Optimisation and quality control of cell processing for autologous stem cell transplantation

Area of Science:

• Cellular therapy
• Transplantation immunology
• Biotechnology

Background:

• Autologous stem cell transplantation (ASCT) practices have evolved significantly over 20 years.
• External regulations have enhanced ASCT quality and safety, yet variable practices persist.
• Clinical incidents reveal specific risks associated with current cell processing and storage.

Purpose of the Study:

• To review current quality control expectations in cell processing for ASCT.
• To address limitations of existing viability assays for hematopoietic progenitor cells.
• To emphasize the need for improved functional assays for cell product potency.

Main Methods:

• Review of clinical practice and technological advancements in cell processing for ASCT.
• Analysis of quality control measures and regulatory impact.
• Evaluation of current assays for assessing hematopoietic progenitor cell viability and function.

Main Results:

• Existing viable CD34+ cell assays may not accurately reflect progenitor cell function post-storage, especially after cryopreservation.
• There is a critical need for a real-time functional assay to replace traditional colony assays.
• Prompt and reproducible engraftment remains the key indicator of cell product potency.

Conclusions:

• Current quality control for ASCT requires enhancement to ensure product efficacy and patient safety.
• Development of novel, real-time functional assays is crucial for accurate assessment of cell product quality.
• Close monitoring of engraftment is essential for validating successful cell processing and transplantation outcomes.