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Poster Presentations
Day 2, June 23（Mon.）
Room P (Maesato East, Foyer, Ocean Wing)
- 2P-PM-35
Optimization of a new peak detection function and comparison for selecting a fit-for-purpose multi-attribute method system.
(KKC)
oEriko Numao, Kumi Yanagisawa, Yuki Yagi, Daisuke Tsuchida, Katsuyoshi Yamazaki
The multi-attribute method (MAM) has been recognized as an optimal tool for quality control in biotherapeutics. New peak detection (NPD) is one of the functions of MAM for detecting unexpected differences in samples and is an essential feature required for replacing conventional methods with MAM. Not only used for release and stability testing, NPD is also considered valuable for evaluating comparability and identifying product quality attributes in the research phase.
Although many researchers consider the processing parameter the key to NPD, the details of the decision-making process are unclear. This research aimed to confirm the applicability of our original decision-making approach for NPD processing parameters using two different systems.
After optimization for each, under a condition that detected crucial differences and did not return false positives, they differed in the reproducibility of the results. The eligibility of processing methods was evaluated in light of the equivalency of conventional methods' detectability, and the NPD results of different systems was compared. The findings suggested that the capability of NPD is determined not only by the instrument's resolution but also by the software's capability. Our approach for optimizing the NPD processing parameter is deemed widely applicable in developing therapeutic proteins.