HPLC-MS/MS-based quantification of human monoclonal antibodies targeting SARS-CoV-2 in the presence of endogenous SARS-CoV-2 antibodies in human serum.

This study focuses on hplc-ms/ms-based quantification of human monoclonal antibodies targeting sars-cov-2 in the presence of endogenous sars-cov-2 antibodies in human serum.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Antibodies for treatment and prophylaxis against SARS-CoV-2 are needed particularly for immunocompromised individuals, who cannot adequately benefit from vaccination. To address this need, Aerium Therapeutics is developing antibodies targeting the SARS-CoV-2 spike protein. A bioanalytical method to quantify fully human monoclonal antibodies in a population with widely varying anti-spike antibody... Research Background and Significance The COVID-19 pandemic has underscored the critical need for effective therapeutic interventions targeting SARS-CoV-2, especially in immunocompromised populations who do not mount sufficient immune responses to vaccination. Monoclonal antibodies (mAbs) directed against the viral spike protein have emerged as potent tools for both treatment and prophylaxis. However, quantifying these exogenous therapeutic antibodies in human serum presents substantial analytical challenges, primarily due to the presence of endogenous anti-SARS-CoV-2 antibodies generated by prior infection or vaccination. This interference complicates the accurate measurement of administered monoclonal antibodies, which is essential for pharmacokinetic studies, dose optimization, and therapeutic monitoring. In this context, Schäfer et al. (2024) developed an HPLC-MS/MS-based bioanalytical method tailored to selectively quantify fully human monoclonal antibodies targeting SARS-CoV-2 spike protein in serum samples with varying endogenous antibody levels. Their work