Understanding the discrimination and quantification of monoclonal antibodies preparations using Raman spectroscopy

The use of Raman spectroscopy for analytical quality control anticancer drug preparations in clinical pharmaceutical dispensing units is increasing popularity, notably supported by commercially available, purpose designed instruments. Although not legislatively compulsory, methods are frequently used post-preparation to verify the accuracy a preparation terms identity and quantity solution. However, while rapid, cost effective label free analysis achieved with appealing, it important understand molecular origin spectral contributions collected from solution actives excipients, evaluate strength limitation technique, which can be identify quantify either prescribed commercial formulation, and/or active itself, personalised solutions. In current study, four formulations, Erbitux®, Truxima®, Ontruzant® Avastin® monoclonal antibodies (mAbs), corresponding respectively cetuximab, rituximab, trastuzumab bevacizumab have been highlight key role excipients discrimination quantification formulations. It demonstrated that protein based drugs such as mAbs relatively weak response, glycine, trehalose or histidine contribute significantly spectra. Multivariate (partial least square regression partial discriminant analysis) further demonstrates signatures themselves prominent mathematical models those solely responsible differentiation formulation accurate determination concentrations. While successfully validate conformity intravenous infusion solutions, basis should considered, special caution given excipient compositions formulations ensure reliability reproducibility analysis.