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LIPIDS: PROTECTING MRNA SO IT CAN PROTECT OUR BODY
Underpinning the success of Covid-19 mRNA vaccines, lipid nanoparticles are set
to transform the future of medicine by enabling the delivery of cutting-edge
therapies into cells.
1.
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NO. 1 AGAINST COVID-19
In December 2020, less than a year after the full viral genome sequence of the
novel coronavirus SARS-CoV-2 was published, the first Covid-19 vaccines received
authorization in multiple countries, paving the way for mass vaccination
programs around the world.[1,2]
Traditional vaccines work by giving people either viral proteins or an
inactivated or weakened form of a virus, triggering the body to make an immune
response. But the crucial ingredient in two of the first Covid-19 vaccines –
BNT162b2 ("Comirnaty" from BioNTech/Pfizer) and mRNA-1273 ("Spikevax" from
Moderna) – was instead messenger ribonucleic acid (mRNA), the short-lived
intermediate genetic molecule between DNA and proteins. Both of these vaccines
employ synthetic mRNA molecules containing the instructions to make a specific
viral protein - the spike protein that helps SARS-CoV-2 to enter our cells.[3]
“With mRNA vaccines, the viral protein is produced inside cells in the body,”
explains Guido Krupp, Senior Research Fellow and founder of AmpTec GmbH, a
leading mRNA CDMO that was acquired by our company in January 2021. “This then
acts as an antigen, the foreign molecule that stimulates an immune response.”
DID YOU KNOW?
* 1961
saw the discovery of messenger RNA (mRNA). [4]
* 2020
the first mRNA vaccines against Covid-19 received approval. [2]
* 4
different types of lipids are typically used in Covid-19 mRNA vaccines.
PROTECTIVE WRAPPER
mRNA was first discovered in 1961.[4] Over the following decades, researchers
have been exploring the potential of mRNA vaccines for the prevention or
treatment of various diseases. But while the concept itself is straightforward,
the safe and effective delivery of these fragile nucleic acids into cells where
their message can be translated into proteins has proved a huge challenge.
“These molecules are inherently unstable, and they are rapidly broken down by
enzymes in the body,” says Gang Yao, who heads up our R&D team for lipid
nanoparticles. “It’s also hard to transfer them across the protective outer
layer of cells.”
For the new Covid-19 mRNA vaccines, the solution to this problem came through
the development of lipid nanoparticles (LNPs). These particles, typically
composed of four different lipids (ionizable lipids whose positive charges bind
to the negatively charged backbone of mRNA, pegylated lipids that help stabilize
the particle, and phospholipids and cholesterol molecules that contribute to the
particle’s structure), provide a protective wrapper for the delicate mRNA
molecules, enabling its safe and efficient delivery into cells.
“Each of these lipids plays an important role,” explains Yao. “They work
together to encapsulate the mRNA, protect it from degradation and get it into
cells.”
MRNA: SUCCESSFULLY DELIVERED
The potential of LNPs as a sophisticated drug delivery system was first
highlighted by their successful application in another cutting-edge form of
RNA-based therapy that uses short interfering RNAs (siRNAs).
In 2006, Andrew Fire and Craig Mello were awarded the Nobel Prize in Physiology
or Medicine for their discovery of a mechanism that can break down mRNA from a
specific gene.[5] The mechanism, called RNA interference, opened up exciting new
possibilities for the therapeutic use of RNA molecules designed to switch off –
or silence – the activity of specific genes in cells.
In 2018, the world’s first siRNA-based drug was approved by the US Food and Drug
Administration (FDA) – a new treatment for a rare, life-threatening disease
called hereditary transthyretin-mediated amyloidosis.[6] This medicine contains
a very short piece of RNA that was designed to silence the disease-causing gene
in the patient’s liver. The efficient delivery of the siRNA into these cells is
critically dependent on LNP technology.[7]
Two years later, the approval of two Covid-19 mRNA vaccines within mere days
marked the next major milestone in the LNP field.
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SCALING UP LIPID PRODUCTION
After the extraordinary speed at which Covid-19 vaccines were developed and
approved created, another huge challenge emerged: the manufacture and
distribution of enough life-saving doses at the quality, speed, and scale
required to combat the pandemic.
Very few companies in the world could manufacture the lipids in sufficient
quantities and especially at the required standards of quality for Covid-19 mRNA
vaccine formulations. As a global leader in lipids, we have more than two
decades of experience in providing custom lipids and other critical components
such as synthetic cholesterol for lipid nanoparticles, following appropriate
Good Manufacturing Practices (GMP) for these types of products to ensure the
highest safety standards.
“We worked hard to expand our already very high lipid production capacity to
help meet the unprecedented demand,” says Tobias Haag, Head of our Process and
Analytical Development team.
In February 2021, we extended our strategic partnership with BioNTech to
significantly accelerate the supply of urgently needed lipids to support the
production of the Pfizer-BioNTech Covid-19 mRNA vaccine Comirnaty. Three months
later, we launched a new, high-purity synthetic cholesterol product, nine months
ahead of schedule.
“We developed a safe, reliable manufacturing process and created the regulatory
documents for filing with the global authorities, all in record time,” reflects
Haag. “It was a very intense time for everyone, but the purpose and intent of
helping to fight the pandemic provided us with a source of energy to give it our
best efforts.”
This new SAFC® synthetic cholesterol product increased our manufacturing
capacity by 50 times, helping to support global efforts to manufacture
life-saving Covid-19 mRNA vaccines that have now reached billions of people
worldwide. In 2022, it is projected that about 40% of all manufactured Covid-19
vaccine doses will be based on mRNA.[8]
HELPING TO FIGHT COVID-19
Our constant curiosity and specialist approach drive our partnerships and bring
new ideas to life. In our Media Center, we bundled all information about our
engagement to fight Covid-19.
READ MORE
TBA: MORE RNA THERAPEUTICS
Recent advances in mRNA technology, accelerated by the Covid-19 pandemic, herald
a new era of genetic medicine.
Flexible mRNA-based vaccine platforms can cut development time dramatically
compared to conventional approaches using proteins or inactivated pathogens —
enabling much more rapid responses to future emerging infectious diseases. A
variety of other mRNA vaccines are currently in development to combat existing
pathogens that threaten lives today — including the human immunodeficiency virus
(HIV), the flu virus, and the parasite that causes malaria.[9]
But the potential applications extend far beyond preventative vaccines.
RNA-based therapeutics – including mRNA – offer the promise of new treatments
for a variety of infectious diseases, genetic conditions, cancer, and other
illnesses.
“Since mRNA has the ability to code for any protein that you want, you could use
it to replace faulty or deficient proteins, or to prime a patient’s immune
system to fight infections or kill cancer cells,” says Krupp.
The enthusiasm around mRNA therapeutics is evident from the number of companies
backing the technology. There are currently more than 420 active mRNA programs
in (pre-)clinical development testing mRNA for over 120 different diseases —
including more than 110 programs for a variety of cancers as well as
approximately 100 programs for rare and other diseases.[10]
DID YOU KNOW?
There is so much to learn about mRNA. Some things we don’t even know yet, but
some we do. Test your knowledge of this game-changing technology!
Question 1/3
HOW MANY DIFFERENT TYPES OF LIPIDS ARE IN COVID-19 MRNA VACCINES?
4
10
2
Submit
SPOILER ALERT: IT’S GOING TO BE HEALTHY
The Covid-19 pandemic has helped to accelerate incredible scientific advances,
leading to the approval of the first-ever mRNA vaccines.
But this is only the beginning of the story. Next-generation RNA-based
therapeutics, delivered into cells in LNP formulations, are now poised to
transform the future of medicine – offering the promise of new treatments for
many different diseases
With more than 20 years of experience providing critical components for mRNA
therapies, we have recently further expanded our mRNA manufacturing
capabilities. In February 2022, we acquired Exelead, a full service CDMO
covering all phases from pre-clinical development to commercial manufacturing
for LNP formulations, including fill/finish. By combining Exelead’s capabilities
with AmpTec’s expertise in the development and manufacture of custom mRNAs and
our extensive experience and strengthened capabilities in lipids manufacturing,
we can now provide a fully comprehensive portfolio of products and services
essential for RNA-based therapeutics development.
“We want to be part of this growth story from the very beginning,” says Timon
Lentz, Global Marketing Lead for our drug delivery portfolio. “I find it super
exciting to be involved in something where the future is still being shaped.”
OUR CONTRIBUTION
In 2012, the United Nations set out 17 Sustainable Development Goals (SDGs) that
meet the urgent environmental, political and economic challenges facing our
world. Three years later, these were adopted by all member states. We are
committed that our work will help to achieve these ambitious targets. Our work
in lipid production for mRNA vaccines fits under ‘Goal 3 — Good health and
well-being; Target 3.3 — end epidemics from communicable diseases.’ Contributing
to global efforts to end the Covid-19 pandemic through the delivery of safe and
effective vaccines has helped to save countless lives around the world.
Learn more about SDGs
REFERENCES
[1] https://www.nature.com/articles/s41586-020-2008-3
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7844189/
[3] https://www.nature.com/articles/s41541-021-00369-6
[4] https://www.sciencedirect.com/science/article/pii/S0960982215006065
[5] https://www.nobelprize.org/prizes/medicine/2006/summary/
[6] https://pubmed.ncbi.nlm.nih.gov/30251172/
[7] https://pubmed.ncbi.nlm.nih.gov/31397996/
[8] https://launchandscalefaster.org/Covid-19/vaccinemanufacturing
[9] https://www.cbinsights.com/research/what-are-mrna-therapies/
[10] PharmaCircle analysis - June 2022
WORK WITH US
MORE THAN A SMALL PART TO OUR SUCCESS: YOU.
Do you want to make the world a healthier place? Join us and make a difference –
whether that’s with small particles that help accelerate mRNA technology or in
any other field. Your contribution definitely isn’t on a nanoscale. We can’t
wait for your application to be safely delivered!
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Additionally, keyboard users will find content-skip menus available at any
time by clicking Alt+2, or as the first element of the site while navigating
with the keyboard. The background process also handles triggered popups by
moving the keyboard focus towards them as soon as they appear, not allowing
the focus to drift outside.
Users can also use shortcuts such as “M” (menus), “H” (headings), “F”
(forms), “B” (buttons), and “G” (graphics) to jump to specific elements.
Disability profiles supported on our website
* Epilepsy Safe Profile: this profile enables people with epilepsy to safely
use the website by eliminating the risk of seizures resulting from flashing
or blinking animations and risky color combinations.
* Vision Impaired Profile: this profile adjusts the website so that it is
accessible to the majority of visual impairments such as Degrading Eyesight,
Tunnel Vision, Cataract, Glaucoma, and others.
* Cognitive Disability Profile: this profile provides various assistive
features to help users with cognitive disabilities such as Autism, Dyslexia,
CVA, and others, to focus on the essential elements more easily.
* ADHD Friendly Profile: this profile significantly reduces distractions and
noise to help people with ADHD, and Neurodevelopmental disorders browse,
read, and focus on the essential elements more easily.
* Blind Users Profile (Screen-readers): this profile adjusts the website to be
compatible with screen-readers such as JAWS, NVDA, VoiceOver, and TalkBack. A
screen-reader is installed on the blind user’s computer, and this site is
compatible with it.
* Keyboard Navigation Profile (Motor-Impaired): this profile enables
motor-impaired persons to operate the website using the keyboard Tab,
Shift+Tab, and the Enter keys. Users can also use shortcuts such as “M”
(menus), “H” (headings), “F” (forms), “B” (buttons), and “G” (graphics) to
jump to specific elements.
Additional UI, design, and readability adjustments
1. Font adjustments – users can increase and decrease its size, change its
family (type), adjust the spacing, alignment, line height, and more.
2. Color adjustments – users can select various color contrast profiles such as
light, dark, inverted, and monochrome. Additionally, users can swap color
schemes of titles, texts, and backgrounds with over seven different coloring
options.
3. Animations – epileptic users can stop all running animations with the click
of a button. Animations controlled by the interface include videos, GIFs,
and CSS flashing transitions.
4. Content highlighting – users can choose to emphasize essential elements such
as links and titles. They can also choose to highlight focused or hovered
elements only.
5. Audio muting – users with hearing devices may experience headaches or other
issues due to automatic audio playing. This option lets users mute the
entire website instantly.
6. Cognitive disorders – we utilize a search engine linked to Wikipedia and
Wiktionary, allowing people with cognitive disorders to decipher meanings of
phrases, initials, slang, and others.
7. Additional functions – we allow users to change cursor color and size, use a
printing mode, enable a virtual keyboard, and many other functions.
Assistive technology and browser compatibility
We aim to support as many browsers and assistive technologies as possible, so
our users can choose the best fitting tools for them, with as few limitations as
possible. Therefore, we have worked very hard to be able to support all major
systems that comprise over 95% of the user market share, including Google
Chrome, Mozilla Firefox, Apple Safari, Opera and Microsoft Edge, JAWS, and NVDA
(screen readers), both for Windows and MAC users.
Notes, comments, and feedback
Despite our very best efforts to allow anybody to adjust the website to their
needs, there may still be pages or sections that are not fully accessible, are
in the process of becoming accessible, or are lacking an adequate technological
solution to make them accessible. Still, we are continually improving our
accessibility, adding, updating, improving its options and features, and
developing and adopting new technologies. All this is meant to reach the optimal
level of accessibility following technological advancements. If you wish to
contact the website’s owner, please use the website's form
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accessibility interface, you won't be able to see it anymore, unless you clear
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