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Updated: Sep 4, 2025
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Human Mesenchymal Stem Cell Processing for Clinical Applications Using a Closed Semi-Automated Workflow
Published on: March 17, 2023
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Automated closed volume reduction process for apheresis stem cell grafts: From development to clinical implementation
Anita Howell1, Brenda Letcher2, Kelly Murphy2
1Canadian Blood Services, Innovation and Portfolio Management, Ottawa, Ontario, Canada.
Transfusion
|July 19, 2022
Summary
Volume reduction of hematopoietic progenitor cells (HPC-A) using a closed, semi-automated system efficiently reduces dimethyl sulfoxide (DMSO) and optimizes freezer space. This method ensures high cell recovery and viability, meeting good manufacturing practice standards for autologous transplants.
Area of Science:
- Hematology
- Cellular Therapy
- Biotechnology
Background:
- High-volume hematopoietic progenitor cell apheresis (HPC-A) increases infused dimethyl sulfoxide (DMSO) and freezer storage needs.
- Volume reduction before cryoprotectant addition is key to mitigating these issues.
Purpose of the Study:
- To implement and evaluate a closed, semi-automated volume reduction process for HPC-A products.
- To assess the efficiency, reliability, and impact on cell viability and patient outcomes.
Main Methods:
- Developed a closed, semi-automated process using buffy coats from whole blood to create mock HPC products.
- Tested the process across various volumes and cell concentrations.
- Monitored process implementation concurrently.
Main Results:
- Achieved over 93% white blood cell and 91% CD34+ cell recovery.
- No significant loss in product viability or potency was observed.
- Infused cell doses supported timely neutrophil and platelet engraftment without increased adverse events.
Conclusions:
- The closed, semi-automated volume reduction system effectively processes HPC-A products.
- The process meets good manufacturing practice requirements for stem cell manufacturing.
- This represents a successful implementation in Canadian autologous transplant settings.
