Cytiva_APR21_EarlyProcessDevDecisions - 3

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

TA B L E O F CO N T E N T S

Early Process Development
Decisions Pay Off for
Cell and Gene Therapies
05

MORE CELL AND GENE THERAPY FACILITIES IN
THE HUNDREDS ARE NEEDED

08

THE ROLE OF CDMOS IN CELL AND GENE THERAPY PROCESS
DEVELOPMENT
Scale-up, tech transfer, assay development, and other areas where they can help

16

CELL THERAPY MANUFACTURING TRIES
" BUILDING THE PLANE WHILE FLYING IT "
Early approvals of cell therapy products may accelerate manufacturing timelines,
which must then accommodate technology upgrades as they become available

24

29

35

HOW TO DESIGN A ROBUST PROCESS FOR CELL THERAPIES
Make crucial decisions early in process development to set yourself up for cGMP
manufacturing

CELL THERAPY PROCESS DEVELOPMENT AND VALIDATION
Options to minimize risks and prepare for successful commercial production

CELL AND GENE THERAPY SECTOR
NEEDS TO AUTOMATE

Cover: Sanjeri / Getty Images
© GEN Publishing * April 2021

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Cytiva_APR21_EarlyProcessDevDecisions

Table of Contents for the Digital Edition of Cytiva_APR21_EarlyProcessDevDecisions

Contents
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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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