Comparison of a new peak detection function for selecting a phase-appropriate multi-attribute method system.

Abstract

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. Besides specific instruments and software packages has been used almost exclusively, yet the differences in NPD function between other choices have not been confirmed. Thus, 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. To our knowledge, this was the first time the comparison of NPD results of different systems has been published, and the eligibility of processing methods was evaluated in light of the equivalency of conventional methods' detectability. 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 and practical in developing therapeutic proteins. The revealed difference will help us select the fit-for-purpose system.