As the therapeutic potential of AAV gene therapy becomes increasingly evident, so does the demand for its widespread application; however, this surge in demand poses a formidable challenge in the need for increasingly scalable and efficient AAV production platforms. Leveraging recent advances in ...
An effective orchestration platform is now essential in optimizing processes, fostering collaboration, and ensuring the safe and effective administration of CGTs. These orchestration platforms are crucial tools for approved treatment center staff to navigate the complex processes involved in CGT ...
To scale up a process, there are several important considerations, starting with the selection of a target batch size. However, process scale-up can encounter challenges. Here, several key considerations will be discussed, and specific examples of potential challenges faced during the scale-up of ...
Wednesday, March 19, 2025
Immunotherapy has transformed the field of oncology by harnessing the immune system’s innate ability to mount targeted attacks on cancer cells. Building on this foundation, cell and gene therapies take immunotherapy to the next level by reprogramming genetic blueprints and engineering immune cells ...
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