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Key Insights Into Overcoming mRNA Process Challenges
As such it lead the work stream to develop
scalable manufacturing solutions for Imperial
College London's saRNA (an mRNA type) vaccine
candidate and was awarded £5 million early in
2021 to support the development of a COVID-19
variant mRNA vaccine library in the U.K.4,5 " Prior
to the pandemic, CPI was studying lipid nanoparticles
and also working with other companies
The implications of what
mRNA could achieve for
modern medicine are far
reaching; yet, advancing
its capabilities means
establishing a development
toolbox that is fit for
purpose, rather than relying
on legacy methods.
and organizations to develop cell-free expression
platforms, which prepositioned us for what we're
doing now, " says Dr. John Liddell, chief technologist
at CPI. " The attraction of mRNA as a vaccine is
that it's highly potent, and you can generate a lot
of vaccine product from small volumes without
requiring a large manufacturing footprint. It also
offers a high transcription yield and reaction
through enzymatic synthesis, allowing you to
18 | GENengnews.com
achieve four or five grams per liter within a few
hours. These advantages mean that a company
with access to the necessary capabilities and
raw materials to produce a new mRNA vaccine
could do so in a matter of weeks, while other
approaches will take significantly longer. "
Overall, the characteristics of mRNA
make it ideal for rapid response to infectious
disease as well as for precision, i.e.,
personalized, medicine, a growing focus
in a changing biopharma landscape-but
only if the industry can overcome existing
mRNA process development challenges.
Where Do We Go From Here?
The implications of what mRNA could achieve for
modern medicine are far reaching; yet, advancing
its capabilities means establishing a development
toolbox that is fit for purpose, rather than relying
on legacy methods designed for monoclonal
antibodies (mAb) or other gene therapies. And
while some aspects of mRNA seem simplified,
the reality is that, technically, everything is new.
" Compared to protein products, RNA is far more
sensitive to degradation - by several orders of
magnitude. It is very prone to RNase [ribonuclease]
degradation, " explains Dr. Liddell. " RNase
activity is ubiquitous and will destroy all of your
products before you even know they've been
destroyed. Therefore, we have to eliminate RNase
activity during development and manufacture
of mRNA-based products, which is very different
from working with proteins. mRNA has the
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Cytiva_Jan2022_mRNAVaccinesANewEra

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