ATMP Sweden ATMP Sweden Finalized initiatives CAMP CAMP Projects Next gen CAR-T

Next gen CAR-T

Fully closed (from vein to vein) automated CAR-T manufacturing process

The project aims to advance Eliera’s iTANK platform armed CAR(NAP)-T cells for cancer therapy. The project explores process development regarding two ongoing CAR-T therapies developed at Elicera and Uppsala University, ELC301 for treating B-cell malignancies and ELC401 for glioblastoma

Time period: 01/2024 – 12/2024

Lead: Uppsala University

Involved partners: Uppsala University, Vecura/Karolinska University Hospital, Elicera Therapeutics

Work plan:

  1. Fully Closed CAR-T Manufacturing Process MP2.0:
    • Develop detailed SOP for closed handling of materials from start to finish.
    • Ensure compatibility with CAR-T cell engineering and expansion processes.
  2. Implementation of MP2.0 in GMP Lab:
    • Set up closed manufacturing facilities at Vecura GMP lab.
    • Train personnel on the new closed system protocols and procedures.
    • Ensure compliance with regulatory standards and quality control measures.
  3. GMP Validation Dataset Package:
    • Collect comprehensive validation data, including process parameters, quality control results, and batch records.
    • Prepare a detailed validation dataset package in accordance with GMP regulations.
    • Initiate discussions with the Swedish Medicinal Product Agency (MPA) based on the validation package, exploring the possibility of delivering fresh CAR-T cells to patients.

Contact: Di Yu, Uppsala University / Elicera Therapeutics

Website: https://www.elicera.com/