Above: Advances in biopharm technologies aim to
improve facility throughput. Right: The new facility
There is one thing that is for certain as we enter the next decade of biomanufacturing; the model of product-pro- cess-facility integration is changing dramatically. The Industry is moving from a “Bigfoot” model of large scale, heavily integrated, under-utilized monsters of stainless
steel and concrete to a “Speed Racer” model focused on speed, efficiency, smaller scale, and versatility in product line capabilities.
There continues to be market pressures that include increases
in product demand, concerns about product quality,
reduced environmental impact, Cost-
of Goods (COGs) pressures, and
recent technical developments in
bioprocess unit operations that
have added significantly to the chal-
lenges of designing, building, and
operating biopharmaceutical manu-
facturing facilities in the 21st century.
A number of recent technical advances
have created valuable enabling tech-
nologies that are being implemented to
improve flexibility, reduce energy con-
sumption, decrease COGs, and increase
the throughput of the biopharmaceutical
manufacturing facility asset.
We recognize that manufacturing capa-
bility is a critical parameter for the devel-
and supply of high
quality therapeutics to the marketplace.
The first step in reaching an understanding
of future facility models is to acknowledge
the challenges presented by biopharmaceutical manufacturing advancements as
well as understanding the impact of this
As companies expand their product
pipelines, platform technologies change,
and business models have to evolve.
Many companies find themselves with
a dilemma; how to meet these changing
demands with their current, aging facility
assets. Implementation of new enabling
technologies and modular facility designs
are changing the dynamics of manufacturing project delivery as
well as those for the supply chain itself. There are a number of
companies that have established their desire to be on the lead-
ing edge of adapting these new technologies. How many others
will follow their lead?
One of the significant enhancements in bio-manufacturing that
is leading the paradigm shift is the significant improvement in
cell culture processes. These have increased cell culture yields at
least 10 fold, with another 2 to 5x improvement on the horizon.
These advances and improvements are done at the “cell molecular
factory” level through specially designed production cells systems.
These process improvements result in significantly smaller bioreactors and fewer lots required for upstream processes. These
higher upstream efficiencies have significantly reduced the volumes
required in downstream purification. Further improvements in
downstream processes will likely come from integrating downstream unit operations, higher resin loading, greater specificity and
selectivity in protein separation steps, and further improvements in
cell lines that reduce inherent impurities.
Another key enabling technology is the Single Use System
(SUS) or disposable component technology. The advantages of
One other critical enabling technology
is the automation of process and business
activities and functions. Process functions
are now being monitored and controlled
using integrated PAT (Process Analytical
Technology) and Direct Digital Control
(DDC) systems that are much more “user
friendly” and stable than the systems of the
past decade. This facilitates real-time mon-
THE PARADIGM SHIFT IN BIOMANUFACTURING
Are You Ready?
Clinical I, II