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Key Insights Into Overcoming mRNA Process Challenges
acid from degradation as the drug makes
its way through the patient's body. Prior to
encapsulation, the lipids must all first be
dissolved in an organic solvent, which is
typically ethanol. Because ethanol is highly
flammable, facilities must be properly equipped
to ensure safe use of those types of materials,
such as using flame-proof equipment.
If a company does not have these capabilities
in-house, they may look to an outsourcing
partner for encapsulation services; however, this
could be challenging due to the limited number
of CDMOs with experience in this area. There
is also a significant number of patents in this
area, leading to a complex intellectual property
landscape. Dr. Liddell says the lipids used for
mRNA today were originally developed to deliver
small interfering RNA (siRNA) therapies. There
may be better LNP formulations or alternative
delivery technologies that might improve
conditions required for storage stability, which
is another challenge for mRNA products.
Due to the sensitivity of mRNA, an ultracold
chain is necessary to deliver COVID-19
vaccines across the world. Paving a way toward
a future with mRNA by addressing limitations
during process development, though,
could help minimize mRNA's temperature
requirements. " The low temperature needed
to stabilize mRNA comes from the rough
edges arising from rapid development and
22 |
deployment, " explains Dr. Liddell. " We had
to move very quickly for COVID, so people
used what was available, but I really think
there's ample scope for improvement by
selecting appropriate additives and excipients
to achieve storage stability at higher
temperatures. In addition to alternate lipid
and excipient formulations, we may be able
to utilize other formulation technologies, such
as lyophilization to achieve better stability. "
The Future Of mRNA Beyond COVID
While the COVID-19 pandemic took so much
from us-most importantly, over 3.8 million
lives globally7-the white knight of mRNA that
offers eligible vaccine recipients with invaluable
protection will likely open the door to new
opportunities to improve patient care; however,
gaps in knowledge could slow progress in not
only development but also regulatory approval.
Both Drs. Liddell and Zhu agree that we will
likely see continued focus on using mRNA
for vaccines, such as replacing the egg-based
production methods for vaccines, and even
oncology applications, but we must address
these process development issues and more
to make the possibilities of mRNA a reality.
Wherever the industry does go from here,
though, is possible only through collaboration,
communication, and a concerted effort to
pave the way for the exciting future of mRNA.
Click here to learn more about equipment and
solutions for efficient mRNA production. n


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