While challenges with commercial rollouts have been attributed to clinical site readiness, reimbursement coverage and accessibility, CGT drugs to date have predominantly targeted relatively small patient populations, effectively sidestepping a critical question: Are CGT manufacturing capabilities ...
This article describes the thought processes involved in defining control strategies across important areas including aseptic control, material control, process control, quality control and chain of custody control. We offer examples of how each of these elements should be developed and documented ...
Wednesday, March 05, 2025
To quote Astronomers Without Borders, “Boundaries vanish when we look skyward.” In a perfect world, this same philosophy would guide global access to cell and gene therapies.
Tuesday, February 25, 2025
As multiple stakeholders come at the problem from different angles, sustainable global access pathways are beginning to align. From process efficiencies aimed at reining in costs to innovative manufacturing and go-to-market models, cell and gene therapies are charting a course towards future ...
Tuesday, February 18, 2025
Biomarkers have become indispensable in the creation and optimization of cutting-edge treatments.
Tuesday, February 11, 2025
To benchmark the sector’s progress in the inaugural issue of Cell & Gene Therapy Review, we asked thought leaders a single question: What is the biggest challenge facing the CGT sector in 2025?
Monday, February 03, 2025
To benchmark the sector’s progress in the inaugural issue of Cell & Gene Therapy Review, we asked thought leaders a single question: What is the biggest challenge facing the CGT sector in 2025?
Monday, February 03, 2025
To benchmark the sector’s progress in the inaugural issue of Cell & Gene Therapy Review, we asked thought leaders a single question: What is the biggest challenge facing the CGT sector in 2025?
Monday, February 03, 2025
To benchmark the sector’s progress in the inaugural issue of Cell & Gene Therapy Review, we asked thought leaders a single question: What is the biggest challenge facing the CGT sector in 2025?
Monday, February 03, 2025
As we head into a new year, it’s time to look back at 2024 and appreciate the tremendous progress made in cell and gene therapy.
Thursday, January 02, 2025