Specificity of bioanalytical methods for pharmacokinetic support of biological macromolecular therapeutics is important.

摘要

Macromolecular compounds, including endogenous proteins, monoclonal antibodies and antibody-drug conjugates, and oligonucleotides such as Toll-like receptor agonists, aptamers, antisense agents and molecules designed to block RNA transmission of the protein-building message (siRNA), constitute an increasing number of agents in development as potential therapeutics for humans. Pharmaceutical Research and Manufacturers (PhRMA), the US industry association, reported in 2008 that 633 biotechnology agents were in development for 100 different diseases [1]. In this editorial, the term 'biologic' is taken to include all of the above-mentioned classes of molecules, although oligonucleotides and shorter peptides are typically produced by chemical synthesis rather than by cell-based systems. Given their diverse mechanisms of action, these varied molecules offer many exciting potential therapeutic opportunities across a wide range of disease indications.