- 第3日 6月24日（金） P会場（501，502，503）
In recently years, LC-MS intact mass analysis has become an indispensable utility for the characterization and quantification of biotherapeutics in all stages of their development. It is said analytical solutions that can achieve high throughput (HT) intact mass analysis and impurities profiling are advantageous for complexity biotherapeutics. The developed new software is fully integrated with HT screening LC-MS system as well as impurity assignment and quantification for variety biomolecules of ESI+ or ESI- acquired data. A total of 6 mAbs were used for the HT screening experiments. The optimized HT LC-MS method was found to shorten 48 minutes compared with conventional method for 48-well sample plate from acquisition to processing. PTMs were found to be less than 15ppm. Also, sgRNA is well known as challenging separation due to many situations. However, the software described putatively assigs molecular identities to co-eluting impurities based on their ESI-MS spectra after searching an extensive list of common oligonucleotide modifications. Five impurities were identified and quantified in the 100-mer sgRNA with mass accuracies under 20 ppm. We report the new versatile informatics application tool for biotherapeutics intact mass HT screening and impurity profiling in compliance ready environment.