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ingredient. Research-grade pDNA is an alternative
option, but the methods to produce it are not
validated, resulting in varying product quality
from batch to batch as well as the potential
risk of cross contamination due to less rigid
cleaning requirements in research laboratories.
Modular facilities, such as the Cytiva KUBio™
modular environments, which are capable of
rapidly deploying GMP-level manufacturing
capabilities, are one solution to overcome the
shortage in pDNA supply and address the unique
needs of mRNA across its entire workflow. These
predesigned, prefabricated manufacturing
platforms offer a quicker route to operational
availability as well as rapid product changeover
and reduced cleaning requirements through
the use of single-use technology (SUT). As
opposed to constructing a dedicated greenfield
production facility for the mRNA workflow that
would likely take years to build, a new modular
facility can be up and running in about 12
months. Akron Biotech recently announced its
use of Cytiva's FlexFactory™ single-use platform
for the manufacture of pDNA, which it sees as
an opportunity to support innovative therapies
with scalable solutions.8 Utilizing FlexFactory ™
Figurate™ automation and connectivity, Akron
Biotech is able to maintain GMP compliance
using a fully validated manufacturing platform
that facilitates regulatory filings. This is critical
in an evolving area of the industry where both
manufacturers and regulatory authorities are
continuing to learn and grow. By eliminating
the burden of legacy facilities and embracing a
digitized, standardized solution, Akron Biotech
is able to position themselves for a place
in a growing field of novel therapeutics.
Encapsulating mRNA For Potent Delivery
One of the biggest technical challenges in
developing mRNA therapies is encapsulation
using specialized lipid nanoparticles, which both
protect the mRNA and enable delivery to the
targeted cell cytoplasm. Conventional methods
for encapsulation present considerable challenges
for maintaining the efficiency of mRNA
manufacturing, such as limited control over
particle size; significant batch-to-batch variability;
substantial material loss from low encapsulation
efficiency; and a labor-intensive production
process that is difficult to scale up.9 Outside
of manufacturing, encapsulation is critical for
establishing the potency of the mRNA drug by
providing appropriate targeting and release.
Consistency in particle size requires a technology
that ensures robust and reproducible
lipid nanoparticle production that can control
how the environment and concentration of
RNA and lipids come together to form the
final particle. Microfluidics, a standard tool in
development settings, offers this control by
using non-turbulent, time-invariant mixing
conditions to create highly reproducible
mRNA lipid nanoparticles. Microfluidics
technology offers encapsulation efficiency
of >90% throughout manufacturing.10 Using | 13


Table of Contents for the Digital Edition of Cytiva_Jan2022_mRNAVaccinesANewEra

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