Contract Manufacturing / Facilty Design & Management

From the Editor: A New World Order

Fundamental innovations in manufacturing will determine who survives.

By Agnes Shanley, Editor in Chief

The last decade has seen the meteoric rise of strategic drug manufacturing hubs on three major continents: Puerto Rico in the Americas, Ireland in Europe, and Singapore in Asia. Pharma microcosms, each of these centers directly employs roughly 30,000 people in some aspect of drug manufacturing or research.

Each was built on a foundation of economic incentives such as tax breaks. Each is now moving beyond manufacturing and building a knowledge base for its life science industries. Ireland plans to focus on “high growth” ventures that, over the next few years, will add billions of dollars to its economy, while Puerto Rico is moving full speed ahead into drug development and clinical trials.

Both Ireland and Puerto Rico are watching warily as India and China build GxP research and manufacturing capabilities. They’re not alone. The sheer scale of India’s and China’s potential life sciences businesses has scared many in the U.S. and Europe. And it’s interesting to note the defensiveness in many responses to it — almost a “GMP snobbery.” “Yes, but we will maintain the lead in quality and innovation” is the typical response.

Well, “we” won’t maintain that lead forever. In some areas of innovation, we may already have lost our edge; India and China are now the world’s leading suppliers of APIs (read Girish Malhotra’s column for more on this). And both nations are dead serious about meeting FDA standards.

And yes, we have MIT and Purdue, but then consider the strength of India’s universities, particularly the Indian Institute of Technology, whose graduates lead a number of major corporations the world over. ISPE has already recognized India’s importance by establishing a base there, adding to its efforts in Europe.

How will higher cost nations be able to compete in the industry of the future? One way is by developing technologies that will advance drug manufacturing and reduce costs.

Consider some of the work under way in Ireland, an excellent but still a relatively expensive place to start a pharmaceutical company. Manufacturers based in Ireland have embraced transformative technology and are investing in it.

One result is the Center for Bioanalytical Sciences, which will start in September, with over $10 million in funding from Bristol-Myers Squibb Co., and involve top researchers from Dublin City University and the National University of Ireland in Galway.

The Center is addressing issues at the heart of biopharmaceutical manufacturing — the issues that prevent the biotech industry from reaching its potential, that prevent Process Analytical Technologies (PAT) from being applied to many biotech processes, and that keep processes complicated and products expensive. Through five different projects, the Center will develop the knowledge required to allow true process analytics, online or otherwise, to be applied to complex bioprocesses. All told, BMS estimates, these technologies could reduce the costs required to run a typical medium to large-scale biopharmaceutical manufacturing line by $50 to $80 million per year.

Different projects will attack areas such as characterizing feed materials before, during and after mixing, to allow better control of fermentation processes. Others will focus on developing rapid, real-time methods for tracking biomolecules during cell culturing.

This is fundamentally important research, whose benefits promise to extend far beyond BMS, and benefit biotechnology companies of all types in all countries. In fact, the contract has been set up so that the universities will be free to develop any intellectual property that results.

It’s projects like these, wherever they are based, that will enable local life sciences industries to thrive and grow. The Center is looking for a few good people — not only two Chairs (www.dcu.ie/vacancies/080705a.pdf) but experts in bioanalytics, bioengineering and biotech are already being actively recruited.

Have you worked abroad or thought of working in a drug facility in another part of the world? Manufacturers could end stereotypes and develop a truly global industry by encouraging employees---not just top scientific and management talent----but people at every level of the organization, to spend some time working in a sister facility in another country. What do you think?

Please e-mail responses to ashanley@putman.net. We appreciate your feedback!

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