipment can mitigate risk in CGT research
Wednesday, November 06, 2024
The limitations of current preservation approaches are driving researchers toward new alternatives read more
Maintaining contamination control in advanced therapy manufacturing
Wednesday, November 06, 2024
Facilities that make cell and gene therapies require cleaning and disinfection strategies not found at other drug manufacturing sites read more

March Bio doses first T-cell lymphoma patient with CD5 CAR-T
MB-105 employs a proprietary CAR design that enables selective targeting of malignant cells while preserving normal T-cell function.
Thursday, April 24, 2025
Sarepta reports Elevidys patient death, citing acute liver failure
While acute liver injury is a known possible side effect, acute liver failure leading to death represents a severity not previously reported for Elevidys.
Tuesday, March 18, 2025
CMO Symbiosis completes gene therapy-focused FDA inspection
The UK-based CMO has successfully completed its latest inspection by the U.S. FDA of its facilities in Scotland.
Monday, March 03, 2025
Solvias opens flagship site in Research Triangle Park
The Switzerland-based CRO has opened the doors to its flagship North American site — the Center of Excellence for Biologics and Cell and Gene Therapy
Monday, January 27, 2025
Roche, Dyno partner on AAV gene therapy vectors for neurological diseases
In a deal that could exceed $1 billion, Roche’s bets on Dyno’s platform and sequence design technologies enabling in vivo gene delivery.
Thursday, October 24, 2024