Cytiva_APR21_EarlyProcessDevDecisions - 23


point, Fachin contrasts the cell therapy field

are made: " Recently, I had the privilege of

with more mature fields. In mature fields, he

leading a workshop on tool integration at

says, industry standards are well established,

Phacilitate Automation SIG, where represen-

whereas in cell therapy, regulatory agencies

tatives of cell therapy manufacturers, device

such as the FDA, the European Medicines

manufacturers, regulators and, raw materials

Agency, and the Pharmaceuticals and Medical

manufacturers came together. A unified

Devices Agency " are indeed still working with

session outcome was the fact that democratic

academic and industrial institutions to outline

academic/industry/regulatory engagement to

cell therapy standards. "

define cell therapy 'standards' (at the hardware,

And according to Fachin, all parties agree

software, device interfaces, manufacturing,

that collaborating to set common standards

analysis, and release levels) is a must for

will help industry to improve how cell therapies

long-term scalability and sustainability. "


significantly better viability upon freeze-thaw
than those in spinner flasks. Both methods
Nahidiazar L, Agronskaia A, Broertjes J,
van den Broek B, Jalink K / Creative Commons

allowed the cells to maintain critical quality
attributes (CQAs), for example, as demonstrated
by the formation of tubules in the presence of
vascular endothelial growth factor in a traditional
angiogenesis assay.
" But then we took it a lot further, " Knutson
explaines. Standardly grown cells were screened

Microscopic image of the keratin cytoskeleton of a HUVEC cell.

with 90 compounds from various drug classes

This was used to successfully predict, for

at three different concentrations and stained

example, the class of compound in an assay with

with the multiparametric fluorescent Cell

bioreactor-generated cells.

Painting assay, allowing them to be analyzed

" We get a really robust measure of function

across more than a hundred features with Cell

and performance, " Knutson says, adding that this

Profiler software. These data were used to train a

approach can ensure the consistency

machine learning algorithm to classify different

of these features in every batch of cells for their

phenotypes and correlate them with treatment.

sensitive assays.


| 23


Table of Contents for the Digital Edition of Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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