An innovative standard for LC ‐MS‐based HCP profiling and accurate quantity assessment: Application to batch consistency in viral vaccine samples

In this study, we developed an innovat ive standard dedicated to MS‐based HCP profiling analysis in order to monitor the consistency of viral vaccine intermediate purification samples. This standard, termed the HCP‐PROFILER standard, is composed of a water‐soluble bead (READYBEADS technology) which, after being added into the sampl e, releases unlabeled peptides in controlled amounts. The standard meets three desired criteria: (1) it is composed of multiple peptides, at different concentration levels, allowing construction of a calibration curve covering the dynamic range of HCPs present in the target sample, ensuring quantifi cation accuracy; (2) it demonstrates high batch‐to‐batch reproducibility, ensuring quantification robustness and consistency over time; and (3) it is easy to use and avoids user‐induced analytical biases. In this study, we present the use of the HCP‐PROFILER standard for vaccine batches comp arison and downstream process performance studies.

Source: Proteomics - March 9, 2021 Category: Biochemistry Authors: Mathieu Trauchessec, Anne Marie Hesse, Alexandra Kraut, Yves Berard, Laura Herment, Tanguy Fortin, Christophe Bruley, Myriam Ferro, Catherine Manin Tags: RESEARCH ARTICLE Source Type: research