Cytiva_APR21_EarlyProcessDevDecisions - 9

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

Fig 1. CDMOs can provide substantial value to early-stage cell and gene therapy developers. PoC is point of care.

different set of technical, regulatory, access, and

very challenging to source for preclinical devel-

licensing considerations. A CDMO can help an

opment. CDMOs can leverage existing relation-

early-stage CGT developer understand the limita-

ships with public and private entities to help in

tions of their source cells. And the CDMO can

sourcing these materials.

aid in developing strategies around processing

Regardless of the source, it is critical to thor-

tissue, generating cell banks, or performing cell

oughly characterize the identity and quality of

line engineering.

the starting cell material in preclinical develop-

Engaging early with an experienced CDMO

ment. CDMOs can tailor process and assay devel-

can also help navigate the evolving and nebulous

opment programs around the unique needs of

regulatory landscape around CGT cell sources.

the biological input material.

Commercially available cell sources and vectors,
though often available for unrestricted use in

PROCESS SCALES AND CHANGES

academic and research settings, might carry

In the research stage of a new CGT, cell manipu-

licensing fees for clinical and commercial use. In

lations are manual, technically complicated, and

addition, primary cell and tissue sources can be

demonstrated only at laboratory scale for proof-

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Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Cover1
Cytiva_APR21_EarlyProcessDevDecisions - Cover2
Cytiva_APR21_EarlyProcessDevDecisions - Contents
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