POSTmark CAR-T: Delivering Therapies Without Delay

The complexities of bringing a CAR T-cell therapy from research to the clinic often result in significant manufacturing delays. Because these personalized cell therapies are "living medicines," the final product is inseparable from its intricate process. Any discontinuity—such as the inherent variability when moving an autologous workflow from a research lab into a cGMP environment—can compromise product comparability, trigger regulatory issues, or halt clinical trials entirely.

To overcome this persistent bottleneck, innovators are adopting integrated development strategies that guarantee continuity and speed. A critical approach involves establishing identical, or 'mirrored,' non-GMP and cGMP systems, ensuring early-stage data is directly transferable and regulatory ready. Furthermore, co-locating vector production and cell manufacturing under a single quality system eliminates complex vendor hand-offs and preserves critical timelines. Understanding these integrated pathways is key for companies aiming to streamline development and deliver life-saving therapies without delay. Read the full article to discover how integrated development pathways solve manufacturing continuity challenges.