The UTgene Quality Team has extensive experience in IND filing, and meets the requirements of dual filing in China and the United States. We possess comprehensive research capabilities for the quality of DS mRNA, LNP formulations, and ionizable lipid molecules.

In terms of impurity research, the research of mRNA process and product-related impurities is in accordance with ICH, ChP and USP. The purification process capability validation facilitates the process development of mRNA.

In the case of novel ionizable lipids, the quality standards can be established based on their impurity spectrum studies. In the case of LNP, specific impurities can be identified from the process. The team has extensive experience in stability studies, particularly in developing stability study protocols for novel LNP delivery systems to provide a basis for the development of new delivery systems and reduce development risks.

In coordination with LNP process development, we can develop specific in-process control strategy and quality research protocols for intermediates to assist downstream process development and scale-up, thus reducing industrialization difficulties. UTgene has a comprehensive quality testing platform, including HPLC (equipped with UV-Vis, CAD, ELSD detectors), mass spectrometry, laser particle size analyzer, PCR, ELISA, subvisible particle detector, TOC analyzer, as well as environmental monitoring capabilities for clean workshop and microbiological limit/aseptic monitoring platforms. Those can independently provide services to clients. All equipment was validated and regularly calibrated according to quality management documents to ensure the reliability of results.