Research Information System
4th International Conference on Chemistry and Chemical Engineering, Paris, France, 21 - 22 July 2025, pp.43-44, (Summary Text)
Abstract: The reliability and safety of cell-based therapies hinge on rigorous quality
control measures, particularly in identifying and mitigating residual impurities that may
impact therapeutic performance. Residual proteins originating from culture systems,
enzymatic treatments, and purification processes pose significant risks, potentially
triggering immunogenic responses, altering cellular functionality, or compromising
batch-to-batch consistency. As regenerative medicine advances, ensuring a standardized
and analytically robust approach to impurity detection is crucial for regulatory
compliance and clinical success. This presentation takes a broad analytical perspective
on quality assessment in cell-based therapy manufacturing, highlighting key
methodologies for impurity detection with a focus on electrophoretic and
chromatographic techniques. By drawing from our recent study on sodium dodecyl
sulfate-polyacrylamide gel electrophoresis (SDS-PAGE)-based residual trypsin and
trypsin inhibitor analyses in bone marrow-derived mesenchymal stem/stromal cell (BMMSC)
products,the speech examines the practical applications, advantages, and limitations of these
approaches within the broader quality control (QC) framework. Beyond method
selection, the critical role of residual protein analysis in assessing stem cell
functionality, immunogenicity, and long-term therapeutic viability is explored.
Conclusively, by integrating targeted analytical strategies into standard workflows,
manufacturers can improve process reproducibility, enhance product safety, and meet
evolving regulatory expectations for cell-based therapies. This talk provides a researchdriven
and practical outlook on the evolving landscape of quality assurance (QA) in
regenerative and restorative medicine applications, emphasizing the need for
comprehensive analytical frameworks to support the widespread clinical adoption of
cellular therapeutics.