GEN-Thermo_Oct22_MakingThePromiseOf - 14

Scaling Up IVT for mRNA Production
Scaling Up IVT for mRNA Production
The good news is
that measures can be
taken to help ensure
consistency in your
workflow and produce
reproducible, highquality
batches of IVT
mRNA at scale.
Getty Images: luza studios
The success of messenger RNA (mRNA) vaccines in
combatting the global SARS-CoV-2 crisis brings a
new era of vaccine development. mRNA vaccines
and therapeutics elicit strong but transient protein
expression to generate immunity, but with minimal
risk of genome integration, infection, or activation of
an innate immune response that can arise with standard
vaccines. Translation of in vitro transcribed (IVT)
RNA to mRNA therapeutics has exciting implications
for modern medicine, as the ability to easily change
mRNA sequences helps provide a flexible platform to
create robust therapeutics against a wide variety of
chronic and infectious diseases.
Despite the success of mRNA and its spectacular
market growth, the field is still in its infancy and
there are still challenges to address in the production
of mRNA therapeutics. IVT is a complex process,
14 | GENengnews.com
requiring a mixture of RNA polymerase and accessory
components (e.g., RNase inhibitor, inorganic pyrophosphatase),
nucleoside triphosphates (NTPs), and
a DNA template to make each mRNA. There is not a
single solution for optimal RNA yield, as it depends on
a series of reaction variables and is sequence dependent.
A lack of standardization across methodologies
and practices can also make efficient and effective
process development difficult. As RNA manufacturing
operations are fairly new, process development and
scale-up for commercial manufacture can come with
significant bottlenecks, limiting the ability to rapidly
increase production in response to an urgent need.
The good news is that measures can be taken to help
ensure consistency in your workflow and produce
reproducible, high-quality batches of IVT mRNA at
scale.
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GEN-Thermo_Oct22_MakingThePromiseOf

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