GEN-Thermo_Oct22_MakingThePromiseOf - 5

OVERCOMING mRNA PRODUCTION SCALE-UP CHALLENGES
tion continues, we can expect to see increased
momentum in the development and commercialization
of novel mRNA-based therapies in 2023 and
beyond.
The Road to mRNA Technology
mRNA as the technological basis of vaccines and
therapeutics may appear to be novel, but scientific
research into its development began decades ago. A
key turning point in this journey came when, in the
2005, Dr. Katalin Karikó and her colleague Dr. Drew
Weissman were successful in minimizing the body's
harmful inflammatory immune response to exposure
to a virus's mRNA while still allowing it to stimulate
the immune system [2]-a thorny obstacle in the
path for advancement of mRNA therapies.
Traditionally, vaccines are virus-based, using attenuated
or inactivated versions of the target virus. Some
examples of these virus-based vaccines include the
ProQuad™ vaccine for measles, mumps, rubella, and
varicella; the RotaTeq™ vaccine for rotavirus, Avaxim™
vaccine for hepatitis A, and many flu vaccines
(Fluzone™, FluLaval™, and Fluad™ among others).
mRNA vaccines, on the other hand, use a synthetic
genetic sequence to instruct the cells to recognize a
virus and activate the immune system.
In mRNA vaccine development, researchers begin by
creating a strand of mRNA in a lab. This prompts our
cells to create protein fragments that are based on
the " non-self " characteristics of the virus. When recognized,
the protein fragments trigger a response in the
patient's immune system. With COVID-19 vaccines,
for example, the mRNA causes the patient's cells to
produce the spike protein of the SARS-CoV-2 virus.
When the immune system recognizes the spike as
non-self, it produces antibodies that defend the body
against SARS-CoV-2.
While there are unique challenges associated with
the development and commercialization of both
traditional and mRNA vaccines, there are many
advantages to the use of mRNA technology. " To put
it bluntly, traditional vaccines take a long time to
commercialize. The level of difficulty in both developing
and testing new vaccines remains a high
hurdle for any biotech or pharma company, " said
Natraj Ram, Vice President of Innovation, Bioproduction,
at Thermo Fisher Scientific. As mRNA vaccines
do not use attenuated or inactivated viruses, there
are few, if any, potential safety issues associated with
virus particulates. The purification process is also
easier, and the mRNA approach avoids the lengthy
use of cell cultures and the need for optimization to
achieve the right growth conditions. But the greatest
appeal of the mRNA technology lies in the fact that it
is modular-it can be easily tweaked to encode most
proteins without a significant alteration in its chemical
nature. This is also what makes the future of this
technology so promising.
The Potential of-and
Challenges to-Further Scale
As excitement in the mRNA space continues and
new players rapidly join the industry, there is
keen interest in the methodologies and practices
that enable scaled manufacturing of mRNA products
using in vitro transcription (IVT), the gold
standard for mRNA synthesis. One of the reasons
biotech companies were able to swiftly develop
and distribute COVID-19 mRNA vaccines to the
public was their collaboration and innovation
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GEN-Thermo_Oct22_MakingThePromiseOf

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