Cytiva_APR21_EarlyProcessDevDecisions - 28

How to Design a Robust Process for Cell Therapies

For employee controls, it is important to

because you are manufacturing one dose at a

know the trainings, which must be documented,

time, potentially. But when you get into manu-

needed to support a manufacturing lab at a

facturing for Phase I clinical studies, you might be

certain stage of development. Facility controls

making three to five, maybe ten doses. And for

are generally quite fixed. Process development

a Phase II study, you might make up to 50 doses.

work will be done in a process development

The strategy is exponentially more challenging,

space. If an employee has access to a pilot plant,

and more importantly, more expensive as you

they might have a mid-level access to the process

increase the number of doses. But it is important

controls. Full-access controls will be in place if

to think this through early on so you can set up

employees are working in a manufacturing space.

a product for success on the commercial market,

Decisions on control strategies must be timed

where you could imagine manufacturing tens of

appropriately in order to progress to the next

thousands of doses a year.

stage in process development.
When you are performing manual processes
in the R&D space, the system is manageable,

28 |

GENengnews.com

View the recorded session to learn which
control level is appropriate at what time and
access more advice.

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Cytiva_APR21_EarlyProcessDevDecisions

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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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