Cytiva_APR21_EarlyProcessDevDecisions - 31

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

PROCESS DEVELOPMENT DECISIONS

get through clinical trials. We highly recommend

Table 1 summarizes the key options to consider

closing and automating your manufacturing

when developing commercial-scale manufac-

process. Different processes have different needs,

turing of a CAR T cell process.

and solutions need to be tailored to suit and
balance the required costs and timeline. Cytiva's

Each process development aspect has
different benefits that may drive your focus areas.

Fast Trak process development services can help

Larger investments in process development can

you to implement best practices in areas where

increase your chances for commercial produc-

you want to focus.

tion successes, and many of these benefits also

Figure 1 represents a cost savings prediction

imply a reduction in cost of goods (COGs). But

for mesenchymal stem cells (MSCs), if you were to

ultimately, this must be balanced with the race to

fully close and fully automate the process.2

Table 1. Main decisions for CAR T cell manufacturing at commercial scale
PD focus area

Best practices

Benefits
Product
development

Raw material
selection

GMP reagents and media
formulation screening

x

Define ancillary reagents

x

Obsolete poorly defined raw
materials

x

Identify supplier sourcing
with backups
Define input cell source
selection and availability

MFG operations

Process
variability

x

x
x

x

Production risk

x

Regulatory
burden

x
x

x

x

x

x
x

Optimize T cell enrichment
Cell or gene
input material and isolation strategies
Viral vector selection and
titer optimization

Final process

x

x

x

x

x

x

x

SOP generation with built-in
unit op tolerances

x

Engineering runs with
integrated unit ops

x

Tech transfer to CMO for
process validation

x

x

Process validation activities

x

x

x

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Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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