Cytiva_Jan2022_mRNAVaccinesANewEra - 8

Changing the Status Quo of Vaccine Production
vaccine production, is inherently inflexible
and difficult to pivot quickly in pandemic
responses.6 This model presents single points
of failure in the supply chain that are vulnerable
to materials and personnel shortages, export
bottlenecks, and complex cold chain logistics.
All impact production and distribution, resulting
in incomplete geographical coverage.
Techno-economic assessments suggest that
the facility footprint required to produce
RNA vaccines could be two to three orders of
magnitude smaller than conventional vaccine
production processes with 1/20th to 1/35th the
upfront capital investment.5 This could make
a geographically distributed, decentralized
manufacturing model more feasible. Moreover,
integrated manufacturing designs where RNA
drug substance production, LNP formulation,
analytical testing, and fill/finish operations
are localized in a single facility aligns with the
desire of many countries to establish their own
domestic vaccine manufacturing capabilities.
In the face of current COVID-19 vaccine
shortages, localized manufacturing can support
national vaccine requirements as well as offer the
capability to handle emerging regional variants.
Additionally, the modular, disease-agnostic
nature of RNA-LNP means integrated manufacturing
facilities could be used to produce
a number of RNA therapeutics where shared
resources (such as equipment and personnel)
and costs could make decentralized facilities
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more economical. The availability of modularized
GMP production suites and advances in
bioproduction technologies like microfluidics,
digital or " 4.0 " automated bioprocess capabilities,
and inclusion of single-use equipment,
constitute key components to build out such
manufacturing designs. As well, once production
processes are established and validated,
the technology could be adopted by other
facilities to form a network of manufacturing
sites with harmonized processes to grow the
global vaccine production capabilities.5
A report by the World Economic Forum lists the
establishment of a consortium of biofoundries
to foster accelerated development and largescale
vaccine production as a critical element to
combating pandemics.7 The concept of foundries
has revolutionized manufacturing in other industrial
sectors (such as the semiconductor sector)
and is a logical path forward for RNA vaccine
production. Support for this is evidenced by
initiatives such as R3 (a $60 million project jointly
funded by CEPI and Wellcome Leap), which
aims to establish a global network of biofoundries
to democratize access to state-of-the-art
manufacturing centers that will accelerate the
pace and diversity of RNA biologics.8 This could
open up a new era of biomanufacturing with
the agility to pivot rapidly for the emergency
capacity needed for rapid pandemic responses.
Of course, continued collaboration and communication
among all stakeholders from researchers,
developers, manufacturers, and regulatory
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Cytiva_Jan2022_mRNAVaccinesANewEra

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