WP05 - Development and production of Streptamer reagents and corresponding GMP cell products

Objectives of the workpackage

  • Generation and testing of the multispecific MHC class I Streptamer products
  • Generation and testing of Fab Streptamer product for isolation of primary regulatory T cells
  • Generation of validated GMP compliant cell selection processes for multispecific T cell product and for the pT-reg product
  • Production of clinical Streptamer reagent sets as well as the corresponding multispecific T cell- and pT-reg product for the for the anticipated clinical trials

Workpackage description

The work package comprises Juno Therapeutics GmbH (JUNO)´s production of Streptamer reagents for the multispecific T cell product and pT-reg cell product, and their delivery to Leiden University Medical Center (LUMC) and Anthony Nolan London (AN) respectively. LUMC and AN will develop a selection process and quality control procedures for the respective cell product. This know-how will be transferred to JUNO to enable JUNO to establish clinical grade selection sets for the developed processes. In addition, this know-how will also be transferred to the Universitätsklinikum Würzburg (UKW) for generating the documentation for the clinical trials.

JUNO will validate the selection kits for GMP compliant selection procedures and utilize these selection methods for the production of the therapeutic cell products at its GMP unit in Munich and in the LUMC facilities. The cell products will be delivered from Munich to the consortium partners for treatment of the patient within the clinical trials.