3. Analysis of therapeutic proteins by RPLC

3.1 Characterization of therapeutic proteins

In the pharmaceutical field, molecules derived from biological sources are increasingly replacing small molecules (molar mass < 500 g/mol) derived from synthetic chemistry and traditionally used as drugs. These pharmaceutical biotechnology products are also known as "biopharmaceuticals", and include recombinant proteins in particular.

Therapeutic proteins are difficult to characterize, as the authorities require a large number of verifications (primary sequence, post-translational modifications, aggregation characterization...) which often need to be confirmed by two orthogonal analytical methods. In addition, proteins intrinsically suffer from a problem of micro-heterogeneity that arises during their manufacture,...