The CliniMACS Prodigy® Hematopoietic Stem Cell Engineering (HSCE) process automates manufacturing of gene-engineered hematopoietic stem cells (HSCs) by viral transduction of CD34+ cells. Manufacturing takes place in sterile and single-use tubing sets connected to the CliniMACS Prodigy Instrument, providing a functionally closed system. Its robust performance reduces donor variations while the flexible software allows for easy conversion of manual processes.
Viral transduction of CD34+ cells is a promising approach for treating inherited disorders such as sickle cell disease, ß-thalassemia, or primary immunodeficiencies (de Dreuzy E. et al. 2016; Lebensburger, J. and Persons D.A. 2008; Papanikolaou E. and Anagnou N.P. 2010). The CliniMACS Prodigy® HSC Engineering process allows for manufacturing of gene-engineered HSCs from human CD34+ cells.
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, single-use tubing sets, ensuring highly reproducible and standardized manufacturing processes.
The CliniMACS Prodigy HSC Engineering process automates the viral transduction of HSCs in a functionally closed system based on sterile and single-use tubing sets.
The CliniMACS Prodigy HSC Engineering process automates the manufacturing of gene-engineered HSCs by viral transduction. This process will standardize and facilitate the clinical research of inherited disorders.
The CliniMACS Prodigy HSC Engineering process 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, then connected to the CliniMACS Prodigy Tubing Set (TS) 520.
CD34+ cells are pre-cultivated in HSC-Brew GMP Medium supplemented with MACS® GMP Recombinant Human Cytokines (SCF, TPO, Flt3-Ligand, and IL-3). Our MACS GMP Products are manufactured and tested under a quality management system (ISO 13485) and are compliant with relevant GMP guidelines.
After pre-cultivation, the CD34+ cells are transduced with lentiviral vector and when needed, can be repeated to increase transduction efficiency.
After transduction, the final cell product containing gene-engineered HSCs is washed twice and harvested in a 100 ml buffer of your choice. The gene-engineered HSCs are then ready for further processing, e.g., cryopreservation, or functional testing.
In-process 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 throughout the cell manufacturing process. Miltenyi Biotec provides complete solutions with its MACS Flow Cytometers and a wide portfolio of MACS IVD Antibodies that are produced to 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.
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