Assessment of Quality Attributes

Gene therapy is a new treatment method that has drawn attention as a viable solution for diseases that have not had effective treatments established so far. It can be expected to achieve a high therapeutic effect over a long period of time by introducing genes into the body. Virus vectors (VV) and oncolytic viruses (OV) are one of the most promising platforms that allow gene delivery within the body, and research and development have been progressing for their use as highly effective therapeutic agents. However, due to the complexity of their structure and mechanism of action, it has been discovered that the critical quality attributes (CQA) related to efficacy and safety cannot be handled in the same way as conventional biopharmaceuticals. Effective and efficient development and quality management require high expertise and various physicochemical analyses.

At U-medico, we offer analytical services for quality analysis, including ultra-centrifugation analysis and mass spectrometry, for P1, P2, and BSL2. We also provide testing according to reliability.

Quality Attributes
Molar extinction coefficient
Viral genome titer
Full/Empty ratio
Size distribution Full particle
Partial particle
Empty particle
Particle size
Amino acid sequence, post-translational modification, chemical modification

Analysis with some reliability standards is possible. Preparing for GMP compliance. We offer services in P2 and BSL2.