Abstract

During the recent decades considerable efforts have been made to develop
biological drugs and this diverse line of research is expected to continue its
growth. The methods used for investigating the ADME-Tox properties of the
biological drugs are different than those traditionally used for small
molecules. In the preclinical development of
biological drugs, various analytical techniques are
needed and thorough structural characterisation of biological drug candidates
forms an essential part of the development process.

Traditionally the analytical techniques of biological drugs have been
dependent on immunoassays. It is notable that the current LC/MS
systems provide a good selection of tools not only for comprehensive
structural characterisation, but also for quantification of biological drug
candidates and process-related impurities. The clear advantage
of LC/MS assays over immunoassays is that they are not dependent on having an
antibody/antigen for the target. 

Other noteworthy points of characterisation are protein-protein
interactions for example to evaluate the specificity and
binding kinetics. As the neonatal Fc receptor (FcRn) play
a big role in the pharmacokinetics of the Fc-containing
proteins it is recommendable to investigate and optimise the binding of the
compound to this receptor. In addition to evaluating potential immunogenicity
by utilising human originating cell lines, investigation of Fc
gamma receptor (FcƴR)-binding may be used to evaluate antibody dependent
cellular cytotoxicity (ADCC). 

The solutions for obtaining high-quality scientific data to support
preclinical development of biological drugs will be
demonstrated in this poster presentation.