Wednesday, April 4, 2012

You Suck at Reducing Cell Culture Contaminations

zymergi bioreactor illustration
You do... you're awful. But that's why you're here.

Reducing cell culture contaminations is a big deal.

Not big... HUGE.

It's huge simply because contemporary contamination rates are typically between 5 to 15% and can skyrocket at any time.

You know what I'm talking about. You're nervously awaiting the next bioreactor contamination right now.

Chances are, you've sat through a contamination investigation meeting... NOT getting to the bottom of why your cell cultures are coming down contaminated.

You're going through the motions of a contamination response procedure that's in an SOP somewhere because it is GMP to have written procedures... and this cross-functional team of warm-bodies isn't pulling you out of this tailspin.

I mean, even if it wasn't for having to sit through crappy meetings, we're still talking about being out-of-control of a biological process. Being out-of-control means you are not GMP.

Google Genzyme and you'll see their contamination problems and the subsequent FDA beatdown.

Their Allston plant at 500 Soldiers Field Rd (right next to the Harvard Bschool) faced rampant viral contamination of their bioreactors. These contaminations temporarily shuttered their plant, left patients facing drug shortages, brought in a $175 million consent decree and crashed the stock price.

On a personal note, I interviewed for a position at the Allston plant in 1998 and got rejected; in hindsight, that rejection was one of the better things that happened for my career.

The idea is simple: stop having contaminations and the CEO-toppling domino-effect will never happen.

Easier said than done, right? Well, it starts with hiring the industry veterans that have been there and seen it. (That's what Genzyme did to remedy the situation; several former colleagues are there right now).

Not sure which veteran to hire? Read our FREE case study to see if Zymergi's contamination-reduction expert is the right guy for you.

Stop Sucking At Contaminations


No comments:

-->