[Reliable real-time analytical control of monoclonal antibodies chemotherapies preparations on Multispec automaton]

The aim of our study was the implementation of a systematic control for preparations based upon monoclonal antibodies. Multispec automaton combines ultraviolet (UV) with infrared spectroscopy. Validation of the analytical method was carried out, in terms of qualitative results (with a correct recognition) and quantitative ones. Our first tests tend to show that Multispec automaton is not reliable enough to manage every antibody currently sold on the French market because of a weak correct recognition percentage (around 35 %). When taking into consideration only its own spectra, the improvement is low (50 % recognition). Only a new spectral library with restricted zones in the infrared domain and furthermore with another correlation calculation mode will be able to produce fast and reliable results. In our final library, spectral recognition is correct for 100 % of samples. Quantification achieved thanks to UV is correct in terms of exactness and precision, respectively 6.0 and 8.1 %. To date, we have settled this routine control for every monoclonal antibody available in our institution used in chemotherapies regimens (alemtuzumab, bevacizumab, cetuximab, gemtuzumab ozogamycin, panitumumab, rituximab and trastuzumab). The reliability of our antibody-specific library was demonstrated, likewise the original library for classical chemotherapies.