You may never have considered this, but pharmaceutical manufacturing and professional football have a core similarity. No,
this is not Tuesday-morning delirium from someone who stayed up too late watching Monday Night Football. And I'm not saying
that validation managers have multimillion dollar contracts, or that the process development and manufacturing teams celebrate
their successful tech transfers by pouring a cooler of Gatorade over the senior manager's head. Nor am I suggesting that the
3–4 defense is a good strategy to apply to downstream processing.
What football and bioprocessing have in common is that in both cases, success is a minimum requirement. Bill Parcells, one
of the most successful coaches in the history of the NFL, captured this perfectly when he said, "There is winning and there
What Parcells is alluding to is not just the torture of losing for the highly competitive people who play or coach professional
sports, but also the pressure of expectations. When you win consistently, everyone—the media, the fans, the team owners—starts
to think that it's easy for you. You win another game, and they don't give it a second thought. They don't appreciate it.
For manufacturing, of course, it's even worse, because unlike football, where at least a big win can be the subject of endless
television coverage and water-cooler conversation, manufacturing success rarely gets noticed. The CEO doesn't stop by to say
"Hey, nice execution on those batch records." The local TV reporter doesn't put a microphone in front of the director of process
development and ask, "How did you achieve such tight process control?"
When problems arise, however, it's another story. Of course, on the gridiron or the plant floor, a few things can go wrong
along the way without excessive criticism—a missed tackle, a sack, an interception (an out-of-specification result, a deviation
inspection, even a discarded lot)—as long as the end result is positive: another "W" on the record (only high quality product
gets released). But when actual games are lost, or warning letters arrive, the scrutiny begins.
In football: Do they have the right defensive scheme? Their undersized offensive line can't protect the quarterback. And their execution
is so sloppy. Why do they commit so many penalties?
In manufacturing: Do they have a good downstream processing scheme? Maybe they didn't design their scale-up studies properly. And the operators
must not be following SOPs. Otherwise, why do they keep getting so many 483s?
In drug manufacturing, of course, errors can cause more than just disappointment. Patients' lives and wellbeing are at stake,
which is why quality is paramount. What is less recognized, however, is that the company's financial health also depends on
manufacturing. A consent decree can involve millions of dollars in fines. A plant shutdown can cause drug shortages that can
lead to long-term market share loss, as patients switch to, and continue with, a competitor's drug. Either situation can lead
to lost investor confidence, declining stock prices, or even a failed start-up company. That brings up another Parcells quote:
"Success is never final, but failure can be."
So even though fan expectations about football may be overblown, excellence really has to be a minimum requirement in drug manufacturing. Given those high stakes, then, it would be nice if the larger world acknowledged
the everyday successes of those who make sure that the manufacturing department keeps on winning, week after week. Because
clearly, failure is not an option, even if there is no Super Bowl glory at the end.
Laura Bush is the editor in chief of BioPharm International, firstname.lastname@example.org