Furthermore, it was noted by Galliher, by identifying the optimum process components early in the development stage, biopharmaceutical
companies can eliminate the need to invest in further process development and process changes as they scale up to Phase III
clinical trials and commercial-scale manufacturing.
For larger-scale GMP manufacturing, Xcellerex is developing a modularized cell culture system that takes advantage of the
latest innovations in process control technologies and disposable components. The company has developed scaleable, disposable,
stirred tank bioreactors engineered to incorporate process sensors that monitor and control the culture conditions up to 1,000L
scale.
The system includes a manufacturing execution system (MES) that ensures compliance with SOPs, monitors the process, generates
real-time manufacturing and QC data, and supports electronic documentation.
Susan Dexter, chief business officer of Xcellerex, said the flexible manufacturing system will have significant advantages
over traditional cell culture systems. In particular, because of the use of disposables, the system eliminates the need for
plant water systems, which are costly to build and validate.
Galliher said that studies have shown that 70 to 80% of the water used in manufacturing facilities is for equipment cleaning,
and disposables reduce or eliminate that requirement. Also, the system's modularity means that Xcellerex has the ability to
run multiple processes and products in the same room.
Xcellerex will promote its new manufacturing system with what it is calling the "try-and-take" concept (the company is trademarking
the "try-and-take" label). According to Galliher and Dexter, clients will be able to have Xcellerex develop the process and
acquire and validate the flexible manufacturing module. Once the system is validated, a client will have the choice of maintaining
it at the Xcellerex facility or having the cell culture module moved to its own facility.
Whether it takes the form of expression system improvements or new equipment, it's clear that technology innovation is the
future of contract biomanufacturing. The experience of the last five years indicates that the traditional contract biomanufacturing
business model is too costly and too risky to be sustainable.
Cook Announces Biomanufacturing Entry
Not everyone is shying away from the high cost of building new cell culture capacity. Cook Group Incorporated, with the support
of state and local economic development agencies, has announced plans to start a new biomanufacturing venture. Cook will invest
$45 million to convert part of an abandoned consumer electronics manufacturing plant in Bloomington, IN, into a contract cell
culture manufacturing facility. The operation will employ up to 200 people initially.
Cook Pharmica, LLC, will be headed by Jerry Arthur. Arthur held an executive position in the former Cook Pharmaceutical Solutions,
a contract parenteral manufacturing business that Cook sold to Baxter in 2001 for $225 million. According to Arthur, the success
of that fill/finish venture encouraged Cook to look for new contract manufacturing opportunities. Cook is also an industry
leader in medical devices.
Arthur said the new cell culture facility will use stirred-tank technology and be scaled to produce phase 1 to 3 clinical
trial materials. It will incorporate single-use bag technology and a manufacturing execution system (MES) providing operators
and users real-time access to process data. Construction will be completed by mid-2005, but commercial operations will not
start until 2007.
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