Dear friends of Xavo,

we deliver software solutions for customers from many sectors including the food, tobacco, semi-conductor, automotive and pharmaceutical industries.

Every industry has its own requirements, risks and opportunities. It’s not easy to guarantee product stability in the food industry. The raw materials come from mother nature and vary therefore seasonally.

But that’s easy compared to the cell culture production in the pharmaceutical industry. We learned the lessons with cells in our biopharmaceutical MES & Drug Discovery projects.

Cells can be a major pain. You can’t turn your back on them. Cells have to be fed. Cells can be infected. Everything we do to them is artificial, and a lot of it what we ask cultured cells to do is clearly not playing to their strengths.

One of the most successful workhorses are the CHO (Chinese Hamster Ovary) cells which produce many biologics. Currenly Genzyme is under pressure, because they’ve been having variable yield problems over the past months. Now it turns out that their production facilities are infected with Vesivirus 2117 - which interferes with CHO growth in some bioreactors, and that’s bringing Genzyme’s workflow to a halt. Fortunately the virus, a member of the calicivirus family, has not been shown to cause human infection until now.

The next step will be a complete, painstaking cleanup and decontamination in Genzym’s factories. That’s going to affect supplies of Cerezyme (imiglucarase) and Frabazyme (agalsidase) late in the summer and into the fall, although it’s not clear yet how long the outage will be. Any cell culture lab will shudder at the thought of cleaning things up on this scale.

Drug shortages were further impacted when FDA officials found that the Genzyme systems for ensuring manufacturing quality were inadequate resulting in production delays, critical shortages of medically necessary products to consumers, and drugs contaminated with metal, fiber, rubber, and glass particles.

One more reason for biopharmaceutical companies to heavily invest in water-proof MES systems which are able to avoid contaminations.  Genzyme is now learning the lessons the hard way.

Yours truly,

Detlef Riedel

P.S. „Everything is gonna be all right!”