As logic-gated CAR-Ts advance into human studies, the field is moving toward multi-layered platforms that integrate Boolean logic, microenvironmental sensing, enhanced trafficking, and dynamic control of T-cell behavior, with the goal of delivering safer, more durable, and scalable therapies for ...
Some of the most actionable levers may sit earlier in the process than the industry has been looking.
A clear CMC roadmap is critical as global regulators expect to see not only a snapshot of current controls but a clear path showing how a process will mature and scale throughout development and commercialization.
Laboratory management software can’t build a perfectly optimized construct for an in vivo CAR-T cell therapy, but it can make the lives of the scientists doing so considerably easier.
When you combine an ethical, plentiful human tissue source with disciplined manufacturing and true codevelopment partnerships, you get a realistic way to scale human-derived biomaterials.
The real risk is not that one country pulls ahead. It’s that friction — political, regulatory or economic — slows the system as a whole.
The American Society for Clinical Oncology annual meeting never fails to deliver inspiring advances in cancer-care.
In theory, in vivo makes other cell therapies obsolete, but a panel at BPI Europe in Vienna last month painted a more measured picture.
Here are 10 best practices that can help drug developers avoid delays, protect data quality, and meet regulatory, clinical and manufacturing expectations.
Developers who treat China’s rise as a strategic opportunity — both for partnership and as a wakeup call to address inefficiencies in Western systems — will be best positioned to take home the ultimate prize: bringing lifesaving treatments to more patients.