Biologics
Biological drugs include a wide range of drug modalities, such as peptides, monoclonal antibodies, proteins, and oligonucleotides, which require tailored experimental protocols and analytical techniques for their successful ADME-Tox and in vivo DMPK characterization. Besides investigating ADME/DMPK properties, structural characterization is an essential part of the development process of larger biologics, such as mAbs and ADCs. Liquid chromatography – mass spectrometry (LC/MS) based techniques are excellent for this, providing unambiguous structural and quantitative information. Use of state-of-the-art analytical instrumentation and software allows straightforward sample analysis and delivers reliable high-quality results. In addition, enzyme-linked immunosorbent-assays (ELISA) are an efficient and convenient way to quantify proteins, when the needed antibody is available.