Cytiva_APR21_EarlyProcessDevDecisions - 22

Cell Therapy Manufacturing Tries " Building the Plane While Flying It "

to seek out expertise and update requirements.

as qualified personnel are also being actively

He notes that reforms adopted by Japan's Phar-

recruited by well-capitalized companies crafting

maceuticals and Medical Devices Agency have

the regulatory submissions. "

rippled through the Asia-Pacific region, and

This view is shared by Burger, who says, " Regu-

that actions taken by the Gottlieb-era FDA have

lations for cell therapy and gene therapy products

contributed to significant progress.

are actually very well developed at this point,

" On the one hand, the sheer volume of
submissions has left regulators scrambling to
find headcount to provide timely review, " Davies
states. " But on the other hand, the technical

particularly in the United States, Europe, and
much of Asia. "

COMMON STANDARDS

complexity and novelty of the products makes

In cell therapy manufacturing, regulatory

such human capital hard to find, especially

development is still in progress. To make this

Pall and Recursion Collaborate on Human
Umbilical Vein Endothelial Cell Scaleup
Efficiently growing cells-whether for cell

discovery and development at scale. We're trying

therapy, drug screening, or process develop-

to build a really large data set of these different

ment-is crucial to the pharmaceutical business.

drug screens, and we need to produce a lot of

Crucial, too, is assuring that those cells consis-

primary cells to accomplish those, " says Dylan

tently maintain the attributes critical to their

Knutson, an HTS biomedical engineer at the

utility, sometimes even beyond standard single-

company. He presented the results of the collab-

assay measures.

oration at last month's Informa Cell and Gene

Recursion Pharmaceuticals and Pall Biotech
collaborated on a pilot project to transfer
expansion of human umbilical vein endothe-

Therapy Bioprocessing and Commercialization
conference in Boston.
Adherent HUVECs were grown on colla-

lial cells (HUVECs) from standard spinner flasks

gen-based microcarrier beads. Those expanded

to the Pall Allegro™ STR stirred tank bioreactor

in the bioreactor doubled significantly faster,

platform. " At Recursion, we're basically doing drug

reached confluence a day earlier, and showed

22 |

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Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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