Critical Risks Associated with sgRNA Drug Substances

GeneLancet issues an urgent call for caution concerning the critical risks associated with sgRNA drug substances, highlighting a profound, humanity-level threat in the rapid expansion of in vivo CRISPR gene editing trials that rely on synthetic sgRNA products. Numerous scientific studies have consistently demonstrated that the commonly used full-length product (FLP) purity assessments—based on UV area percentages in high-performance liquid chromatography (HPLC)—dangerously inflate actual purity levels, falsely indicating compliance with regulatory thresholds (>80%). To ensure safety, mass spectrometry (MS) analysis of the primary FLP peak is essential, as these discrepancies can deceive stakeholders about the true degree of impurity management. The public, regulators, and industry leaders must insist on swift reforms to avert potentially disastrous consequences.

Public Advisory:
Critical Risks from Overestimated sgRNA Purity in In Vivo CRISPR Therapies