mRNA Manufacturing: Overcoming CMC Development Challenges

By Linda Mathiasson, Strategic Customer Lead, Nucleic Acid Therapeutics, and Katarina Stenklo, Enterprise Solutions Commercial Activation Leader, Cytiva

As we move toward a future where the mRNA toolbox will likely play a vital role in patient care, there are several areas of consideration where biopharma must focus to minimize bottlenecks and drive fast and efficient mRNA manufacturing. For example, the mRNA molecule and the impurity profile can differ from product to product, calling on different purification strategies to ensure the removal of impurities downstream while preserving the mRNA molecule. Many of today’s resins and membranes have low capacity for large mRNA molecules and poor resolution for impurities, due to their similarity from the target product. This means the biomanufacturing industry will need to develop improved solutions that can accommodate downstream purification of mRNA.

Download the complete article to learn more about what other CMC development challenges you should expect in the mRNA workflow and what experts in this space believe can help overcome them.