There has been a rising demand for biologic
compounds in recent years, but biomanufacturing
processes have met this challenge
through technology, innovation, and
hard work. Many of the changes that have
taken place in biomanufacturing have been step
changes. For example, as biomanufacturing has
shifted from unmodified organisms, such as plants
and pigs, to recombinant cells grown in bioreactors,
expression levels have increased from milligrams
per liter to grams per liter. This expression
increase, however, has resulted in many facilities
having mismatched upstream and downstream
capacities. Companies that implemented new manufacturing
strategies to adjust and adapt to changing
processes have been able to provide reliably
sourced products, while those companies that miscalculated
demands and capacities have become
acquisition targets.
By the end of 2010, Catalent had grown out of its current manufacturing facility. After identifying a new location,
the company began to evaluate single-use systems, which have received growing acceptance in the biopharmaceutical manufacturing
industry because of the associated lower facility and equipment costs, as well as the reduced effort in suite turnovers.
Catalent had recently purchased six new stainless-steel reactors and also had experience with this technology. However, after
consulting with experts, the ultimate choice was made to sell the stainless-steel reactors and to go with single-use reactors,
mixers, and tangential flow filtration skids. To aid successful implementation, the company built relationships with the
supplier base by seeking supplier partnerships versus simple transactions. The decision was based on aligning
business strategy with manufacturing capabilities. Implementing single-use systems enabled the company to increase the number
of
runs it could conduct per year.
Case study
The emergence of single-use technologies
is one of the key changes
that has impacted biopharmaceutical
manufacturing. In 2010,
Catalent faced the decision as to
whether to adopt single-use technologies
or to continue with traditional
stainless-steel operations.
In 2001, we transitioned from
a bovine transgenic company to
instead focus on mammalian cell
line engineering and manufacturing.
Our GPEx mammalian expression
technology provides short
timelines and stable production of
biopharmaceutical proteins, and
can provide a master cell bank candidate
in around 4.5 months. To
help launch the technology, we
built our first cGMP facility, which
comprised two 100L noncGMP
stainless steel reactors and two
200 L cGMP bioreactor trains. As
the technology became more well
established and utilized within
the biopharmaceutical industry,
we sought to expand the cGMP
space. In 2008, we purchased six
new stainless‑steel reactors (two
100 L bioreactors, and 200 L, 500 L,
1000 L, and 2500 L bioreactors).
With the economic conditions deteriorating
at the time, however, our
expansion strategy was postponed.
The economic downturn changed
the dynamics of the market and
venture capital markets slowed, but
our expression technology was in
high demand because of the time
savings it offered in bringing new
products to the clinic; particularly
for small- to mid-sized biologics
companies who were carefully monitoring
their cash flows. By the end
of 2010, we were nearing full capacity
so we revisited our expansion
plans.
