Application note June 10th, 2019

Residual protein taxonomy identification in cell & gene therapies

Most of the Cell and Gene therapies processes involve several taxonomies such as human, bovine and even sometimes bacteria (E Coli) to express the protein or RNA of interest. However, the presence of remaining proteins, after production, from other than human taxonomy could be a problem for the efficacy of the treatment or even for the safety of the patient.

To be able to differentiate proteins from different taxonomies, analytical methods with high specificity are mandatory. In such application, thanks to its specific detection, LC-MS can differentiate proteins coming from different taxonomies as soon as detected proteins have specific sequences.

In this case study, one specific sample where human cells have been mixed with E.Coli and Bovine proteins has been analysed. The figure presents the pie charts for the 59 detected proteins and their related taxonomies. On the right-hand side, the pie chart shows that the 45 human protein represents 90% of the total amount of protein while the 12 proteins bovine and the 2 proteins from E.Coli ones represent respectively 9 and 1%.

These data are very useful to