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By Jim Montague, Executive Editor
What century is this? I have to wonder sometimes. While researching and reporting this issue’s “Is PAT a Silver Bullet?” cover story, I ran smack into the fact that most pharmaceutical manufacturers apparently are years, if not decades, behind other process industries in their use of modern control and automation methods. Though some drugmakers are adopting process analytical technology (PAT), most still rely on off-line, end-of-process testing. This wastes oceans of time and money, which could be saved by designing, modeling and implementing online or at-line, closer-to-real-time testing, analysis and controls into their applications.
Now, I’m well-versed in control and automation’s “if it’s not broke, don’t fix it” mantra, but this is beyond ridiculous. I’m sorry to say it, but this situation reminds me of the surgeons in the 19th century, who long resisted washing their hands before operations because they didn’t believe in the germs that were killing many of their patients.
At the same time, despite pharmaceutical manufacturers’ immense R&D facilities, I also remembered that most drugs still are discovered largely by accident, often as observed side effects of other medications. Likewise, I was reminded that many drugs remain unsophisticated enough that they still affect different people in different ways. For example, a recent PBS’ Frontline documentary, “The Medicated Child,” reported that drugs for bipolar patients had little effect on children.
All of these factors make me question if any aspect of pharmaceuticals from production to consumption is running efficiently? When viewed collectively, it seems a veneer of precision is peeling away from pharmaceuticals to reveal an industry that is far more Wild West than most people realize or will acknowledge.
Unfortunately, many pharmaceutical firms often claim that implementing process control and PAT is stifled by too-burdensome validation requirements imposed by the FDA. However, these rationalizations started to ring hollow after the FDA granted drug companies new freedoms and “design spaces” about four years ago. These PAT guidelines allow manufacturers to alter some process parameters without revalidation, but few have made substantive changes, and most are still exploring what to do.
“Validation requirements haven’t helped, but they’re not a primary problem, and they’ll become less of a problem as regulators adapt existing validation approaches,” says Gawayne Mahboubian-Jones, product development manager at Optimal Industrial Automation, a U.K.-based PAT system integrator. “However, high profit margins have two negative effects. First, they make people misjudge what needs to be achieved and how much change is required. Second, they make those at board level reluctant to take perceived risks when they’re making good profits. This is a form of ‘short-termism’ that’s actually blindness to long-term needs.”
So once again, it’s about the money. Rather than encouraging action, readily available financial disincentives strangle innovation and efficiency. In physics, a body in motion tends to stay in motion, but a sociological corollary might be that a well-fed body tends to stay motionless on the couch. Like over-watered houseplants, our too-well-nourished hunter-gatherer physiologies tend to bloat, wither and die when unused.
Consequently, pharmaceutical manufacturers need to hurry up adopt the FDA’s PAT guidelines and implement the control and automation efficiencies achieved by specialty chemical and other process industries during the past 20-30 years. And process control and automation engineers need to help because those same aging engineers, a few million sagging Baby Boomers and I are really going to need those inexpensive medicines soon.
Unrestrained prosperity is a disease, so it’s tragic that drug manufacturers don’t want to take their medicine. Just like the rest of us.
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