Cytiva_APR21_EarlyProcessDevDecisions - 30

Cell Therapy Process Development and Validation

platforms that require feeder layers or stimulatory

therapies, being able to measure variation within

cell lines.

a process, consistently across patients, requires

Modern scale-up strategies for CAR T cell manu-

the right analytics.
Tip: In early development, heavy characterization

facturing, specifically the expansion of suspension
T cell cultures, are very amenable to transfer into

with many measurements can help you to pinpoint

bioreactors for expansion. This allows the use of

the sources for variation and really define your CQAs

single-use equipment with closed connections,

and CPPs and their ranges. Assay acceptance criteria

preferably sterile, weldable tubing lines, as well

can also be built around these to control for consis-

as automated liquid handling and perfusion.

tent desired CQA/CPP targeted outputs.
To develop final process controls and lot

These advantages greatly lower the risk and cost
compared with manual, labor-intensive processing

release assays, you must follow regulatory

while minimizing operator manipulations.

requirements, of course, and incorporate any
specific logistical needs to your process. The ideal


state is to be able to demonstrate control and

To validate a process and achieve consistent

to have the analytics that use nondestructive

production of a biologic, you must maintain your

sampling by incorporating tools and technolo-

ranges of critical process parameters (CPPs) and

gies with in-line, real-time monitoring, wherever

critical quality attribute (CQAs) throughout the

feasible. Ultimately, if you have a flexible process

process. In order to do this the CQAs and CPPs

in which real-time monitoring allows parameters

must first carefully be defined and prioritized.1

to be adjusted, you can simplify process control
and ensure each patient batch is able to hit the

In addition to process development, minimizing variation in your process is key. For cell

target therapeutic dose and characteristics.

Solutions for in-house plasmid and
viral vector production
Add flexible and scalable capacity
rapidly with modular manufacturing,
single-use technologies, and
integrated automation.

30 |

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