Development and validation of a method for airborne monoclonal antibodies to quantify workplace exposure.

This study focuses on development and validation of a method for airborne monoclonal antibodies to quantify workplace exposure.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Modern therapy strategies are based on patient-specific treatment where the drug and dose are optimally adapted to the patient's needs. In recent drugs, monoclonal antibodies (mAbs) are increasingly used as active ingredients. Their patient-specific formulations are not part of the pharmaceutical industry's manufacturing process but are prepared from concentrates by...

This study focuses on development and validation of a method for airborne monoclonal antibodies to quantify workplace exposure.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Modern therapy strategies are based on patient-specific treatment where the drug and dose are optimally adapted to the patient's needs. In recent drugs, monoclonal antibodies (mAbs) are increasingly used as active ingredients. Their patient-specific formulations are not part of the pharmaceutical industry's manufacturing process but are prepared from concentrates by... Research Background and Significance The increasing use of monoclonal antibodies (mAbs) as therapeutic agents has revolutionized modern biopharmaceutical treatment strategies. These biologics are often formulated in patient-specific dosages tailored to optimize therapeutic efficacy and minimize adverse effects. However, the unique preparation and handling of these mAbs pose occupational health concerns, particularly regarding airborne exposure in workplace environments. Quantifying airborne monoclonal antibodies is critical to assess potential risks to healthcare workers and manufacturing personnel. Traditional analytical approaches face challenges due to the complex nature of mAbs, which are large, heterogeneous biomolecules requiring sensitive and selective detection methods. This study addresses this gap by developing and validating a high-performance liquid chromatography (HPLC) method tailored for the detection and quantification of airborne monoclonal antibodies, contributing significantly to workplace safety monitoring in biopharmaceutical settings. Experimental Design and Methodology The authors designed a robust analytical workfl