Cell Therapy

Cell therapy products are both critical and very expensive.  After manufacture, they are often stored in LN2 freezers to ensure their functionality is preserved.  This is normally done in a manual freezer with little to no controls, integrated monitoring, or access management.  The financial worth (inventory) of an LN2 freezer full of cell therapy products can easily be in the millions. These products, when stored in traditional freezers, will additionally experience undocumented transient warming events as adjacent products are accessed.  Brief transient exposures can be fine, but excessive ambient exposures will cause micro warming events which can change the viability and recovery of the final product.  Based on the importance to the patients and financial worth of the cell therapy products in storage, the access, inventory, temperature, and exposure times should all be controlled, monitored, tracked and auditable.  Kryeros offers a portfolio of cryogenic storage and transport solutions to control, monitor, audit, and manage cell therapy storage to ensure cell therapy products' value and functionality is preserved.

Additionally, the regulatory environment is significantly different from the traditional modality of cryogenic storage. The requirement for documentation and qualification packages is such that traditional manufacturers and their distribution find it difficult if not impossible to support.

Kryeros can provide support to define, prepare, and execute URS, DQ, RA, IQ, OQ, PQ packages to support cold chain design for critical processes.