eBook: Formulation Technologies and Strategies for Successful New Product Development - 14

So, all in all, we have a very exciting future ahead of
us, because the way diseases are treated is completely
going to change.
DA: What do you see as the real differentiators in
the services that MilliporeSigma provides under its
SAFC® portfolio brand?
SM: MilliporeSigma has over 24 years of experience
in manufacturing GMP lipids. We have an established
center of excellence and are a very trusted supplier for
many parties. Our excellent track record includes the
successful execution of a large number of projects for
different clients. MilliporeSigma also has a dedicated
contract
manufacturing
organization
with
the
necessary competencies on site that is part of a global
network of facilities for scale-up if needed and that can
serve as secondary manufacturing sites. All of these
facilities are frequently inspected by the FDA, EMA,
other health agencies, and customers.
MilliporeSigma was working with mRNA companies
before the pandemic, and we are very happy to see the
progress being made in the field. The recent acquisition
of AmpTec further expands our presence in the mRNA
field. It also reflects our faith in the technology.
Our lipid team is also highly experienced, with over
85 years combined working in this field. They have
the deep know-how to develop solutions for even the
most challenging customer projects. As an example,
MilliporeSigma rose to the challenge of producing
very large quantities of lipids for BioNTech's vaccine for
COVID-19.1
Our goal is to provide the best support possible to our
customers - both our existing customers and other
companies advancing the mRNA therapeutics and
vaccines and the science behind them. Readers can
learn more about MilliporeSigma's insights regarding
successful formulation development for lipid-based
RNA delivery and vaccines in our recent white paper.2
References
1. Merck KGaA, Darmstadt, Germany, and BioNTech Extend Strategic
Partnership Through Accelerated Supply of Urgently Needed
Lipids. Merck KgaA. 5 Feb. 2021.
2. Mantri, Shiksha. " Strategies for Successful Formulation
Development of Lipid-Based RNA Delivery and Vaccines. "
MilliporeSigma.
About the Author
Shiksha Mantri, Ph.D.
Global Technical Product Manager, Synthetic Lipids,
MilliporeSigma
Shiksha Mantri holds a Ph.D. in chemical Bbiology from
the University of Oxford, U.K., and did her postdoc at
ETH Zurich, Switzerland. She joined Merck as the global
Technical Product Manager for synthetic lipids, where
she was responsible for managing Merck's lipids portfolio
and custom manufacturing businesses. She continues to
support the top industry players and young start-ups in the
fields of RNA delivery and vaccines as the Global Marketing
Manager for RNA solutions.
14

eBook: Formulation Technologies and Strategies for Successful New Product Development

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