Manufacturing strategy was an
important factor for us. We had
grown out of our current facility,
but we were able to find a nearby
site with a large open area with
thirty foot ceilings. This area, an
“ideal box,” required minimal
demolition prior to building out
suites, and also allowed us to have
sufficient ceiling height to install
bioreactors and other equipment.
Single-use manufacturing had
evolved rapidly since 2001 and was
becoming widely accepted by our
target segment. Even though we had
six new stainless‑steel reactors, we
decided to step back and objectively
evaluate single-use technologies.
We weighed the options on both
sides. Our stainless steel reactors
were already purchased and we had
vast experience with this technology.
We also knew that our clients
tended to be adverse to change (even
positive change) because of the cautious
nature of the industry, and that
there may be concerns about transitioning
processes traditionally conducted
in stainless-steel to single-use
technologies. Most of the facility and
equipment cost savings of single‑use
equipment was nullified because of
our previous purchase of stainlesssteel
reactors. In the end, however,
we based our decision on how to
provide a better service.
Catalent’s market research
indicated that going forward,
more products will require scales
of less than 2000 L. In addition,
the research showed that companies’
acceptance of single-use systems
was significantly rising
because of the associated lower
facility and equipment costs, as
well as the reduced effort in suite
turnovers. For multiproduct facilities,
single-use systems also offer
the additional benefits of diminishing
the risk of cross contamination
and increasing throughput based on
faster changeovers.
However, there are still risks in
the adoption of a new technology
for bioreactors, such as extractables
and leachables, continued evolution
of disposable sensors, the service
of single use systems, a lack
of standardization, the challenge
to become landfill neutral, the cost
and supply chain of consumables,
and, ultimately, acceptance by our
potential customers.
To balance the risks of this new
manufacturing strategy, Catalent
consulted with experts and built
relationships with the supplier base
by seeking supplier partnerships versus
simple transactions. Additionally,
we are staying active in industry
organizations, such as the Bio-Process Systems Alliance, the ASME BioProcessing Equipment group and
PDA to help support our infrastructure
(e.g., through guidelines and
standards), and to enable us to better
understand different technologies
and trends in the market.
In early 2011, we sold our six
stainless steel reactors and made
the decision to go with single-use
reactors, mixers, and tangential flow
filtration skids. This decision was
based on aligning our business strategy
with our manufacturing capabilities.
Implementing single-use
systems enabled us to increase the
number of runs we could conduct
per year.
Ultimately, single-use systems
provide us with flexibility and
manufacturing scale to support and
solve the ongoing challenges that
companies will continue to face in
biomanufacturing.
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