Biomedical Engineering Reference
In-Depth Information
The main driving force behind the growth of disposable systems remains
the cost benefit, despite a myriad of analyses presented in the literature with
remarkable shifts to which point of view the author subscribes to or the indus-
try sponsoring the publication. There is no dearth of what we have come to
know as “advertorials” describing new technology and its benefits. Some
companies have done better than others. A Google search for “Cultibag”
and “Wave Cellbag” returns about the same hits, around 6,000; a search for
“Xcellerex” provides about 60,000 hits. While the marketing themes may dif-
fer considerably among companies, there is no doubt that some have touted
their products too much and demanded unreasonable prices when equally
robust and much cheaper alternates are available. One of the purposes of
this topic is to point out to readers those differences.
Next to the total cost, which is significantly lower, is the attraction of timeli-
ness in the use of disposable components. Ready and available components
that require little preparation make it easier to switch over applications easily.
The newest concept is to offer a complete line of solutions as offered by all
of the major suppliers (GE Healthcare, Sartorius-Stedim, Pall, and Millipore).
Before examining the strength of this streamlined system, it would be educa-
tional to examine how Big Pharma currently plans its manufacturing systems.
A case in point is Amgen's retrofitted recombinant protein manufactur-
ing in West Greenwich, Rhode Island. Amgen invested about US$500 M to
enable manufacture of its blockbuster drug Enbrel (etanercept), whose patent
expires worldwide in 2012. Amgen's plant is now one of the biggest mam-
malian protein manufacturing plants in the world. The project involved ret-
rofitting an existing facility (the BioNow project) and the construction of an
entirely new manufacturing plant as well (the BioNext project). Both plants
use Immunex's T1 Enhanced Process developed by the Immunex Process
Science Group. Amgen uses 800,000 gallons of water per day in this facil-
ity and that has brought about a conflict with Kent County Water Authority
as an example of how these megaprojects affect both the environment and
the cost of production. The current facility includes a production building,
a warehouse, a central utility plant (47,000 ft²), and a quality laboratory. The
area covered is 500,000 ft². Also included are nine bioreactors with a capac-
ity of 20,000 L each; this is about ten times the size of bioreactors currently
used in most pharmaceutical manufacturing plants. The Kinetics Modular
Systems provided smaller bioreactors—3,000 L and 15,000 L—and the har-
vest module. The retrofit involved the adoption of 120 pieces of major equip-
ment, 25 mi of pipe, 240 mi of electrical wire, and 300 tons of heating and
cooling ducts.
The Wyeth biotechnology campus opened in September 2005 and is cur-
rently the largest in Europe. The campus, which makes Wyeth the largest
pharmaceutical employer in the Republic of Ireland with 1,370 employees,
comprises a development facility as well as a drug substance and drug pro-
duction facility, representing 1.2 million ft² in building space. The site is
