Identification of monoclonal antibody drug substances using non-destructive Raman spectroscopy.

This study focuses on identification of monoclonal antibody drug substances using non-destructive raman spectroscopy.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Monoclonal antibodies provide highly specific and effective therapies for the treatment of chronic diseases. These protein-based therapeutics, or drug substances, are transported in single used plastic packaging to fill finish sites. According to good manufacturing practice guidelines, each drug substance needs to be identified before manufacturing of the drug product.... Research Background and Significance Monoclonal antibodies (mAbs) have revolutionized therapeutic strategies for a broad spectrum of chronic diseases due to their high specificity and efficacy. Ensuring the identity and purity of these biopharmaceutical drug substances prior to drug product manufacturing is critical to comply with stringent regulatory and good manufacturing practice (GMP) guidelines. Traditionally, identification methods for mAbs have relied on destructive techniques that consume valuable sample and may not always be feasible for in-process controls. This study explores the application of non-destructive Raman spectroscopy as a complementary analytical tool, integrated with high-performance liquid chromatography (HPLC) to enhance the identification and characterization of monoclonal antibody drug substances. The combined approach addresses the analytical challenges inherent to biopharmaceutical substances, such as complexity, heterogeneity, and sensitivity to denaturation, thereby ensuring robust quality control. Experimental Design and Methodology The study employed a validated HPLC method tailored for monoclonal antibody analy