IPC/QC Of Gene-Engineered HSCs Manufactured By The CliniMACS Prodigy®

In-process and quality control (IPC/QC) are essential for ensuring the consistent and reliable manufacturing of gene-engineered hematopoietic stem cells (HSCs). The CliniMACS Prodigy HSC Engineering process facilitates the production of these gene-engineered HSCs through viral transduction of human CD34+ cells. This process is enhanced by the inclusion of integrated sampling pouches within the CliniMACS® Tubing Sets, which allow for control sampling at any stage of the manufacturing process.

Viral transduction of CD34+ cells represents a promising therapeutic approach for a range of inherited disorders, including sickle cell disease, β-thalassemia, and primary immunodeficiencies. For in-process control (IPC), key parameters such as cell viability over time and cell recovery rates were meticulously monitored. Quality control (QC) assessments focused on evaluating the functionality of the gene-engineered HSCs through phenotypic analysis of markers such as CD34 and CD90, as well as colony-forming unit (CFU) assays.

These comprehensive IPC/QC protocols ensure that the gene-engineered HSCs produced are not only consistent in quality but also effective in their intended therapeutic applications. By maintaining stringent control over the manufacturing process, the CliniMACS Prodigy HSC Engineering process stands as a robust method for producing high-quality gene-engineered cells.

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