Medical Design Briefs - January 2023 - 11

Modernizing
Therapeutic Cell Production
C
ell and gene therapies are
dominating the world of drug
development. With the promise
of significant breakthroughs
in treatment of diabetes,
cancer, and congenital conditions,
it is no wonder that research and development
is predicted to reach $232.5 billion
by 2026, up from $186 billion in 2019,
according to the Evaluate Pharma report.
With so much at stake, attention is
now shifting to adopting more modern
equipment and methods to consistently
produce the best cells. At the core of this
trend is replacing outdated legacy manufacturing
techniques where cells are exposed
to air, even if meticulously filtered
air, and the negative consequences of
that. It is a simple sounding concept.
Since the beginning, Good Manufacturing
Practices (GMP) have been based
on the use of cleanrooms and isolators.
However, the industry is moving toward
superior alternatives that accomplish
what any air environment cannot: better
protection of cells from both microbial
Medical Design Briefs, January 2023
contamination and chemical toxicity,
and better control of the universal critical
cell process parameters - temperature,
CO2
, and O2
. The key is closure,
another simple sounding concept.
Without closure and separation from
air, even highly filtered air, protection
from microbial contamination in cleanrooms
and traditional isolators is dependent
on the liberal use of gaseous and
liquid chemical microbial biocides.
However, they are toxic to the cells too.
In GMP, scientists must prove they are
not harming cells, which takes tremendous
effort. Even then, it is impossible
since the damage is often insidious. In
addition, emerging science tells us exposure
to air, even short exposures, can degrade
genotypic and phenotypic integrity
and contribute to variability in cell
populations. It causes suboptimal transients
of those three critical cell process
parameters. Yet this is the norm in cleanrooms
and traditional isolators.
Cells produced in a more favorable
environment produce better cells, both
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in terms of the number and consistency
of cells produced and most important
their therapeutic potency. For these reasons,
moving away from legacy facilities,
equipment, and practices is essential for
advancing cell-based therapies.
Single-Use Technology
One only needs to read the industry
news to see where it is headed. Take the
popularity of presterilized, single-use systems
(SUS), which have exploded in use.
Keeping cells aseptic inside a presterilized
bag, bag/tube assembly, or cassette
is easy. There is less cleaning and virtually
no biocide needed. Add to that the
productive functionality of their associated
mechanical devices, including and up
to full automation, and it explains why
these closed SUS devices are a dominant
trend in modernization.
Some are unifunction SUS devices, designed
for one step in production (e.g.,
cell separation). Some are multifunction
SUS devices that do several steps (e.g.,
cell washing and dilution). Some actual11
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Medical Design Briefs - January 2023

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