Complexing RNPs Is A Straightforward Process. Have You Established Your Clinical Acceptance Criteria?

By Max Sellman, Sr. Product Manager

Are you effectively controlling the RNP (ribonucleoprotein) complex formation step in your gene-modified cell therapy workflow?

When using CRISPR-Cas proteins for gene editing, it’s critical to ensure consistency and quality at each stage of the manufacturing process. The FDA recommends establishing well-defined acceptance criteria for the RNP formation step, as it directly impacts the efficiency, specificity, and safety of genome editing. Robust control at this step supports regulatory compliance, improves reproducibility, and enhances overall product quality in cell therapy manufacturing.