Cytiva_APR21_EarlyProcessDevDecisions - 11

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

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Nuclear transfer, Stem cells made from the cell nucleus

tion, can also be a strategy to start a small project

to run in a QC lab, a critical reagent is no longer

with the CDMO to determine whether they are

available, or the method is no longer relevant

the right partner.

based on clinical data - require lengthy and costly

Ideally, a company would use the same

equivalency studies to be carried out. Having an

qualified analytical methods from early process

established relationship with a CDMO, in which key

development to commercial manufacture. This

assays can be run consistently and comparably to

ensures consistency and comparability of data

other sites, also allows for both efficient compara-

throughout the life cycle of the CGT product. Also,

bility studies and smoother tech transfer.

it is important to have robust assays for CQAs
in place before starting major process changes,

ORGANIZED AND DOCUMENTED
TECHNOLOGY TRANSFER

as use of these assays will serve to ensure that
manufacturing changes are not having an adverse

Effective, efficient technology (tech) transfer

impact on the final product. Changes in methods

strategies assure processes are moved to a

between different phases of clinical trials -

CDMO's environment successfully. Tech transfer

whether it is because a method is too challenging

is a complex undertaking that requires commu-

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Cytiva_APR21_EarlyProcessDevDecisions

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Contents
Cytiva_APR21_EarlyProcessDevDecisions - Cover1
Cytiva_APR21_EarlyProcessDevDecisions - Cover2
Cytiva_APR21_EarlyProcessDevDecisions - Contents
Cytiva_APR21_EarlyProcessDevDecisions - 4
Cytiva_APR21_EarlyProcessDevDecisions - 5
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