Cytiva_APR21_EarlyProcessDevDecisions - 16

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

Cell Therapy Manufacturing Tries
" Building the Plane While Flying It "
Early approvals of cell therapy products may accelerate
manufacturing timelines, which must then accommodate
technology upgrades as they become available

A

nything that is worth doing-including

Kymriah (tisagenlecleucel) for children and young

cell therapy manufacturing-is worth

adults with refractory or relapsing acute lympho-

doing imperfectly at first. Refinements

blastic leukemia. The agency based its decision on

can wait. In the meantime, cell therapies can

evidence of high remission rates in three Phase

benefit patients who lack other options. Also,

I/II studies. Likewise, the FDA approved Gilead's

any improvements that are made on the fly can

Yescarta (axicabtagene ciloleucel) for adults

contribute to an iterative development cycle. If

with large B-cell non-Hodgkin lymphoma based

cell therapy manufacturers can maintain a flight

on data from a Phase I/II trial. In this trial, called

path while development proceeds, there's no

Zuma-1, a remission rate of 51% was achieved.
For some therapies, early approvals-that is,

telling how far they might go.
Cell therapy products that generate impressive

approvals based on early clinical trial data-make

early-phase clinical trial data may be cleared for

sense, particularly if alternative treatments do

takeoff by the U.S. Food and Drug Administration

not exist. Early approvals also present production

(FDA). For example, the FDA approved Novartis'

opportunities. These opportunities, however,

Basics of process development
for biotherapeutics
Definitions, activities, and things
to consider when developing
an upstream or downstream
bioprocessing.

16 |

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