Vertex Pharmaceuticals ($VRTX) is building a $30 million, 4,000-square-foot continuous manufacturing facility in Boston in anticipation that it will get approval for a new cystic fibrosis drug. It is one of a handful of projects from GlaxoSmithKline ($GSK), Novartis ($NVS), Johnson & Johnson ($JNJ) and others that are moving the industry out of its decades-old processes into a new realm in which some drugs can be manufactured without using the time-consuming, chemical heavy batch processes.
Because continuous manufacturing is new for the FDA as well as the industry, Vertex has consulted the agency from design through construction, execs told the Wall Street Journal. The agency is supportive of the moves. One of the advantages of continuous manufacturing, along with lower costs and faster production, is that quality can be monitored continuously and not only after an ingredient or medicine is complete, as with batch production. Failed batches sometimes must be discarded, an expensive proposition, that has led some drugmakers in India and elsewhere to fudge batch testing data. The FDA sees continuous manufacturing as feeding its push for higher quality drug manufacturing.
"The industry has a lot more quality and cost pressure now, so we need to transform our manufacturing paradigms," Mark Buswell, Glaxo's head of advanced manufacturing technology, told the newspaper.
Continuous manufacturing offers some real cost advantages. Plants can be much smaller and less expensive to build--$150 million less PwC tells the newspaper--and operating costs can be cut by an estimated 30%. Production is much faster from start to finish. Manufacturing exec Hayden Thomas at Vertex said that the process should allow the company to produce 100,000 tablets of the cystic fibrosis drug in an hour, rather than the 4 to 6 weeks using batch processing. That will allow Vertex to get product to the market quickly if Vertex gets its drug candidate approved this year as it hopes.
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| Bernhardt Trout |
Bernhardt Trout, Raymond F. Baddour Professor of Chemical Engineering at MIT, who has researched and promoted the techniques, recently told FiercePharmaManufacturing that 2014 was a turning point with the industry. It coalesced around the idea that it was time to embrace the new technology. But he also pointed out that it will take a long time before it will make up a significant part of the manufacturing in the industry.
Some are moving faster than others. Johnson & Johnson has a line at a plant in Puerto Rico that it hopes to have approved next year that would use continuous manufacturing for its HIV med Prezista. It plans to do much more. It wants to produce 70% of its high-volume products through continuous manufacturing within 8 years, J&J's Paul McKenzie told WSJ.
GSK is building a $29 million continuous manufacturing plant in Singapore that is slated to come online in 2016, and Amgen ($AMGN) recently announced it was using some continuous manufacturing processes in its plant in Singapore as well.
Most of the projects underway are for making finished products, not ingredients. But Markus Krumme, who heads Novartis's continuous-manufacturing unit, tells WSJ the Swiss company has a plant in Switzerland that goes the whole distance. It will manufacture a product from beginning to end.
FDA Commissioner Margaret Hamburg, who recently toured the Vertex facility, says it time for the pharmaceutical industry to move the direction that other industries did decades ago. "The pharmaceutical industry has been so slow to adopt approaches embraced by other industries, but I think the time is now," she said.
- read the WSJ story (sub. req.)