Cytiva_APR21_EarlyProcessDevDecisions - 24

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

By leveraging early decisions around process development, quality assurance, and quality control
strategies, you can set yourself up for a successful cGMP manufacturing workflow. This article will
tackle how to approach process development with a manufacturing workflow mindset that will
transition smoothly to cGMP manufacturing.

How to Design a Robust
Process for Cell Therapies
Make crucial decisions early in process development to
set yourself up for cGMP manufacturing
UNDERSTANDING ROBUST DESIGN

D

irected process development means

KEY QUESTIONS:
*	

that you focus your efforts on ensuring
that your manufacturing process is

robust. To understand robust design, you must

Will you use a manual or functionally
closed process?

*	

Will you go with single-use?

*	

Are you using a dedicated equipment

know the stage of process development when

train?

things will start to have a major impact. From a

Several factors can play in here, and the big

compliance perspective, we have a saying where

three are:

'the process is the product'. So, key decisions

*	

How fast can you get the project going?

early on will impact how you are going to accom-

*	

How much will this project cost?

plish your goals.

*	

How effective will these choices be?

It would be ideal to achieve high speed, low
Article inspired by a Tapas and TECH Talks digital event with

cost, and high quality (Fig 1). Normally, you can

insights from customer collaborations.

only have two out of the three options.

24 |

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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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