QC and logistics

Subproject – Establishing a QC and logistics strategy of cell-based products for secure patient treatment.

Subproject – Establishing a non-dry ice dependent logistics strategy for cell therapies

Lead: RISE – Jim Lund

Involved partners: CellSeed Sweden AB, Karolinska University Hospital, YSDS AB

The project aims to create a “generic transport and distribution cook-book” with CellSeed product as a test case. This includes;

  • Specification of key characteristics for different types of ATMPs, including methods for analyzing and evaluating these
  • Increased knowledge of mechanisms and kinetics of changes in key characteristics of selected ATMPs
  • Materials and protocols for storing and transporting ATMPs with retained key characteristics
  • Explore new approaches for real-time monitoring of storage and transportation conditions of ATMPs

Examples of tasks and actions:

  • Establishment of a FACS method to use as QC test for release testing after production
  • Transport simulations by standardized test methods and defined test levels based on collected real situation data rather than standards.
  • Identifying and validating the transportation value chain for this product.