Beyond Vaccines: Scaling the Promise of RNA Therapeutics - GEN

RNA therapeutics have evolved beyond the world of vaccines, bringing challenges for safe, efficient and scalable RNA therapeutics. Mike May, Ph.D., an author at Genetic Engineering & Biotechnology News (GEN), spoke with representatives of four industry leaders, including NEB, on how they’re advancing the field and meeting demands.

Scaling up and scaling out

Nicole Nichols, Ph.D., NEB Executive Director of Applications and Product Development, noted that NEB is scaling out into smaller, more customized production in addition to scaling up. RNA therapeutic design will likely depend on the therapeutic’s nature, from protein-replacement to genome-editing therapies.

Limitations to RNA therapeutics scalability

There are currently two major limitations to scalability: template generation and the mRNA capping process. Template generation is traditionally dependent on slow, resource-intensive plasmid-based methods, but alternatives based on PCR and isothermal amplification can provide flexibility and speed. Cell-free template generation is a high-fidelity, rapid option as well.

NEB’s GMP-grade Q5 Hot Start High-Fidelity DNA Polymerase offers high-fidelity template amplification and minimizes mutation risk.

mRNA capping methods impact translation efficiency and RNA stability. NEB developed a fusion enzyme to enable co-transcriptional enzymatic capping with low-cost reagents. This also simplifies workflows and enhances yields.


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