CD Laboratory for Innovative Tools for Biosimilar Characterization

Biopharmaceuticals are drugs that are produced by living organisms. As these are complex proteins, it is very time-consuming to prove sufficient similarity to the original for copycat preparations.

For biopharmaceuticals, living microorganisms or cell cultures are made to produce drugs using biotechnological methods - the oldest example is human insulin. Biosimilars are versions of these drugs that are derived from existing products after their patent protection has expired. Unlike generics, however, a completely exact copy is not possible in the case of biopharmaceuticals - the proteins and their synthesis processes in living cells are too complex. There are many possibilities for deviations, for example in the protein sequence, in the three-dimensional structure and folding, in the aggregation behaviour or in the chemical groups bound to the protein (glycolisation, acetylation).

For a biosimilar to be authorised, it must be shown that it is sufficiently similar to the original product to guarantee the efficacy and safety of the biosimilar. It is therefore not only a matter of comprehensively characterising the originals and the biosimilars biologically and physicochemically, a comprehensive picture is also needed of how similarity and dissimilarity affect the biological position.

To this end, this laboratory analyses well-defined pairs of biosimilars and originator proteins: To what extent do properties such as three-dimensional structure or folding correlate with biological activity? How can the degree of similarity be determined as accurately as possible?

The aim is to gain a better understanding of those parameters that are relevant to the safety and efficacy of biosimilars.

The analytical methods used to characterise the proteins are diverse and include certain methods of liquid chromatography and electrophoresis (HPLC and HPCE), various forms of mass spectrometry, crystallography, chemical synthesis and biological in vitro tests to derive structure-function relationships.