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Increasing mRNA Capabilities And Capacity for Growing Market Needs
production doesn't occur in-house. Even Pfizer
ran into complications when working with
BioNTech to manufacture its vaccine, as they
faced a supply shortage of key raw materials
and starting components.7 Therefore, if you're
interested in or already pursuing mRNA-based
therapies and vaccines, you cannot rely on traditional,
often rigid, manufacturing platforms and
filling operations for the production of mRNA.
Outside of manufacturing,
lipid nanoparticle
encapsulation is critical for
establishing the potency
of the mRNA drug by
providing appropriate
targeting and release.
Instead, you must work with solutions that are
designed to support the unique characteristics
and manufacturing needs of the mRNA workflow.
To understand why this is important, consider
the most critical areas of the mRNA workflow
and why flexibility is necessary for success.
Using Flexibility To Navigate The
Complex Workflow For mRNA
Batch size for mRNA is one of the crucial considerations
and can vary based on a company's
12 |
strategy, the therapeutic type, and target patient
population. For example, current mRNA vaccines
are generated in large batches and then filled
in single units, whereas mRNA-based personalized
therapies are produced in a large number
of smaller batches. It is essential to establish a
flexible platform, such as the Cytiva FlexFactoryâ„¢
single-use platform, that can adapt to scale
and product modality with minimal downtime.
Independent of scale, the mRNA manufacturing
site design is unique. Each phase of the
complex workflow requires separate suites for
production of various key starting materials and
components as well as the careful completion
of critical process steps. Since mRNA is a cell-free
process, it is incredibly challenging to manufacture
in facilities where traditional mammalian
cell culture systems are in operation and may
present contamination risks. Alternatively, if you
do not have the ability or capacity to execute the
mRNA workflow in-house, you can work with an
outsourcing partner. Yet, given the rising demand
for mRNA manufacturing capabilities, you will
likely need to get in line with your competitors.
For example, plasmid DNA (pDNA), which
provides the DNA template for gene expression
during the cell-free process of in vitro transcription
(IVT), is an essential building block to
produce the viral vectors needed for cell and
gene therapies. With both markets on the rise,
demands for production of high quality pDNA
are increasing, and the industry is facing limited
availability with long lead times for this crucial


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