Cytiva_APR21_EarlyProcessDevDecisions - 4

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

INTRODUCTION

T

he number of cell and gene therapies

As techniques and technologies are advancing

(CGTs) entering clinical development

so quickly in cell and gene therapy manufac-

has increased significantly in recent

turing, embracing innovation is critical. Most

years. However, the surge in clinical activity has

cell therapies still use risky and expensive open,

not been matched by an increase in produc-

manual processes. The goal is to move towards

tion capacity. Cell and gene therapy manufac-

closed and automated equipment in order to

turing is still a young industry and Biopharma

lower manufacturing costs and risk, as well as

companies are still figuring out what a standard

modernizing to meet regulatory and supply

production facility should look like for these

demands. Automating expensive manual steps

novel biotherapeutics.

also has the advantage of removing manual

In order to help make manufacturing more
efficient and cost-effective, it is important to

processing variability.
These complex issues surrounding CTG

consider building for flexibility and multipurpose

development and manufacturing led Cytiva to

manufacturing from the outset. This is particu-

develop services and solutions that support

larly important in case of early product approval,

process development, scaling and automation.

which can give manufacturers little time to hone

These combined offerings help focus efforts

their production processes, resulting in expensive

on ensuring that manufacturing processes

large-scale manufacturing and increasing

are robust, combining more than 25 years of

product cost. More and more companies are now

development and manufacturing experience in

relying on contract development and manu-

bioprocessing.

facturing organizations (CDMOs) to guide their

This collection of articles focuses on the need

development process, avoid pitfalls and prevent

for making crucial decisions early in process

delays in time to market. CDMOs are rapidly

development in order to minimize risk, cost,

evolving as full-service partners for CGT devel-

product variability and time to market.

opers by combining historical expertise from
adjacent industries with new tools and capabilities specific to the complexities of CGTs.

4|

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Cytiva_APR21_EarlyProcessDevDecisions

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Contents
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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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