Labeling at the ultracold temperatures often required for cell and gene therapies adds significant complexity in your primary and secondary packaging and labeling considerations. The labels you select must be validated to perform at these ultracold temperatures, and the details of the application process or container type can have a dramatic impact on long-term adherence. This, coupled with the personalized nature of these medicines, and the limited options for over-labeling once the materials are frozen, mean that selecting the right label the first time is extremely important.
Leverage our clinical labeling services for customized, flexible solutions and strategies for your primary and secondary packaging needs. We are the leading supplier of clinical labeling design, production and management services for cell and gene therapy manufacturers. Our team will work with you to develop a primary and secondary labeling strategy to account for variable dosing, blinding requirements, or patient specific information. Translations and regulatory guidance ensures global scalability of your trial activity. Primary labels can be developed and dispatched directly to the manufacturing facility, while secondary labels can be applied just-in-time for rapid deployment to clinical sites.
Secondary packing is often required in the cell and gene therapy space, not only to act as containment for hazardous material, but also to hold the secondary label. Our team offers standard and customized secondary packaging solutions for vials, bags, and other container types, and can be configured to address variable dosing strategies—which are common in early phase trials. All packaging and labeling is conducted at temperature, ensuring that your product does not experience any time out of environment as it is prepared for shipment. We can also conduct label validation studies specific to your container type and selected label in order to ensure long-term adherence.
Patient enrollment can be challenging in cell & gene therapy clinical trials, and when patients are enrolled, it’s often critical to dispatch drug product as soon as possible for administration. Just-in-time packaging and labeling is critical to meeting this patient need, and Thermo Fisher Scientific can develop customized workflows based on your processes to get drug product out the door in as little as a few hours.
As you’re preparing for the transition from clinical trials to commercial approval, our team has the expertise, equipment, and processes to adapt your clinical program to commercial regulations in the US and EU. From artwork design services to serialization equipment and software to comply with the Drug Supply Chain and Security Act (DSCSA) requirements and the Falsified Medicines Directive (FMD), our team understands what it takes to enable a successful commercial launch. Our cryocenters in the US and EU offer integrated commercial packaging services and distribution services, ensuring material integrity, traceability, and regulatory compliance from manufacturing site to patient bedside.
Have a question about our packaging and labeling solutions for cell and gene therapy? Contact us.
Walk through key considerations for developing a successful logistics strategy for the management of cell-based material.