By Dr. Barbara M. Fischer, Process Consultant & Senior Sales Application Engineer
The scale-up needed to successfully commercialize cell and gene therapies is highly challenging. The CGT production process requires a specialized environment to ensure high-quality personalized therapies that cannot be provided in traditional large volume manufacturing sites. Additionally, the supply chain management for CGTs will become increasingly complex to sustain their specific requirements.
A much-needed approach to solving problems related to supply chain management is the development of smart packaging and related smart technologies. Ideally, smart packaging enters the picture in the very first steps of CGT production, e.g. during cell collection for CAR T therapy. It should be easy to use for personnel in the clinical setting, e.g. taking care of convenient labeling or tagging of vials and bags and allow for fast, controlled freezing to enter the cold chain. During the shipment, it should monitor, and transmit physical variables such as temperature, location tracking, orientation and shocks and send push notifications to stakeholders when exceeding certain predefined limits to allow rapid intervention. Moreover, it should reliably protect the contents from impacts, shear forces and tearing.
The scalability of cell and gene therapy depends on innovative smart packaging companies.