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The FDA Wants Pharma to Ditch its Archaic Drug Making Process

April 14, 2016, 8:52 PM UTC
Inside of a Gilead Sciences Lab
Darryl Kato, research scientist for Gilead Sciences Inc., works on the synthesis of a potential hepatitis C virus drug candidate at the company's lab in Foster City, California, U.S., on Wednesday, Feb. 8, 2012. Gilead acquired Pharmasset Inc. last month for its experimental hepatitis C treatments as it aims to compete with other drugmakers like Bristol-Myers Squibb Co. and Merck & Co. to develop a new class of oral cures for hepatitis C to replace older drugs that require injections. Photographer: David Paul Morris/Bloomberg via Getty Images
Photograph by David Paul Morris — Bloomberg via Getty Images

The process of biopharmaceutical drug manufacturing is stuck in the past. And the Food and Drug Administration (FDA) is now openly calling for drugmakers to spring it forward into the 21st century.

In an FDA blog post from earlier this week, Dr. Lawrence Yu compared the predominant “batch” manufacturing technique used by the industry to an archaic relic, particularly in the era of biotech therapies.

If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant of today, it might be surprising to learn that they would already be very familiar with most of the processes and production techniques being used,” he wrote. “That’s because not much has changed in pharmaceutical production over the last 50 or so years.”

As in other industries, batch manufacturing in pharma involves regular breaks between spurts of production. Continuous manufacturing (as the name suggests) is usually a persistent, unbroken process wherein production plants keep humming.

Batch production is saddled with several disadvantages. For one, it’s significantly more time-intensive and less efficient (Yu says that a month of batch production could be compressed to as little as a single day with continuous techniques). More significantly, it can also be a threat to consumers’ well-being. “[S]peed alone would not matter if continuous manufacturing compromised quality,” wrote Yu. “But…continuous manufacturing is more reliable—and safer. That’s a powerful combination.”

The FDA’s post comes on the heels of the agency’s pioneering decision last week to approve Johnson & Johnson (JNJ) biotech arm Janssen’s request to switch over from batch to continuous manufacturing for the production of the HIV drug Prezista. And now, regulators are declaring outright that other biopharma players should “consider similar efforts.”