Claire I. Butré

New gene therapy modalities, such as CRISPR guide RNA (single guide ribonucleic acid [sgRNA]) and messenger RNA (mRNA), continue to make progress in both primate and first-in-human trials. As this progress builds, the industry remains accountable for characterizing these molecules to meet the requirements of regulatory authorities.

A novel method to simultaneously characterize the capping and poly(A) tail for therapeutic mRNA in a single sample preparation workflow is described.

The methodologies demonstrated here open the way to fully compliant at-line monitoring of monoclonal antibody quality attributes.

The methodologies demonstrated here open the way to fully compliant at-line monitoring of monoclonal antibody quality attributes.