Cytiva_APR21_EarlyProcessDevDecisions - 32

Cell Therapy Process Development and Validation

Suite Processing manual

Key

Automated, closed Consumables

Fig 1. Predicted costs of a manual vs closed and automated cell therapy manufacturing process. This example is for MSCs based on
Lipsitz et al. Cytotherapy, 2017.

The earlier you invest in closed and

purity, and potency. With this in mind, as well as

automated processing, the easier the process

the fact that the clinical trials start with an initial

optimization will be, and the quicker tech

focus on safety, we can define the elements

transfer to start clinical trials will be. And, of

required.

course, you simplify commercial operations.

Other important aspects from the regula-

Automation allows parameters to be adjusted

tory point of view are method qualification and

through controlled and traceable digital inputs

method validation. The International Council for

in the equipment, in contrast to error-prone

Harmonisation of Technical Requirements for

manual processing. Also, fully closed processes

Pharmaceuticals for Human Use (ICH) has a good,

clearly reduce contamination risks while

rich set of guidelines. Complementing those are

allowing you more flexibility in logistics in your

the United States Pharmacopeia (USP) chapters

facility requirements.

on validation, verification, and method transfer.
If you are marketing in the US, you will definitely

QUALITY CONTROL AND RELEASE TESTING

need to review those as well as specific Food and

How do the regulators feel about the importance

Drug Administration (FDA) guidances. Table 2

of monitoring how our manufacturing processes

lists the key guidelines, and Table 3 summarizes

perform? They use specific language and termi-

the regulatory categories and activities required

nology around the identity, strength, quality,

for Phase 1 and 2.

32 |

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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
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Cytiva_APR21_EarlyProcessDevDecisions - Cover3
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