Medical Design Briefs - January 2023 - 13

Cell production often consists of many
widely diverse steps. Technicians or industrial
robotic arms use the gloves from
the outside for manual or man-mimetic
robotic steps, or for tending to the
equipment or automation inside.
However, in the context of producing
high-quality cells by avoiding contamination
and toxic chemicals, it is more comparable
to SUSs.
Although it is not an SUS, it makes aseptic
cell production easy. Instead of ease with
presterilized disposables, it self-sanitizes the
entire internal production environment
automatically without risky biocides. No
biocides may sound like heresy according
to GMP dogma, but it works, and the data
trumps the dogma. In this regard, it could
also be called a next generation isolator, or
cytocentric isolator.
Instead of air inside, it is filled with a
mix of pure N2, O2, and CO2
tanks. CO2 and O2
gases from
can be controlled at
optimal levels for cells throughout the
system, just like an incubator or bioreactor.
Temperature can also be controlled,
just like an incubator or bioreactor.
By eliminating the fluctuations and
transient exposures to suboptimal temperature,
CO2
, and O2
usually caused by
all the typical exposures to air in cleanrooms
or traditional isolators, it produces
cells with better consistency and quality.
Sometimes radically better.
Notably, most stem cells and primary
cultures fresh from the patient do best
at low O2
levels, which simulate normal
physiologic levels. In fact, it is the only
cell manufacturing platform that can
optimize this critical parameter at every
step of production, simultaneously with
physiologic CO2
and temperature. However,
where necessary, a technician can
simulate air without air, inert with 100
percent nitrogen, or chill down to refrigerator
temperatures.
Compared to cleanrooms, it reduces
facility costs by 90 percent when compared
with total cost of ownership at
equivalent production capacity over the
facility life cycle. Extremely low operating
cost is the game changer, although
many forget to factor that into future
facility cost estimates.
It brings cGMP cell production within
reach of even the smallest companies.
Combine that with the speed and
flexibility of deployment, multi-modal
capability due to closure, easy path to
regulatory approval due to closure, reduction
in virtually all the risks, and
high quality of the live cell products, it
is next generation regardless of what it
is called.
Reference
1. Song H, Shao L, Prochazkova M, et al., 145 Comparison
of CAR-T cell manufacturing platforms
reveals distinct phenotypic and transcriptional
profiles, Journal for ImmunoTherapy of Cancer, 2021.
This article was written by Randy
Yerden. He is a cell biologist and CEO
of New York-based BioSpherix, Ltd.,
Parish, NY, a designer and manufacturer
of cell incubation, processing,
and production systems. For more
information about BioSpherix, visit
www.biospherix.com. For more information
about the Xvivo System, visit
www.biospherixmedical.com or call
800-441-3414.
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Medical Design Briefs - January 2023

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