Cytiva_APR21_EarlyProcessDevDecisions - 15

EARLY PROCESS DEVELOPMENT DECISIONS PAY OFF FOR CELL AND GENE THERAPIES

CONCLUSIONS
It is important for CGT developers to think about
their commercial manufacturing needs from the
outset, starting in their preclinical development
activities. CGT developers must drive the underlying biological understanding of their product,
define their target product profile, and plan their
clinical program. CDMOs can support these activThe logistical considerations of access and

ities by working in partnership, bringing comple-

shipping weigh into business decisions around

mentary knowledge and skills around process

using a centralized, regional, or local manufac-

development and manufacturing. In a quickly

turing model. This, in turn, will influence which

maturing field, CDMOs are rapidly evolving

CDMO(s) a therapeutic developer should work

as full-service partners for CGT developers by

with. The proximity of manufacturing facilities to

combining historical expertise from adjacent

clinical sites will constrain the required shelf life

industries with new tools and capabilities specific

of the CGT. For logistical reasons, frozen products

to the unique complexities of CGTs.

and frozen input cell materials are much easier

By developing a strong partnership with the

to manage and schedule. However, shipping

right CDMO at the preclinical stage, CGT devel-

cryopreserved products introduces the need for

opers can chart out a manufacturing develop-

rigorous cold chain management.

ment program that aligns with their clinical plans

Patient-specific CGTs add complexity around

and financing expectations. This ensures that

management of chain of custody throughout the

their process and analytic methods are meeting

end-to-end manufacturing process. Autologous

all stakeholder needs, from preclinical develop-

therapies also motivate the use of digital tools to

ment all the way through to commercialization.

support these needs. As the CGT field matures,

Download the Business of Biotech podcast

CDMOs are serving not only as development

series to hear from guests who turned biotherapy

experts but also as supply chain, digital manage-

ideas into clinical realities. n

ment, and logistical partners. Initiating plans early
in the development process will set CGT developers up for success through their clinical and
commercial programs.

REFERENCE
1. 	 Medvec, A. R. et al. Improved expansion and in vivo function of
patient T cells by a serum-free medium. Mol. Ther. Methods Clin.
Dev. 8, 65-74 (2017).

GENengnews.com

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Cytiva_APR21_EarlyProcessDevDecisions

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Cytiva_APR21_EarlyProcessDevDecisions - Contents
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