Nitrosamine Risk Assessments in Oligonucleotides

Abstract

The European Medicines Agency, the U.S. Food and Drug Administration, and other regulatory agencies expect that all pharmaceutical products be assessed for the potential presence of N-nitrosoamine (nitrosamine) impurities. This white paper addresses general considerations for nitrosamine risk assessments of oligonucleotide products. The authors propose a general risk assessment platform which should facilitate safe, consistent development of new treatments and alignment with regulatory expectations.