APR September/October 2020 - 64

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BIOPHARMACEUTICAL DEVELOPMENT

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for the organization. A multiproduct and multiplatform cell therapy
manufacturing facility will require significant capital investment
for an organization that will be driven by the organization's overall
product portfolio. A second question that needs to be asked is how
this facility provides value to the business customers. How does this
facility streamline the overall development process and simplify
an asset's pathway to commercialization? Likewise for patients and
external customers, how does this facility focus on the aspects of
patient safety, product quality, product efficacy, on time delivery, and
cost that they care about? These questions are inherently associated
to the Operational Excellence Principle of Voice of the Customer.
Voice of the Customer focuses on what is "Critical to Quality" from the
customer's perspective, and can help identify new products/product
mixes, establishing product specifications that are meaningful to the
customer, and understand which efforts will have the most impact
on the customer. If the buildout and scale-up of a multiproduct and
multiplatform facility does not align with the overall strategic vision
for the organization or the needs of internal and external customers,
then it is appropriate to re-evaluate such facility as part of the overall
business plan. As such, an organization should first identify the
business need when building multiproduct and multiplatform cell
therapy manufacturing facilities.
A second factor that an organization should consider focuses on
the engineering and technical design of the facility. As mentioned

previously, cell therapy is relatively still within its infancy from a
pharmaceutical and biotech perspective that will continue to rapidly
evolve over the years from both a process and product perspective.
A great degree of flexibility needs to be incorporated into the facility
design to ensure that the organization can successfully manufacture
its product portfolio today as well as account for new products/
product mixes and new technology platforms. The key to addressing
this challenge for an organization is to establish a continuous feedback
loop between its functional groups with open lines of communication
to avoid silos as demonstrated in Figure 1. Communication not unlike
the Voice of the Customer concept will be key to developing a flexible
facility allowing organizations to pivot around products and platforms.
Another engineering concept that should be taken into consideration
is an organization's organic growth and the larger volumes of patients
and batches that are to be expected as an organization progresses
its product(s) through clinical development and commercial launch.
This is critical from a supply planning perspective when thinking
about drug product manufacturing slot allocation between clinical
trial drug product and commercial drug product. As such, the
overall design of the facility needs to account for this growth of
individual programs/products to avoid constraints that may inhibit
the ability to manufacture other products within the same facility. A
business should develop a five to ten year roadmap for its facility that
incorporates a facility master plan as new products/product mixes

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This webinar will provide an in-depth review of the
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asis ump and consumables
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In this webinar you'll learn:
1.

he impro ements made to reduce the chance of
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2. mpro ements made to assist with traceability
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SPEAKERS
Michel van Musschenbroek
(Presenter)
Field Marketing Mgr.
BioMonitoring- Applied Division
MilliporeSigma
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review

Who should view:
nyone currently performing Bioburden testing in their facility

Register and view at: https://bit.ly/36nS71b

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| September/October 2020

10/2/20 11:45 AM
https://bit.ly/36nS71b
APR September/October 2020

Table of Contents for the Digital Edition of APR September/October 2020
