Quality Control of Personalized Drug Products - Identity and Quantity of Monoclonal Antibodies as Active Pharmaceutical Ingredient.

This study focuses on quality control of personalized drug products - identity and quantity of monoclonal antibodies as active pharmaceutical ingredient.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Deliberate underdosing occurred in personalized preparations of drugs such as monoclonal antibodies as the active pharmaceutical ingredient in the past. To ensure the required quality standard and to prevent future fraud attempts at an early stage, a HPLC-DAD-HRMS method was established. Thereby, identity and quantity of the active ingredients bevacizumab,...

This study focuses on quality control of personalized drug products - identity and quantity of monoclonal antibodies as active pharmaceutical ingredient.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Deliberate underdosing occurred in personalized preparations of drugs such as monoclonal antibodies as the active pharmaceutical ingredient in the past. To ensure the required quality standard and to prevent future fraud attempts at an early stage, a HPLC-DAD-HRMS method was established. Thereby, identity and quantity of the active ingredients bevacizumab,... Research Background and Significance Personalized drug products, especially those incorporating monoclonal antibodies (mAbs) as active pharmaceutical ingredients (APIs), represent a frontier in biopharmaceutical therapeutics. These individualized treatments require stringent quality control to assure both identity and accurate quantification of the mAbs, given their complex protein structures and significant clinical importance. Historically, issues such as deliberate underdosing in personalized mAb preparations have compromised therapeutic efficacy and patient safety. This has underscored the necessity for robust analytical methodologies capable of sensitive, precise, and reliable characterization of these biologics. High-performance liquid chromatography (HPLC) coupled with diode array detection (DAD) and high-resolution mass spectrometry (HRMS) offers a powerful platform to address these challenges by combining excellent separation capabilities with molecular specificity. The study by Reinders et al. (2023) exemplifies the integration of these techniques to establish a validated workflow tailored for the quality control