Continuous manufacturing reaches a turning point

For years drug companies have been talking about continuous manufacturing, a drugmaking process that is cheaper, faster, easier on the environment, requires smaller facilities, and can be ramped up quickly in remote locations. Did we mention cheaper?

Given that the industry has hundreds of billions of dollars invested in plants that do batch manufacturing, a model that has been relatively unchanged for a century, it has been hard for the industry to commit to a new way of making drugs, even one with the potential to cut costs dramatically. But at a major conference in May, the industry coalesced around the need to adopt continuous manufacturing, said Bernhardt Trout, Raymond F. Baddour Professor of Chemical Engineering at MIT, where much of the research has been done.

"I think 2014 was a turning point with the industry coming together and saying we are going to do this," said Trout. A turning point, yes, but a pivot that will take time, he said. "Turns happen slowly in this industry."

The research at MIT focused on small molecule drugs, an area in which the barriers to entry are smaller. Instead of batches and chemical reactions, continuous manufacturing pushes raw ingredients through a series of heaters, spinners, extractors and other equipment to achieve the end result. But the process has to be factored into early development plans, and a drugmaker with 20 drugs under development can't prepare for continuous manufacturing on 20 drugs, Trout said. Still, a couple of projects look to be pioneering.

GlaxoSmithKline CEO Andrew Witty

GlaxoSmithKline ($GSK) has a continuous processing plant underway at its site in Jurong, Singapore, to make APIs for its respiratory drugs. The £19 million ($30 million) facility is slated to go online in the first quarter of 2016, a spokesperson said this week. When CEO Andrew Witty announced the project, he called it a "significant technology leap for the company." The plant is about a tenth of the size of a conventional facility and will mean a 50% reduction in cost and carbon footprint, Witty has said.

For several years, Amgen ($AMGN) CEO Robert Bradway said cryptic things about a "disruptively different" technology it was working on and "being on the cusp of a major change in how we manufacture proteins." Just weeks ago, Amgen announced it had completed a $200 million plant, also in Singapore, that would use continuous purification processing to make monoclonal antibodies, or mAbs. It took less than two years to build and occupies a single building, although it has the same capacity of a conventional plant. It will use less water and energy and produce less waste.

While a couple of plants do not make a tipping point, they mark the beginning of what some experts see as one of those "paradigm shifts" they like to talk about, a technology that will revolutionize a part of the industry that seemed stuck in the industrial age. -- Eric Palmer (email | Twitter)

Industry Voices: The future of pharma manufacturing--new disruptive technologies that can impact whole industry structures

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