Enabling a Healthier World

www.lonza.com

mRNA/LNP Development
and Manufacturing Services
An end-to-end offering from a CDMO with extensive
experience in cGMP mRNA/LNP manufacturing

Messenger RNAs (mRNAs) represent a fast-emerg-

ing class of biotherapeutics. They hold considerable
promise, offering new opportunities for targeted
treatment and flexible manufacturing, as was re-
cently demonstrated by the rapid development of
mRNA-based COVID-19 vaccines. In recent years,
we at Lonza have amassed considerable expertise
in the commercial manufacturing of mRNA and its
encapsulation in Lipid Nanoparticles (LNP) at cGMP
quality.
Enabling a Healthier World
Our Services
In response to growing customer demand, we have decided
to expand our mRNA clinical manufacturing services through-
out the course of 2023. This will allow tech transfers and
process development activities to begin in Q1 of 2023. Learn
more about these upcoming services at Lonza below.
Careful management of the new manufacturing processes
and the complex supply chain are crucial factors to success
when manufacturing mRNA formulations. This includes
having a reliable sourcing strategy for the DNA template,
a robust and efficient mRNA in vitro transcription process
with a clever capping approach, a stable encapsulation
of mRNA in LNP as well as a reliable partner for the sterile
filling of vials. Bringing all these processes together may be
complex, but we have all the essential equipment for mRNA/
LNP manufacturing in place, and offer all key elements in
one network at cGMP quality. As part of our services we
also manufacture circular mRNA, self-amplifying mRNA, as
well as other forms of mRNA that can be produced through
in vitro transcription processes.
DNA template supply
The DNA template is a critical raw material for mRNA manu-
facturing and the starting point for the in vitro transcription
of mRNA. At Lonza, you have the freedom to select the most
suitable source for your DNA template — we will help you
make the right choice of a supplier and provide you with an
efficient IVT process with the best results. Whether your pref-
erence is pDNA derived from E. coli or synthetic Doggybone™
DNA from our strategic partner Touchlight, we will manage
the complexities for you.
mRNA/LNP process development (PD)
Once you have selected your lead compound, we will
assist you in developing a cGMP-compliant manufacturing
process. Leveraging our deep understanding of cGMP re-
quirements and experience with mRNA/LNP manufacturing,
we will help define the optimal manufacturing process for
you. Whether it is to develop a new IVT/LNP cGMP process
for your mRNA compound, or to tech transfer and optimize
your current process to meet all cGMP requirements, our
competent staff at our site in Geleen, the Netherlands, will
be quick to accommodate your needs. Our scientists and
engineers have 30,000 square feet of laboratories, clean
rooms, offices, storage and other essential utilities at their
disposal to help you realize your goal.
2
Analytical development (AD)
We have co-located both analytical development and pro-
cess development at one site, granting you several benefits
in regards to analytical test methods. With AD and PD in
one place, you can employ the same mRNA assay for your
mRNA Drug Substance, your mRNA/LNP Drug Product Inter-
mediate, as well as your finished Drug Product. Co-location
also avoids cumbersome tech transfers between various
labs, and greatly reduces the likelihood of inconsisten-
cies emerging in test results. Our mRNA team has plentiful
experience with all relevant compendial methods for mRNA/
LNP formulations, and has access to numerous pertinent
technologies, such as in-house mass spectrometry and cell-
based bioassays. Apart from the immediate mRNA team,
you will also benefit from the wealth of experts within the
greater global Lonza network.
mRNA manufacturing
We strive for seamless tech transfers and are committed
to adjusting your existing processes towards greater sta-
bility. We have gained extensive experience in establishing
mRNA/LNP manufacturing, and have successfully delivered
large amounts of cGMP-compliant material. We suggest
starting with a traditional service and manufacturing model
that focuses on the supply of batches and distinct delivera-
bles. Our collaboration models are varied and customizable,
including the option to manufacture in dedicated suites, as
well as output- or input-based pricing models. This affords
you significant leeway when manufacturing your batches.
For example, once you are ready to progress to commercial
development, you can effortlessly switch to another scale
within the Lonza network. When compared with investing
in your own mRNA manufacturing facility, our options not
only offer greater flexibility, but also reduced overall finan-
cial exposure.
Lipid Nanoparticle encapsulation
In Geleen, we house several different technologies for lipid
mixing and LNP encapsulation and, therefore, are well-
equipped to offer you tailor-made solutions. We are dedi­
cated to continually improving our existing encapsulation
technology to ensure a simple scale-up from early clinical
to commercial assets. With both our mRNA manufacturing
and LNP encapsulation services co-located at our site in
Geleen, you avoid the laborious shipment of mRNA across
sites and borders, reduce the need for additional freezes
and thaws, and ultimately benefit from a unified analytical
and quality control team. We also offer “stand-alone” LNP
process development and manufacturing services, includ-
ing, but not limited to, getting your in vivo LNP-mediated
CRISPR gene-editing therapy cGMP ready.
Fill & Finish
If you are looking to streamline and reduce the complexity of
your processes, we are able to provide Fill & Finish services
for your mRNA drug substance, or your LNP encapsulated
mRNA intermediate from our manufacturing network. For
example, at our Swiss sites in Visp, Stein, and Basel, we offer
such services, including freeze-drying capabilities.
Regulatory
Take advantage of our regulatory services when writing CMC
documents for mRNA/LNP compounds, for supporting your
CMC strategy, and when you need support during your
Health Authority meetings. We have successfully supported
the development and approval of an mRNA/LNP product, so
we are able to provide you with the essential first-hand regu-
latory experience you will need from start to finish – including
the know-how when interacting with Health Authorities from
around the world. Our expertise will help you de-risk your
strategy and support a “right-first-time approach.”

Ability to provide end-to-end offerings for mRNA/LNP

Lipid
DNA mRNA Nanoparticles (LNP) Fill & Finish Regulatory

– E. coli-derived, – In-vitro – Lipid mixing – Liquid vials – Preparation of

linearized pDNA transcription CMC documents
(upstream) – mRNA – Lyophylisates for INDs, CTAs,
– Synthetic encapsulation BLAs and MAAs
Doggybone™ DNA – Purification in LNPs – Multiple clinical
(downstream) and commercial – Regulatory
– Analytics scales consulting
– Analytics
– Multiple clinical – Support of Health
– Multiple clinical and commercial Authority meetings
and commercial scales
scales

Why Lonza?
– We have successfully supported development and – One of the leaders in supply chain management,
approval of an mRNA/LNP product, making us the with experience in sourcing for mRNA/LNP products,
CDMO with the most extensive cGMP experience even during the most critical times.
in this space.
– First-hand experience from previous regulatory
– Key expertise is provided across all the modalities submissions for an mRNA/LNP vaccine.
required for mRNA/LNP manufacturing, all linked
by one Quality System.

– Leading LNP technologies offered, and continually

investing in innovation to further improve LNP
encapsulation at clinical and commercial scales.

3
Enabling a Healthier World

Our mRNA/LNP Locations within the Greater Biologics Network

Bend, USA Hayward, USA Portsmouth, USA Geleen/Maastricht, NL Visp, CH

Small Molecules Biologics Biologics mRNA and Biologics
– Oral Inhalation – Small-scale mammalian – Large and mid-scale Cell & Gene Technologies – mRNA/LNP suites
– Particle Engineering manufacturing mammalian manufacturing – mRNA/LNP suites – Parenteral fill and finish
– Bioconjugation
– Mid-scale microbial
manufacturing
– Small- and large-scale
mammalian manufacturing
Small Molecules
– API and HPAPI

Basel/Stein, CH
Drug Product Services labs

Houston, USA Tampa, USA Greenwood, USA Tuas, SG Nansha, CN Guangzhou, CN

Cell & Gene Technologies Small Molecules Capsules Biologics Small Molecules Biologics
– HPAPI – API – Small-scale mammalian
manufacturing

• Clinical mRNA/LNP development and manufacturing services

Our campus in Geleen, the Netherlands

Contact us
The information contained herein is intended for general marketing purposes only. While Lonza makes
efforts to include accurate and up-to-date information, it makes no representations or warranties, expressed

Contact us at mRNA@lonza.com for more details,
or visit us at lonza.com/biologics/mrna-services
or implied, as to the accuracy or completeness of the information provided herein and disclaims any
liability for the use of this publication and that all access and use of the information contained herein are at
their own risk. Lonza may change the content of this publication at any time without notice but does not
assume any responsibility to update it. All trademarks belong to Lonza and are registered in Switzerland
or to their respective third party owners.

© 2022 Lonza. All rights reserved. 1222.1