From the Editor: Lurching Toward Agility

Agility won’t come overnight, but we’re already catching glimpses of the pharmaceutical facility of the future

By Agnes Shanley, Editor in Chief

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For years now, we’ve been hearing about the need for drug manufacturing to become more agile and responsive to market changes. Yet, the agility seems a long way off. Despite all the wrenching restructuring of the past few decades, big pharma still controls roughly half a billion square feet of real estate and the industry only uses 30% to 40% of its capacity.

In this issue, we spared you from reading (and ourselves from researching and writing) a depressing capital spending report. Instead, we asked experts within the industry to share their vision of the future of pharma agility—how pharma plants will look and how they’ll be operated in 20 years. Their thoughts (read here) may surprise you.

What technologies will shape change? Disposable process technologies, wireless process control, highthroughput systems and methodologies like PAT and QbD all fi gured in the answers. Sifting through these views of the future, the following themes come through loud and clear:

  • Standardization of approaches and tools
  • Use of repeatable templates for data management and to simplify validation and construction
  • Reduction of fi nancial risk from Phase I to III—traditional approaches ask companies to freeze half a billion dollars in assets for five years in the hope that a new drug candidate will make it past Phase III testing. How many actually do?
  • Simplification and user focus
  • Lean manufacturing—Toyota practices such as OEE are starting to have more impact on facility design.
  • Green thinking and a “smaller is better” philosophy

Some of these principles are already being seen in action, in individual facilities and in platforms such as Xcellerex’s FlexFactory, a modular concept that uses disposable process equipment, enclosed “cleanrooms” (made adjustable in its latest version of the platform)around process equipment, and Lean design concepts. Studies by Jacobs Engineering have shown that FlexFactory can reduce costs for a grass roots vaccine plant from $300-$500 million to $25 million, and startup timeframes from three years to nine months.

The concept was first prototyped and demonstrated at Millennium Pharmaceuticals in 2001 and used to handle contract manufacturing when Xcellerex was established in 2003. Only this year did the company begin marketing the concept to biopharm. The company has already signed its first FlexFactory contracts, and is now discussing partnerships with engineering and construction firms. At the same time, it is developing its own drug pipeline, submitting its first IND, for a vaccine, this quarter. The company plans to move on to other new therapeutic areas in the future, according to CTO and founder Parrish Galliher.

In Singapore, meanwhile, Joseph Lam, managing director of Beacons Pharmaceuticals, plans to commercialize the Satellite Process Assurance Hub (SPAH) mini smart plant by 2011-2012. The layout, patented in the U.S. two years ago, incorporates Lean features and was designed to promote the use of process analytical technology (PAT), and better tech transfer by allowing R&D and pilot plants to be integrated. One critical piece of the agile plant puzzle is managing data. A few companies are taking a “recipe” approach to organizing data and transferring it between operations, an approach that also simplifies validation and startup. Using these approaches and newer technologies demands extra attention, and cost, on the front end, but pays off . In the final analysis, agile pharma assumes a willingness to unlearn and relearn established ways of doing things. Are you up to the challenge?

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