Oxidation and reduction analysis of therapeutic recombinant human interleukin-15 by HPLC and LC-MS.

This study investigates oxidation and reduction analysis of therapeutic recombinant human interleukin-15 by hplc and lc-ms.. The research utilizes high-performance liquid chromatography (HPLC) as the primary analytical technique to address specific challenges in pharmaceutical analysis. Being an important immune stimulant of T lymphocytes and NK cells, the recombinant human interleukin-15 (rhIL-15) has been extensively researched in tumor immunotherapy or as a vaccine adjuvant. However, the rhIL-15 manufacturing level lags far behind its growing clinical demand due to the lack of efficient and exact analysis methodologies... Research Background and Significance Recombinant human interleukin-15 (rhIL-15) is a critical cytokine involved in the activation and proliferation of T lymphocytes and natural killer (NK) cells, positioning it as a promising agent in tumor immunotherapy and vaccine adjuvant development. Despite its therapeutic potential, the manufacturing and quality control of rhIL-15 face significant challenges, largely due to the protein’s susceptibility to oxidative and reductive modifications. These post-translational modifications can adversely affect the biological activity, stability, and safety profile of rhIL-15. Therefore, accurate, sensitive, and reliable analytical methods are essential for characterizing these chemical alterations during production and storage. High-performance liquid chromatography (HPLC) combined with liquid chromatography-mass spectrometry (LC-MS) represents a powerful analytical platform to separate, detect, and characterize oxidation and reduction variants in biopharmaceuticals. This study addresses the critical need for validated methodologies capable of monitoring the oxidative and reductive states of rhIL-15, contributing to i