PHCbi-Panasonic eBook - 26

Cell Therapy Today * New Developments in Immunotherapy * Cell Therapy Production Moves to Factory Floor

the literature with a final yield of 2 billion cells/L.
Further characterization by immunocytochemistry,
flow cytometry, karyotype analysis, and differentiation into all three germ layers confirmed that
the human iPSCs retained their pluripotency and
normal karyotype after expansion.

GE Healthcare and CCRM (Centre for
Commercialization of Regenerative
Medicine) scientists explain GE's cell
processing equipment while giving a
tour of CCRM's laboratories in Toronto,
Canada. Funded by grants totaling
$40 million from GE Healthcare and
Canada's FedDev program, the facilities
substantiate Toronto's bid to become
"Stem Cell City."

Their innovative strategy eliminates microcarriers
or special surface coatings by culturing the iPSCs
in small cell aggregates formed from single cells.
They maintained cell viability and functionality
by optimizing critical parameters, like aggregate size and agitation rate, to ensure delivery
of oxygen and essential nutrients while also
minimizing shear stress. According to Dr. Heron,
their work "suggests that iPSCs can be cultured
in stirred suspension for at least 49 days, possibly
even longer, while remaining remarkably viable
and pluripotent, which is definitely a strong foundation for a scalable manufacturing process."

Taking the World by Storm
While allogeneic therapies follow a traditional
scaleup model, albeit at a smaller scale than
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conventional biologics, autologous therapies,
which are customized for each patient, require an
unconventional "scale out" model. "From a manufacturing standpoint, producing autologous
therapies at scale seemed ridiculously challenging," remarked Phil Vanek, general manager,
cell therapy growth strategy, GE Healthcare Life
Sciences.
The apprehension around manufacturing custom
therapies dissipated when CAR-T therapies,
based on pioneering research conducted by Carl
H. June, M.D., at the University of Pennsylvania,
entered the clinic as a cancer treatment.
"These therapies were taking the clinical world by
storm," recalled Dr. Vanek. "Patients that typically
had a less than 10% chance of survival suddenly
had remission rates above 80%. It was that clinical success that made the entire industry take
note and say, 'okay, if these therapies really work,
how can we manufacture them for everyone who
needs them?'"
Bridging the gap between scientific discovery

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PHCbi-Panasonic eBook

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