Genome editing using clustered regularly interspaced short palindromic repeats (CRISPR) has been used to great effect in vitro to allow scientists to more rapidly investigate molecular pathways that may be involved in disease. The logical progression for the CRISPR machinery is to move from bench to bedside into the world of therapeutics and clinical diagnostics. Depending upon the intended therapeutic use of CRISPR, there are as many bioanalytical challenges in order to resolve scientific questions as drug development and regulatory questions. The aim of this article is to highlight bioanalytical challenges associated with such a powerful therapeutic tool, and strategies that may be required to facilitate the clinical development of CRISPR.
Keywords: CRISPR; bioanalysis; genome editors.