QC and logistics

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

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.

Interview with project leader

Hi Jim Lund!

What is the need your project addresses?

Advanced therapies are very different in terms of logistics and quality control as compared to small molecular based drugs. To ensure safe and efficient delivery to these products to patients these issues needs to be addressed.

What is your approach to meet the need?

To ensure that we solve real and relevant problems we will work with a product that is already approved in Japan. We will make protocols, relevant transport missions and SOPs based on the specific properties of that product. We will select and validate a shipment vessel with relevant environmental parameters in order to address the risk associated with shipping this product.

How will this improve Sweden´s capabilities within ATMPs?

Other products will similar characteristics and needs will be able to use the information and protocols that is developed in this project. This will ensure that at least some Swedish products can be shipped to hospitals throughout Europe which would allow for European multiple center clinical trails in the future.

For more information please contact Jim Lund