Finally, I’m attending ARM’s Meeting on the Mesa this week. I like to meet our readers in person and to learn about their roles in the cell and gene sector. Email me or Tweet me if you’d like to connect at the conference. I hope to see you there!
By Herman F. Bozenhardt and Erich H. Bozenhardt,Integrated Project Services (IPS)
Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.
Single-use connection technologies are expected to play a critical role in commercial manufacturing of cell and gene therapies. Learn about the types of connection technologies and selection considerations.
By Devina Ramsaroop, Steven Loo Yong Kee, Danylo Sirskyj, Calley Hirsch, Elizabeth Csaszar, and Aaron Dulgar Tulloch,GE Healthcare Life Sciences
Challenges to overcome in the CAR T manufacturing process include lengthy production times (11 - 21 days), product variability associated with open handling steps, and high manufacturing costs. Here we examine and evaluate individual CAR T cell unit operations, commercial reagents, and equipment with process closure potential to develop an improved workflow and increased product consistency.