Single-Use Systems In Cell And Gene Therapies

Ensuring that cell and gene therapy products are shipped at cold temperatures with robust controls is, if anything, even more important for cell and gene therapy products than it is for more traditional biopharmaceutical products because they are complex biological systems and you really don’t want to take any risks of them being disrupted during storage and shipment. In addition sterility and the aseptic nature of processing is so critical. For a cell therapy product you can’t do sterile filtration at the end of your manufacturing process, so integrating aseptic processing into every stage of manufacturing is far more critical compared to, for example, monoclonal antibodies where you have the benefit of being able to do a sterile filtration step at the end.

In this Q&A with Katy Spin, Chief Operating Officer and Managing Partner at Dark Horse Consulting Group, she shares her expertise in efficient solutions for fluid management and innovative logistic solutions in the cell and gene therapy sector as well as her professional insights on topics including the usage and future of single-use systems in the space of cell and gene therapies.