Analytical Services for Cell & Gene Therapy
Gene therapy is a novel therapeutic approach aimed at correcting or reconstructing defective genetic material to achieve long-term high therapeutic effects. This therapeutic approach has tremendous potential to treat diseases that currently lack effective treatments. Among the most promising platforms for in vivo gene transfer are viral vectors (VV) and oncolytic viruses (OV), which are being extensively studied as highly effective therapeutic agents. However, due to their complex structures and mechanisms, the critical quality attributes (CQAs) for VV and OV are different from those of conventional biopharmaceuticals. Developing and ensuring the quality of VV and OV requires a high level of expertise with biophysical analysis.

Overview of gene therapy

As experts in this field, we have been offering quality analysis services of VV using biophysical analysis. To further advance our capabilities, we established a new unit “cell and gene therapy unit” in April 2022, extending our services to both domestic and international customers. Our research and development results have been published in academic papers, including a method for accurately quantifying the size distribution full particles/partial particles/empty particles using ultracentrifugation analysis and a method that enables microscopic measurement. Our world-class quality services encompass AUC, mass spectrometry, particle, and aggregate characterization, enabling us to provide top-notch quality control and development services.