Cytiva_APR21_EarlyProcessDevDecisions - 25

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

But most importantly, only quality counts. If
you do it right the first time, you avoid the time
and cost involved in doing it right the second or
third time.

MANAGING VARIATION
Robust design is about managing variation.
Start with knowing your sources of variability.
The basic categories of variation are shown
in Figure 2. The circle sizes represent their

Fig 1. When developing a cell therapy process, consider how

relative contributions.

you will balance quality, speed, and cost.

The biggest impact comes from variability in
inputs, which include raw materials, labor, choice
of equipment train, and analytics.
The next biggest impact is what's going on
during the run itself, which is sometimes called
the 'black box'. This variability is dependent upon
how well the facility and equipment are running,
which is dependent upon the auxiliary support,
labor, and how experienced or well-trained the
labor force is. Lastly, the outputs are normally the
smallest variable. However, at CCRM we find that
there can be significant variability in the volume

Fig 2. The main categories for sources of variability in a cell or
gene therapy process.

Solutions for in-house plasmid
and viral vector production
Add flexible and scalable capacity rapidly
with modular manufacturing,
single-use technologies, and
Visit the
integrated automation.
webpage

GENengnews.com

| 25


https://www.cytivalifesciences.com/en/us/solutions/cell-therapy/products-and-technology/gene-therapy http://www.GENengnews.com

Cytiva_APR21_EarlyProcessDevDecisions

Table of Contents for the Digital Edition of Cytiva_APR21_EarlyProcessDevDecisions

Contents
Cytiva_APR21_EarlyProcessDevDecisions - Cover1
Cytiva_APR21_EarlyProcessDevDecisions - Cover2
Cytiva_APR21_EarlyProcessDevDecisions - Contents
Cytiva_APR21_EarlyProcessDevDecisions - 4
Cytiva_APR21_EarlyProcessDevDecisions - 5
Cytiva_APR21_EarlyProcessDevDecisions - 6
Cytiva_APR21_EarlyProcessDevDecisions - 7
Cytiva_APR21_EarlyProcessDevDecisions - 8
Cytiva_APR21_EarlyProcessDevDecisions - 9
Cytiva_APR21_EarlyProcessDevDecisions - 10
Cytiva_APR21_EarlyProcessDevDecisions - 11
Cytiva_APR21_EarlyProcessDevDecisions - 12
Cytiva_APR21_EarlyProcessDevDecisions - 13
Cytiva_APR21_EarlyProcessDevDecisions - 14
Cytiva_APR21_EarlyProcessDevDecisions - 15
Cytiva_APR21_EarlyProcessDevDecisions - 16
Cytiva_APR21_EarlyProcessDevDecisions - 17
Cytiva_APR21_EarlyProcessDevDecisions - 18
Cytiva_APR21_EarlyProcessDevDecisions - 19
Cytiva_APR21_EarlyProcessDevDecisions - 20
Cytiva_APR21_EarlyProcessDevDecisions - 21
Cytiva_APR21_EarlyProcessDevDecisions - 22
Cytiva_APR21_EarlyProcessDevDecisions - 23
Cytiva_APR21_EarlyProcessDevDecisions - 24
Cytiva_APR21_EarlyProcessDevDecisions - 25
Cytiva_APR21_EarlyProcessDevDecisions - 26
Cytiva_APR21_EarlyProcessDevDecisions - 27
Cytiva_APR21_EarlyProcessDevDecisions - 28
Cytiva_APR21_EarlyProcessDevDecisions - 29
Cytiva_APR21_EarlyProcessDevDecisions - 30
Cytiva_APR21_EarlyProcessDevDecisions - 31
Cytiva_APR21_EarlyProcessDevDecisions - 32
Cytiva_APR21_EarlyProcessDevDecisions - 33
Cytiva_APR21_EarlyProcessDevDecisions - 34
Cytiva_APR21_EarlyProcessDevDecisions - 35
Cytiva_APR21_EarlyProcessDevDecisions - 36
Cytiva_APR21_EarlyProcessDevDecisions - Cover3
Cytiva_APR21_EarlyProcessDevDecisions - Cover4
https://www.nxtbookmedia.com