46 BioPharm International eBook June 2018 www.biopharminternational.com
Single-Use Systems Bioreactors
Thorough understanding and proper
planning can result in a single-use
bioreactor capable of producing mul-
tiple drug products over many years.
Unlike conventional stainless-
steel systems, where most, if not
all, buyer-supplier relationships end
with capital equipment acceptance
or turn-over, single-use bioreac-
tor platforms and the bioreactor
bag in particular establish a per-
sistent level of engagement. New,
more durable stakeholder relation-
ships are required to maintain the
technical, commercial, and quality
aspects of the disposable bioreactor
bag lifecycle. Mutual recognition
of each party's contribution to a
successful outcome facilitates the
breakdown of pre-existing barriers
to communication and informa-
tion sharing. Open, two-way com-
munication offers an opportunity
to improve operational efficiency
through effective lifecycle manage-
ment for both buyer and supplier.
Covering more than just quanti-
ties and delivery, supply agreements
may be used to incorporate other
identified success factors, such as
cha nge ma nagement a nd inc i-
dent investigation, into a guiding
enforcement document.
In premanufacturing scales, glass
and stainless-steel bioreactor use
is widespread and often the norm.
Other than process performance-
related and technology selection
considerations, these smaller-scale
bioreactors often differ substantially
from the larger, stainless-steel pro-
duction-scale units in a number of
ways. Differences include: equipment
size, complexity, automation (mea-
surement and control), and ERP data
and document management. These
attributes are associated with "fitting,"
or integrating production bioreactors
into the facility. Customized stain-
less-steel bioreactors, using the con-
ventional approach, are specified to
custom fit each time.
Discrete, one-off designs make it
impractical for suppliers to develop
produc t plat for ms. Absence of
platform-based standard products
perpetuates a lifecycle in which
resources and time are repeatedly
expended to re-invent the prover-
bial "wheel" with each capacity
expansion. Single-use bioreactor
platforms offer an opportunity to
improve this process.
Single-use bioreactor platforms
offer consistency of form, "facil-
ity fit," and function. From process
development to production scale,
single-use bioreactors share design,
materials, components, measure-
ment and control, documentation,
and data.
Also, these product platforms
inherently alig n hardware and
bag de sig n spac e s . T he r e for e,
p r e m a n u f a c t u r i n g s c a l e s a r e
usef u l i n sor t i ng out mater ia l
biocompat ibi l it y, process f lu id
ma nagement st rateg ies, opera-
tor guidance, and data handling/
integration methods.
T he e x p a n s e o f t he d e s i g n
space(s) and the platform's mod-
ularity (8) may be used to "con-
figure" instead of custom build a
single-use bioreactor that fits the
needs of a particular biomanu-
fac t u rer 's operat ion a nd fac i l-
ity. In the search for new, more
cost-efficient, f lexible biomanu-
facturing paradigms, single-use
bioreactor platforms represent a
decisive enabling technolog y—
f rom old: cha nge t he process,
change the facility; to new: change
the process, change the bag.
REFERENCES
1. K. Clapp, "The Great Debate: Stainless
Steel Versus Single Use," https://
themedicinemaker.com/issues/0816/
the-great-debate-stainless-steel-versus-
single-use/, accessed April 4, 2018.
2. T. Deeks, BioPharm Asia (May/June),
32-36 (2017).
3. T. Deeks and K. Clapp, "Single-Use &
Stainless Steel Bioreactors: Quality
Factors for Consideration When Selecting
a Suitable System," https://biopharma-
asia.com/webinars/single-use-stainless-
steel-bioreactors-quality-factors-
consideration-selecting-suitable-system,
Webinar by Biopharma Asia, Nov. 8,
2017.
4. K.P. Clapp, A. Castan, and E.K. Lindskog,
"Upstream Processing Equipment,"
Biopharmaceutical Processing in
Development, Design, and Implementation
of Manufacturing, Processes, G.
Jagschies, E.K. Lindskog, K. Lacki, P.
Galliher, Eds. (Elsevier, Amsterdam, 1st
ed., 2017), pp. 457-476.
5. G. Gadea-Lopez and J. Maguire,
BioPharma Asia (November/December),
6-10 (2016).
6. G. Gadea-Lopez, J. Maguire, M. Maselli,
and Kenneth Clapp, "Single Use Systems
in Biologics Manufacturing and their
Impact on Operational Technology,"
https://biopharma-asia.com/webinars/
single-use-systems-in-biologics-
manufacturing-and-their-impact-on-
operational-technology, Webinar by
BioPharma Asia, April 4, 2017.
7. K. Clapp, "Single-Use Operational
Excellence Explained: Effective Lifecycle
Management," www.pharmasalmanac.
com/articles/single-use-operational-
excellence-explained-effective-lifecycle-
management, Webinar by Pharma's
Almanac, Oct. 26, 2017.
8. K Clapp, "Automation Solutions
Supporting Process Development and
Biologics Manufacturing," https://
themedicinemaker.com/issues/0816/
automation-solutions-supporting-
process-development-and-biologics-
manufacturing, Webinar by the Medicine
Maker, Oct. 10, 2017. BP
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