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EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

Table 1. Control strategies for understanding robust design
Control element

Description

Process controls

Protocol -> SOP -> Engineering Batch Record -> GMP Batch Record
Protocol -> Developed Test method (TM) -> Qualified TM -> Validated TM

Material controls

Materials selected -> Materials qualified -> USP <1043>

Equipment controls

Equipment selected -> Equipment installed -> Qualified equipment (IQ/OQ/PQ)

Strategic decisions

Open vs closed, type of bioreactor, type of purification and selection strategy, analytical
methods

Human controls

Documented training of personnel from general to specific

Facility controls

Process development space -> Pilot plant -> Controlled manufacturing space

efficiency optimization. This should be done as early

then communicate progress to its full master

as possible, in order to take advantage of the low

batch record. Analytical methods start off with a

overall process switching costs.

very similar pathway.

CONTROL STRATEGIES
Tip: Look at closing process systems before

Tip: From your material control, select materials,
test them under feasibility, and make sure you
qualify them before you start your engineering runs.

entering Phase II. The manufacturing scientists at

Tip: For equipment control, select the right

CCRM look at projects with a goal of progressing

equipment, get that equipment installed and in

the control strategy. The six elements of the control

place, and proceed to qualification through IQ/OQ/

strategy are listed in Table 1, each with a distinct

PQ activities.

path of progress.
Processes start out with an idea on the back of
a napkin. CCRM can take that napkin, develop it

Strategic decisions are hopefully made very
early on:
*	

into a standard operating procedure (SOP), which
can then undergo more diligence through feasi-

system?
*	

bility studies. After successfully executing feasibility, we can then get ready to move into pilot

batch record. The engineering batch record can

What type of bioreactor system are you
going to use?

*	

plant, or straight into manufacturing areas, and
undergo engineering work under an engineering

Are you going with an open or a closed

What type of purification and collection
strategy will you use?

*	

Which analytical methods do you need to
measure performance?

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