GEN-Thermo_Oct22_MakingThePromiseOf - 19

OVERCOMING mRNA PRODUCTION SCALE-UP CHALLENGES
Advice from Our Technical Team:
Pirkko Muhonen
Senior Field Applications Scientist,
Thermo Fisher Scientific
Provides scientific support for
customers developing and
scaling their mRNA produtction
capacities
Vaida Šeputienė
Product Development Manager,
Thermo Fisher Scientific
Develops and optimizes mRNA
synthesis and modification
protocols
Sirat Sikka
Field Applications Scientist,
Thermo Fisher Scientific
Provides guidance on experimental
design and optimization
of IVT to maximize yield and
obtain highest-quality product
Monika Gasiūnienė
Senior Product Development
Scientist, Thermo Fisher Scientific
Develops and optimizes mRNA
synthesis at small and large scales
as well as developing recommendations
for scaling up IVT reactions
Question 1: What are the top challenges?
" This is a recent technology, so it's important to
know when and how to change to larger vessels,
and how to select and operate the bioreactor
vessels for linear scale-up. Downstream processes
can also look different when scaling up, including
filtration, buffer exchange, and purification steps.
The number and volumes of different buffers
required through the large-scale manufacturing
and purification is higher than used in microliter-scale
IVT reactions, which can add complexity
to your development. " -Pirkko
" Optimization of the IVT reaction to ensure yield
and good quality while minimizing side products
such as dsRNA is a big challenge, as is ensuring any
system for purifying your mRNA product is easy,
scalable, cost-efficient-and comes with a robust
analytical method. " -Vaida
" IVT at scale requires large amounts of DNA-
but lead times can be long and thus can delay
your development and production programs. In
production, careful handling of large volumes of
raw materials or RNA product can be tricky-but
is a must to avoid RNase contamination, which will
affect product quality. " -Sirat
" The first thing that is important to consider is if the
yield is increasing linearly when scaling up the IVT
reaction. " -Monika
GENengnews.com | 19
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GEN-Thermo_Oct22_MakingThePromiseOf

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