mRNA/saRNA Manufacturing RNA Analytics & Testing

Aldevron Chief Scientific Officer, Venkata Indurthi, Ph.D., shared his knowledge and experience with manufacturing RNA in a webinar entitled, “mRNA/saRNA Manufacturing – Considerations to Accelerate the Path to Clinic.” As a follow up, Dr. Indurthi sat down with Communications Sr. Director, Ellen Shafer, for an interview to answer dozens of questions he received during the presentation.

Dr. Indurthi discusses key considerations for RNA analytics and testing and how to strategize for reduced pressure on your downstream processes. While RNA was always relevant and valued as a modality, the COVID-19 pandemic served as a catalyst and accelerated the field by 10-to-15 years. It is crucial to understand and define the parameters of molecular design and behavior for your unique therapy product, a process which entails putting the molecule through the standard purification process to get the least amount of impurity and the highest amount of activity of the RNA.

The RNA process introduces certain errors, depending on which polymerase is used and the reaction conditions, making characterization essential to understand how to further optimize your therapy product. A construct or a product specific characterization, if not a full-blown validation, is necessary to understand if the purity that you’re measuring is accurate. Learn more about messenger RNA (mRNA) and self-amplifying RNA (saRNA) development and manufacturing processes and how different projects' needs may vary.