Cytiva_Jan2022_mRNAVaccinesANewEra - 11

mRNA VACCINES: A NEW ERA OF BIOTHERAPEUTIC DEVELOPMENT
Fast forward to late 2020, when the urgency
to stop the spread of coronavirus led to the
groundbreaking EUAs for the Moderna and
Pfizer-BioNTech COVID-19 vaccines. Now, the
success of the mRNA vaccine market-recently
projected to reach $1273 billion by 20273-is
fueling high demand for mRNA, which has
resulted in a critical need to address mRNA
manufacturing bottlenecks. Innovation and
expertise in multiple areas of the industry are
available to address these issues, clearing a path
for the rise of mRNA therapeutics to treat other
indications as well. As manufacturers across
the industry continue to pursue mRNA-based
therapies, it is important they understand the
challenges they may face in their journey and
what solutions could help overcome them.
An mRNA Bottleneck: Yesterday's Facilities
Cannot Manufacture Tomorrow's Products
As the industry raced to answer the call for a
COVID-19 vaccine, it seemed, at least to those
unfamiliar with mRNA, that the clinical success
and expedited production of the Moderna
and Pfizer-BioNTech vaccines were nothing
short of a marvel of modern medicine. Public
perception was that vaccines cannot be
made in a matter of months, or even years, of
development and clinical testing before they
can be safely manufactured to meet largescale
demand. And considering the lengthy
timeframes it took for the medical community
to respond to infectious diseases in the past,
such as smallpox and influenza,4 even industry
experts were skeptical in the early stages of the
pandemic about whether vaccine manufacturers
could produce an approved vaccine quickly
enough to change the course of the COVID-19
outbreak. And under typical circumstances,
their concerns would've been justified.
Traditional viral vector production, where animal
cell culture infected with a weakened virus is
grown in chicken eggs or a fermenter, can take
four to six weeks to achieve adequate biomass
to begin manufacturing, with an additional week
needed for growth and production.5 However,
this months-long process can be reduced to
just minutes with mRNA, due to its reliance
on an in vitro cell-free transcription reaction.
Eliminating the reliance on live-attenuated or
viral-vectored vaccines during development
and manufacturing offers several advantages
to safety, speed, cost, and efficacy. Reaping the
benefits, though, is possible only with access to
critical raw materials and flexible facilities armed
with specialized equipment and expertise.
For Moderna, which had never produced or sold
a commercial drug prior to receiving the EUA
for its COVID vaccine, this meant relying on a
web of outsourcing partners to scale up production.6
This approach is inherently risky and can
reduce speed to market if there isn't seamless
coordination among all partners. And in the end,
Moderna is ultimately responsible for ensuring its
vaccine is made in compliance with regulatory
requirements, which can be challenging when
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