Manufacturing gene-engineered T cells

T cell transduction (TCT) on the CliniMACS Prodigy

CliniMACS Prodigy T Cell Transduction Process
 

With the CliniMACS Prodigy T Cell Transduction Process you can now generate gene-modified T cells in a simple and fully automated way. Easy to use, this unique process will surely change the way you work. 

The CliniMACS Prodigy Platform enables the entire workflow for the manufacture of CAR T cells, from T cell selection through to cell formulation. Importantly, all cell processing steps are completely automated, ensuring a highly reproducible and standardized manufacturing process. During the TCT process, T cells are enriched by specific selection on day 0 (D0) and then activated overnight. On D1 T cells are transduced with a (lentiviral) vector. Subsequently, transduced T cells are expanded to the desired cell number for final cell formulation (D10–14).

For the manufacture and use of gene-engineered T cells, national and international legislation and regulations must be followed. Miltenyi Biotec as the provider of products for the TCT process does not give any recommendation regarding the use of the manufactured cells for therapeutic purposes and does not make any claim regarding a clinical benefit.

Cell separation on the CliniMACS Prodigy is a simple and easy method to magnetically isolate T cells with high purity. Advantages of this completely automated method include:

• Efficient isolation of CD4⁺ and CD8⁺ cells without inducing activation
  
• Removal of contaminating immune cells to enhance T cell transduction efficiency
  
• No magnetic bead removal necessary
  

GMP-compliant activation and expansion of T cells

Lentiviral vectors for T cell transduction

Lentigen Technology Inc., a Miltenyi Biotec company, integrates LV manufacturing competency into the CliniMACS Prodigy workflow solutions for the production of gene-modified cell therapy products. Located right outside of Washington DC, the 34,000 ft² facility has two cGMP ISO7 lentiviral vector production suites and offers a serum-free manufacturing process on 50 L to 400 L scale. The products and services provided by Lentigen Technology Inc. include:

• Customized lentiviral vectors (LVs) for translational research in cell and gene therapy
  
• Expert design and development of LVs for different target cell applications
  
• Suitable for Miltenyi Biotec’s integrated and automated workflow solutions such as CAR T cell production
  
• Commercial-scale manufacturing coming soon
  
  For EU: Please check with your regulatory authority for specific guidance on your investigational product.
  For US: Unless otherwise indicated, Lentigen products are for research and investigational use, only. Investigational use is allowed under approved IND-application, only.
  

References

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2. Maus, M.V. et al. (2014) Blood 123: 2625–2635.
3. Barrett, D.M. et al. (2015) J. Immunol. 195: 755–761.
4. Whilding, L.M. and Maher, J. (2015) Mol. Oncol. 9: 1994–2018.
5. Mock, U. et al. (2016) Cytotherapy 18: 1002–1011.
6. Priesner, C. et al. (2016) Hum. Gene Ther. 27: 860–869.