Manufacturing of gene-engineered hematopoietic stem cells

  • Automated viral transduction of hematopoietic stem cells in a functionally closed system based on sterile and single-use tubing sets
  • Robust performance independent of donor
  • Highly efficient process

Simplify the manufacturing of gene-engineered hematopoietic stem cells with the CliniMACS Prodigy® HSC Engineering System

Viral transduction of CD34+ cells is a promising approach for treating inherited disorders such as sickle cell disease, ß-thalassemia, or primary immunodeficiencies 1,2,3. The CliniMACS Prodigy® Hematopoietic Stem Cell Engineering (HSCE) System allows for manufacturing of gene-engineered hematopoietic stem cells (HSCs) from human CD34+ cells.

Stepwise procedure to manufacture gene-engineered HSCs

The CliniMACS Prodigy Cell Manufacturing Platform automates the generation of gene-engineered HSCs by viral transduction in a functionally closed system. All steps are automated and manufacturing takes place in sterile and single-use tubing sets, ensuring highly reproducible and standardized manufacturing processes.

1. Preparation of CD34+ cells as cellular starting material 

The CliniMACS Prodigy HSCE System uses human CD34+ cells as cellular starting material. They can be easily enriched from mobilized leukapheresis with the CliniMACS Prodigy or the CliniMACS Plus Instrument. Enriched CD34+ cells are transferred to a cell bag, which needs to be connected to the CliniMACS Prodigy Tubing Set (TS) 520.

Related videos:

How to enrich CD34+ cells from blood products with CliniMACS Technology?

2. Transduction of HSCs

CD34+ cells are resuspended in HSC-Brew GMP Medium supplemented with MACS® GMP Recombinant Human Cytokines (SCT, TPO, Flt3-Ligand and IL-3) and transduced with lentiviral vector. The transduction step can be repeated, if necessary, to increase transduction efficiency.

3. Harvest of gene-engineered HSCs

After transduction, the final cell product containing gene-engineered HSCs is washed twice and harvested in 100 mL buffer of your choice. The gene-engineered HSCs are then ready for further processing, e.g., cryopreservation, or functional testing.

Express Modes of the MACSQuant® Instruments allow for fully automated and standardized flow cytometry processes.

In-process and quality control and clinical flow cytometry

In-process control and quality control (IPC/QC) are required for consistent cell manufacturing. Integrated sampling pouches on the CliniMACS Tubing Sets allow for controls to be collected at any time during, and at the end of the cell manufacturing process. Miltenyi Biotec provides complete solutions with its MACS Flow Cytometers and a wide portfolio of MACS IVD Antibodies. MACS IVD Antibodies are produced according to the quality management system ISO 13485.

When using a MACSQuant® Instrument, Express Modes allow you to fully automate and standardize your flow cytometry process. The MACSQuant Instrument and the MACS Flow Cytometry portfolio are for research use only.


  1. Lebensburger, J. and Persons D.A. (2008) Curr. Opin. Drug Discov. Devel. 11: 225–232.
  2. Papanikolaou E. and Anagnou N.P. (2010) Curr. Gene Ther. 10: 404–412.
  3. de Dreuzy E. et al. (2016) Biomed. J. 39: 24–38.

Related information

Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic or diagnostic use. For complete regulatory notes, please click here.

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