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EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

practices from design controls used in medical

Having an established relationship with a CDMO

device development and in vitro diagnostics.

that runs key assays consistently to other sites

These methods include defining design inputs

allows for efficient comparability studies and

by building a user requirement specification for

facilitates smooth tech transfer.

each analytic, so that the assay chosen truly fits the
intended purpose. Examples of specifications to

ANCILLARY MATERIALS

consider include sensitivity, specificity, turn-around

To reduce the risk of transmissible diseases and

time, cost per test, and the robustness of the assay.

contamination in CGT products, there has been a

Having an established
relationship with a CDMO that
runs key assays consistently to
other sites allows for efficient
comparability studies and
facilitates smooth tech transfer.
Ideally, a company would use the same
qualified analytical methods from early process
development to commercial manufacture. This

concerted push toward the use of xeno-free (XF)
reagents, animal-derived component free (ADCF)
materials, and pre-sterilized single-use disposables with closed access ports. These choices can
also affect cell quality, as supported by a recent
example showing that serum-free media might
improve potency and transduction of CAR T cells
both in vitro and in vivo compared to serum-containing media.1
Many ancillary material manufacturers are

ensures consistency and comparability of data

now offering reagents and consumables to

throughout the life cycle of the CGT product. It

support CGT developers. These materials can

is important that robust assays for CQAs are in

be up to ten times more expensive than their

place before initiating major process changes.

research use only (RUO) counterparts. And they

This is true because use of these assays will serve

often suffer from longer manufacturing and

to confirm that manufacturing changes are not

lead times. Therefore, CGT developers should

having an adverse impact on the final product.

identify and budget for good manufacturing

Changes in methods between different phases

practices (GMP)-compliant reagents and consum-

of clinical trials - whether it is because a method

able sources early on. Leveraging CDMOs at an

is too challenging to run in a QC lab, a critical

early development stage is helpful, as they can

reagent is no longer available, or the method

establish primary and secondary suppliers of

is no longer relevant based on clinical data -

reagents and consumables. This partnership can

require lengthy and costly equivalence studies.

help CGT developers meet future demands and

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Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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