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Increasing mRNA Capabilities And Capacity for Growing Market Needs
technologies, such as Precision Nanosystems'
NxGen™ platform, microfluidics is now available
at manufacturing scales. Next, tangential flow
filtration is used to remove the ethanol as well
as any unwanted solvents and then replace
them with the desired buffer for storage. Finally,
any bioburden that is in the bulk mRNA lipid
nanoparticle formulation is removed through
sterile filtration, ensuring sterility and preserving
the inherently unstable mRNA molecule.
Protecting the mRNA molecule in the final stages
of production will also drive storage stability,
another challenge in the mRNA workflow.
Ultra-cold chain requirements for mRNA have
made widespread distribution of the Moderna
and Pfizer-BioNTech COVID-19 vaccines difficult
and costly. An ultracold storage box for the
-20 C and -70 C temperature requirements,
respectively, typically cost between $10,000
and $20,000.11 Recent readiness assessments for
COVID-19 vaccine distribution found that only
about 50% of countries assessed had the cold
chain capacities necessary to deploy them.12
Another way to protect mRNA stability is by
reducing the risk of microbial contamination
during fill finish using advanced technologies
that eliminate human intervention, such as
robotic aseptic filling systems utilizing SUT.
Traditional filling machines require downtime for
cleaning and sterilization, which is not feasible
for small batch processing, where flexibility
and speed are key. For example, the science
of mRNA allows a company to target multiple
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development candidates just by changing the
payload of the RNA within the lipid nanoparticle
to deliver a different outcome or treat a
different indication. Standardized robotic filling
systems that rely on presterilized, disposable
components within a closed system, such as
the Cytiva Microcell vial filler, facilitate faster
product changeover and enable improved
process control by limiting exposure to any
external forms of contamination, regardless of
the processes and formulation used upstream.11
This means you can quickly produce your full
product portfolio in any dosage presentation
as needed, driving clinical candidates forward
faster and ultimately improving speed to market.
There is also a reduction in startup time, with
robotic filling systems requiring only six months
to one year for installation as opposed to the 18
to 24 months needed for conventional systems.
mRNA Readiness From Idea To Injection
While the need to move quickly to slow the
pandemic required utilization of traditional
and less efficient processes and technologies,
a limitless future for mRNA means exploring
new and innovative solutions that can open the
door for improvement in many areas. Progress
is being made across the entire workflow,
with an increased focus on securing starting
materials, optimizing large-scale manufacturing
platforms, and improving technical skills for
mRNA process development and manufacturing.
As you consider your strategy and the


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