Cytiva_APR21_EarlyProcessDevDecisions - 19

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

According to Fachin, automation should be

sciences in manufacturing is still at its inception,

considered and applied to all parts of cell therapy

particularly in the autologous space, " he observes.

production-processing, analytics, and data

" We are still far from having systems that allow us

management. He addresses each point in turn:

to refine the manufacturing process from lot to
lot based on the specifics of the material at hand. "

* Processing: Remove the manual operator
component and transition to fully controlled
automated operations, ensuring consistent if
not identical performance
lot to lot.
*A
 nalytics: Transition to automated highthroughput, multiparameter assays that can

Better capitalized cell therapy
companies are commissioning
significant in-house
manufacturing capabilities. "
	
-	 Anthony Davies, PhD
		 Dark Horse Consulting

be integrated in-line within the
manufacturing scheme, so as to provide

Fachin notes that Takeda has invested and

real-time information to control the

continues to invest in a vision where processing,

automated processing tools.

analytics, and data management-the " three

*D
 ata management: Transition to an infra-

pillars " -come together: " Besides immediately

structure where data can be stored and then

deploying automated process and analytical

used not only to deliver correlations with

platforms in our manufacturing processes, we are

patient outcomes, but also to provide predic-

building robotics and data infrastructure tools

tions that could enable the real-time optimi-

and expertise that we believe will eventually

zation of each product lot while it is being

enable us to deliver fully optimized, fully person-

manufactured.

alized drugs, independent of indication. "

Automation is, in fact, becoming more common

OUTSOURCING DYNAMICS

in process development and analytical method

Automation and other forms of technological

development. According to Fachin, both areas

innovation are starting to change how cell

have been the focus considerable investment and

therapies are made. However, most cell therapies

technology development. In contrast, automation

are still produced by contractors.

in data is less advanced.
" The use of big data and in-line correlative

In cell therapy manufacturing, as in industry
generally, outsourcing is used to lower costs.

GENengnews.com

| 19


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Cytiva_APR21_EarlyProcessDevDecisions

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