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Are Disposable BioPharmaceutical Factories The Model Of The Future?

Oct 09, 2013



GE reportedly building disposable drug factory for China site.


Disposable diapers, disposable syringes, disposable cameras, contact lenses, cell phones, food containers, cups, plates, cutlery, razors, (paper) towels, mops, batteries, water bottles, lighters, rocket boosters; the list seems endless. Some of these items are understandable, such as rocket boosters, many can be replaced by reusable items, refillable water bottles and rechargeable batteries for example. Some are for convenience and possibly excusable at times, disposable eating items at an impromptu gathering for example. Some, such as disposable syringes, are chosen because they reduce company liability in addition to other benefits. Some are desirable, disposable income jumps to the top of the list. But what does it mean to build a disposable factory?

According to the website BioPharmaReporter.com manufacturing giant General Electric is planning to build just such a project for JHL Biotech to be located at a site in China. (Link to Source)  What is this about and why disposable?

Introduced in late 2012, GE’s Healthcare announced KUBio™, a 1200m2 pre-fabricated modular facility “delivered with a complete ready-to-use production line, based on GE Healthcare’s Ready-to-Process™ single-use technologies.” (Link to Source) The company’s website shows design images of the plant with its Spartan exterior and an interior dedicated to cGMP (Current Good Manufacturing Practices) manufacturing. The company boasts using the off-the-shelf design as a way manufacturers can bring manufacturing of biopharmaceuticals such as antibodies on line quickly, in 14 to 18 months including planning, delivery and construction. This compares to the traditional 24 to 36 months for traditional designs, and speeds time to market at a lower capital cost according to GE.

GE Healthcare's KUBio  (Graphic: Business Wire)GE Healthcare's KUBio  (Graphic: Business Wire) 

Exterior and Modular Interior of GE’s KUBio Single Purpose BioPharmaceutical Factory (Link to Source)

GE will pre-build the plant’s modules in Germany under cGMP specifications and deliver it to JHL’s site in the Biolake Science Park in central China’s most populous city, Wuhan. 

GE KUBio 01GE KUBio 01

 

Left: Wuhan Biolake Industrial Park (Link to Source), Right: Interior of KUBio Module (Link to Source)

The modular trend is not new. Aside from modular offices used at construction sites and modular classrooms for schools, other industries have adopted the trend. Most recently modular data centers have garnered much press. Preloaded server and facility modules can be delivered and interconnected quickly to shorten time to market. Some data centers these days look like cargo transport containers stacked in desert or remote locations so long as high speed telecommunication lines and electricity are available. Back in the BioPharmaceutical world, German based Sartorius has been promoting its disposable reactor designs that, while not a complete turnkey facility, provides a ready to use production capability comes ready for six distinct processes. (Link to Source)

imageimage

Left: Sartorius FlexAct® CH disposable cell harvesting Biopharmaceutical processing modules (Link to Source ); Right: Microsoft’s Preassembled Components Module contain air handling and IT components (servers, etc.) ready to plug into Data Center facilities. (Link to Source)

One question remains. How cost effective are modular BioPharmaceutical factories in the long run? Because they are single purpose, when the material manufactured at the plant is no longer needed, is the factory truly disposable. If yes, what does that do to the cost of acquisition and site preparation capital?  Data center technology is generally outdated in three years, five tops for leading edge companies and financial institutions, so disposability is planned. And modules can be delivered wholesale to replace outdated modules. The outdated modules may be just fine for less demanding industries so long as the original owner is assured all data is purged. The same may not be said for single purpose reactors which in some cases may be contaminated with proprietary materials. Images of Walt and Jesse disposing of their RV meth lab after the DEA is closing in on them come to mind from the TV series Breaking Bad.


Breaking Bad RV  Breaking Bad RV

Breaking Bad Images - Left: RV Meth Lab (Link to Source);  Right: Disposable Lab? (Link to Source)

BioPharmaceutical manufacturers will need to assess the value of time to market and depreciation of “disposable” factories to determine if the single-purpose modular factory model is right for their business.  Watching GE’s KUBio developments and the experience of JHL Biotech in China may help determine the answer. Ultimately companies will need to rely on their understanding of the market as well as a reasonable RoI analysis to make the best decision.

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