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Growing Interest In mRNA Capabilities
Although many people did not know about
mRNA until it ushered us toward a return to
normalcy during the COVID-19 pandemic,
researchers have been studying the capabilities
of RNA-based vaccines and therapeutics
for almost 30 years. The potential of mRNA
was first discovered by Hungarian scientist
Katalin Kariko in the 1990s1; yet, advancing it
beyond an idea proved difficult, due to the
body's natural immune response to synthetic
RNA. Kariko, along with immunologist Drew
Weissman, eventually overcame this hurdle
by incorporating modified nucleosides into
mRNA, laying the foundation for its use in the
vaccines later developed for COVID-19.1
The expected growth of the mRNA market signals
the success of the Moderna and Pfizer-BioNTech
vaccines as only the beginning of a new era in
the biopharmaceutical industry. In 2019-just
before the COVID-19 outbreak-the mRNA
vaccines and therapeutics market was valued
at almost $600 million.2 Now, recent reports
show this number could be as high as $2,911.9
million by 2026,2 with 155 therapies based on
mRNA already in today's clinical pipeline.3
There are three parameters
driving interest in mRNA:
1. Safety. mRNA vaccines do not involve
infectious elements like many conventional
vaccines. mRNA is also degraded rapidly after
injection by normal cellular processes.
2. Speed. It is produced more rapidly by cellfree
processes than other biologics and is
readily standardized and scaled up, improving
responsiveness to large emerging outbreaks.
3. Efficacy. It induces expression of specific
antigens that give rise to both humoral
(antibodies) and cell-mediated immunity
(T cells), which results in efficient and effective
immune response.
Dr. Jing Zhu, associate director of mRNA development
at GeneLeap Biotech, says the success
of the Moderna and Pfizer-BioNTech vaccines
drove significant changes in his company's
plans for the future. " Last year, GeneLeap
Biotech had three areas of focus when it came
to developing the vaccines and therapies in
our pipeline: AAV [adeno-associated virus],
oligonucleotides, and mRNA, " he explains. " But
because of the success with the COVID-19
vaccines, we strategically shifted our main efforts
to mRNA. Not only does it have the power to
do things traditional modalities do not, but the
development timelines and investment needed
for mRNA are much less than other biologics. "
The impact of mRNA's success in 2020 was
also felt at the Centre for Process Innovation
(CPI), a part of the UK government's High Value
Manufacturing network which has an objective
of providing process development support
and manufacturing expertise to the biopharma
industry. Over the last year, CPI was a key part
of the UK government response to support
rapid vaccine development against COVID-19. | 17


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