Development of Small Molecule Formulations for Enhanced Production of CAR-T Cell Therapies

This project targets challenges in biomanufacturing of cell and gene therapies, addressing inherent complexities and variabilities in biologically based production systems.
Categories
Cell and Gene therapies

Industry Need

Manufacturing of CAR-T therapies is a complex process with high costs and variability that require limitations to be overcome – production of LVV and LVV transduction of target cells. 

Approach

  • Boosting LVV yields coupled with enhanced transduction efficiency can provide significant benefits for efficiency of CAR-T production, reducing manufacturing COGs, manufacturing timelines, overall product quality and patient access
  • Data package generated would provide test-case and GMP ready baseline process for more cost-effective production of cell therapies. This project will de-risk adoption of VSE™ by AstraZeneca and other developers of cell therapies
  • VSE™ formulations would be available for access by NIIMBL community and global biomanufacturing sector through supply agreement as appropriate
  • Reduction in the costs of therapies, improvements in quality of life for patients affected by chronic diseases and economic growth will all result from this project, and all align well with general government initiatives in Canada and the US.

Impacts

Boosting LVV yields coupled with enhanced transduction efficiency can provide significant benefits for efficiency of CAR-T production, reducing manufacturing COGs, manufacturing timelines, overall product quality and patient access

Data package generated would provide test-case and GMP ready baseline process for more cost-effective production of cell therapies. This project will de-risk adoption of VSE™ by AstraZeneca and other developers of cell therapies.

VSETM formulations would be available for access by NIIMBL community and global biomanufacturing sector through supply agreement as appropriate

Reduction in the costs of therapies, improvements in quality of life for patients affected by chronic diseases and economic growth will all result from this project, and all align well with general government initiatives in Canada and the US.

Outputs/Deliverables

  • 1.4. Deliverable Distribution of critical shared material, establishment of production and analytical SOPs.  
  • 2.4. Deliverable Formulation for enhanced production of LVV (3 cell lines)
  • 3.4. Deliverable Formulation for enhanced LVV transduction of T-cells
  • 4.3. Deliverable Partner verification of Segment 2 formulation in in-house platform
  • 5.4. Deliverable Partner verification of Segment 3 formulation in in-house platform
  • 6.4. Deliverable Partner verification of VSEformulations in end-to-end CAR-T production in clinical candidate with CQA analysis; benchmarked against standard process

Additional Project Information (Members Only)

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Project Lead

Virica Biotech Inc.

Virica Biotech Inc.

Participating Organizations

AstraZeneca

AstraZeneca

Sartorius Stedim

Sartorius Stedim