mRNA is at an inflection point. To reach its therapeutic potential in chronic, and even rare, disease applications, some biopharmaceutical manufacturing fundamentals must be addressed, including (but certainly not limited to):
- The scale-up challenge, specifically the limitations of chromatography, must be solved to facilitate large volumes of homogenous supply.
- Safety profiles must improve in lockstep with scale-up.
- Immunogenicity must be optimized to specific disease states.
- Raw materials quality and consistency standards must be established and adhered to.
Bioprocess Online Live hosted discussion on approaches to reducing mRNA therapeutic risk in parallel with increasing the scale of its production. We leaned into the expertise of leading technical minds in the space. Now available on-demand thanks to the support of Roche Custom Biotech.