www.biopharminternational.com May 2022 eBook BioPharm International 27
panies when it came to the sterile bags
used for cell cultivation in bioreac-
tors (6). Despite the rise of globalized
supply chains in the past decade, the
COVID-19 pandemic has highlighted
the need to proactively monitor and
quickly react to potential delays.
Manufacturers had to identify sev-
eral potential sources of equipment
and consumables to have alternative
options in the event of delays from
their primary source. Identifying alter-
native suppliers close to the production
facilit y for localization of materials
helped to minimize risks associated
with delays. Additional time also had
to be taken to ensure that the alterna-
tive equipment and consumables iden-
tified were suitable and optimized for
the manufacturing needs.
THE POTENTIAL OF mRNA
The growing interest in mRNA tech-
nology is in part because of its abil-
ity to be easily edited, providing the
potential for it to be used in the treat-
ment of countless possible diseases. In
this way, mRNA technologies have
the ability to be used as a "plug-and-
play " plat for m, of fer ing unprece-
dented versatility. Recent advances in
mRNA vaccine technologies have fur-
ther improved translatability. Carriers
have also been developed to prolong
antigen expression in vivo, further
increasing its potential.
Additionally, vaccines that rely on
mRNA technologies provide the added
benefit of having the potential for inex-
pensive, rapid, and cost-effective scal-
able manufacturing. As mRNA can
be synthesized using relatively simple
in vitro transcription reactions, high
yields can be achieved with a small,
good manufacturing practice (GMP)
facility footprint.
A s a resu lt, mR NA tec h nolo-
gies are being used in abundance in
drugs currently at clinical trial. As
of July 2021, there were more than
70 mR NA therapeutics in clinical
pipelines globally and many more assets
in early development (7). The thera-
pies in development are to be used in an
array of therapeutic areas. These include
drugs for cancers (ovarian, lymphomas,
melanomas, and glioblastomas), isch-
emic heart disease, rare diseases (caused
by Zika virus, Chikungunya virus),
and more common diseases (caused by
Rabies virus, HIV) (8).
It is likely that demand for manu-
facturing support will persist for years
to come, especially with the imme-
diate need for COV ID-19 booster
vaccinations. CDMOs will need to
keep adapting to solve the challenges
associated with the storageof mRNA
technologies, as well as develop their
services to provideend-to-end mRNA
capabilities. Overcoming these issues
may in turn position the manufacturers
in a stronger position to support other
therapeutic modalities such as C>s
further on the horizon.
LESSONS LEARNED
AND MOVING FORWARD
With an increased demand for drugs
based on new technologies, CDMOs
will need to consistently demonstrate
their agility while ensuring quality and
safety in all stages of a product cycle.
This is essential to respond to other
new technologies and shifting market
dynamics. To achieve this, processes will
need to be highly optimized to reduce
timelines and provide speed to market.
T he pa ndem ic ha s h igh l ighted
that foresight, careful preparation,
and agilit y continue to be essential
traits for CDMOs and will prevent
them from mismanaging their prior-
ities. Client satisfaction and the lives
of patients are, and a lways should
remain, the highest priorities.
REFERENCES
1. W. Xie, B. Chen, and J. Wong,
Nat. Rev. Drug Discov., 20,
735–736 (2021).
2. FDA, Emergency Use
Authorization, Policy
Framework [content current
as of Jan. 25, 2022].
3. FDA, Priority Review information
available from fda.gov
[content current as of Jan. 4, 2018].
4. EMA, Conditional Marketing
Authorization information
available from ema.europa.eu
[accessed Jan. 25, 2022].
5. D. Stanton, "Single-Use Lead
Times up to 12 Months as
COVID Takes its Toll," BioProcess
International, May 3, 2021.
6. J. Feinmann, BMJ, 375 (8312)
n2375 (2021).
7. Statista, "Number of mRNA
Therapeutics in Clinical Pipelines
Worldwide as of July 2021, by
Therapy Area," Statistics (July
2021).
8. NIH, ClinicalTrials.gov, Database
[accessed Nov. 15, 2021].
BP
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