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This article discusses options for cell therapy process development and validation that minimize
risks through quality control (QC), optimization, scaling, closing, automation, and assay
development, all in order to prepare for successful commercial production.

Cell Therapy Process
Development and Validation
Options to minimize risks and prepare for successful
commercial production
o achieve commercial success, a


desirable. This can be done with low cell volumes,
starting with batch feeding, and then ramping up

developed process must be scalable and

feed and waste production rates with perfusion

suitable for a manufacturing environ-

to progressively expand cells. Also, in contrast,

ment. The scaling strategy depends on the type

autologous cell therapies are personalized for

of cell therapy. Allogeneic therapies are meant

each patient, so the batch sizes are small. Autol-

to serve many patients. This scaling strategy of

ogous therapies use a scale-out strategy, where

traditional bioprocessing, such as monoclonal

additional small bioreactors are added to increase

antibody therapy processes, commonly uses

production throughput.

a seed-train approach, where you scale across

Allogeneic processes can be optimized at

systems, progressively increasing in size. For allo-

scales from 100 mL to 2 L, and volumes up to 25

geneic cell therapies, in order to minimize sterility

L can be achieved in Cytiva's Xuri rocking biore-

and handling risks in more precious patient-de-

actors. Very large batch needs up to 2000 L can

rived cells, scaling within the same system is

be met in Cytiva's Xcellerex line of stirred-tank
bioreactors. For autologous processes, the 0.5 to

Article inspired by a Tapas and TECH Talks digital event with
insights from customer collaborations. Experts were from
Cytiva and CCRM.

5 L volume range is usually enough. Large-scale
bioreactors can be used for other immunotherapy

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Table of Contents for the Digital Edition of Cytiva_APR21_EarlyProcessDevDecisions

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