The numbers are big enough to make the lead paragraph of a Wall Street Journal article: Genzyme has been socked with $175 million in fines on top of the $9.2 million cost of cleaning up its Boston-area bioprocessing plant following ops and QC lapses and a viral contamination. The much troubled facility, now in the midst of a $150-million renovation and expansion, recently was home to manufacturing ops for three genetic-disorder treatments: Cerezyme, Fabrazyme and Myozyme. Analysts estimate lost revenue at $1 billion.
As bad as that sounds, the Journal captured only a few of the costs Genzyme faces. Among them: high-end consultancy fees for the extended facility-rehab period; big salaries for new operations leadership; new and upgraded equipment; supplier re-negotiations; a recruitment effort to beef up operations and quality control; training for existing and new employees; PR for damage control and reputation repair. And so on.
The 1993-vintage plant had received little in the way of upgrades and preventive maintenance. Genzyme admits to taking its eye off the GMP ball: "We didn't keep up with advances in technology. Things change," according to the new operations leadership.
It is much more expensive and time-consuming to fix a broken plant than to keep it in compliance, according to the article. Most industry people know this, or could figure it out with little effort. It's not the lack of operations knowledge that got Genzyme into such hot water, but we might all thank the company for such a vivid reminder.
- here's the article