Reducing dsRNA With IVT Processes
- Removing dsRNA impurity from IVT generated mRNA using standard purification methods has been challenging and unsuccessful on large scale mRNA manufacturing platforms
- Developing 2 novel IVT buffer strategies to reduce dsRNA while keeping PQs unaltered with current Pfizer mRNA platform process
- Testing monovalent salt and biodegradable aprotic solvent (BAS) both individually and in combination in IVT buffer to reduce dsRNA generation during transcription
- Our results indicate significant reduction in dsRNA with both strategies individually using multiple constructs at both small scale and qualified small-scale platforms for large scale mRNA manufacturing which are GMP and environmentally friendly while reducing/eliminating the need for expensive and time-consuming purification processes