The problem with good manufacturing practices is business. Genzyme tells the Wall Street Journal that it skimped on preventive maintenance and other quality control measures due to production demands, which stemmed from the early approval of a drug, catching the company off guard. It had to begin commercial production at its 15-year-old facility already producing two other drugs.
That's not the whole story, of course. Aging bioprocessing equipment and outdated processes reach a relatively early point of no return, compared with those of small molecule drug manufacturing. "You might as well throw away everything you have and start from scratch," says a WSJ source.
To that the FDA would likely agree, though you won't find it spelled out in industry guidance documents. Once the regulator smells trouble at a facility, it circles the prey, watching for missteps in promised fixes. Such missteps often occur in plants having older technology and processes, which may be not just difficult to upgrade but even then still inferior to newer technology which unavoidably filters into the FDA's thinking. And lately, the regulator has grown impatient with transgressions in required manufacturing processes that are documented and known. It's no longer the young cat honing its hunting skills, playing with its prey for the practice and sheer fun of it. This is an older, no-nonsense cat that eats when it's hungry.
In light of production constraints, Genzyme skimped on preventive maintenance and other QC measures, admits manufacturing chief Scott Canute, in the article. And few upgrades had been made to the plant, built in 1993. "We didn't keep up with advances in technology. Things change," says Ron Branning, head of global quality.
In Genzyme's case, a drop in productivity signaled its manufacturing decline, though the significance of the metric appears not to have been understood. That's likely an executive-level lack of understanding, rather than an ops-level one. By background and training, Henri Termeer knows better. But the rarified air of the executive suite, metabolized for too long, has its effect. Biopharma business success comes with competitive pressures that can compromise sound decision-making.
The Genzyme case attracts Monday-morning manufacturing quarterbacks. That's in large part because the company has been publicly forthcoming in its response to its troubles. Termeer himself answers operations questions during investor calls, accepting responsibility and moving both the fixes and the conversation forward. Details are posted in press releases on the company Internet site. Even the Wall Street Journal article, with the access Genzyme granted the reporter to operations leadership, shows Termeer may view transparency as perhaps his best bet for regaining trust among shareholders, regulators and the drug-taking public.
Chances are, both Termeer and the Monday-morning quarterbacks will agree on one thing: the currently outraged shareholders would likely have expressed just a different kind of outrage a few years ago had Termeer proposed budgets containing the manufacturing investments required to stay ahead of the bioprocessing operations curve.
- see the WSJ article