Tuesday, April 23, 2013

Are You Seeing An Uptick in Bioreactor Contaminations?

There's been an uptick in the number of requests we're seeing from biotech manufacturers regarding our bioreactor sterility services.

A lot of new biotech manufacturers have questions like:
  • What is everyone else's contamination rate?
  • What's a good benchmark to target?
  • What are "low-hanging-fruit" items I can work on now?
The reality of [bioreactor] contamination response is that it can be un-scientific. And the reason it's hard to be scientific about responding to contamination is because losing run slots can be emotional.

If you're reading this wonkish blog, you know what I'm talking about. The first thing is that there's a lot of work that went into a contaminated batch and all that work is wasted. It's demoralizing. Not meeting campaign goals may disrupt supply of your API. Patients may not get medicine. And worst of all, you might get sucked into convening a contamination investigation.

As an employee, I've sat in on innumerable contamination responses. And when we've brought in outside consultants, we were in crisis mode. These guys are generally pretty good at helping everyone keep calm and help people walk through whatever system of thinking:
  • Kepner-Tregoe
  • Six-Sigma (DMAIC)
  • 5 Why's
These guys are usually generalists, and that's fine. A lot of times, applying a problem-solving system will help get the emotions out and the science back into contamination response. And if you're a big biotech, there's the perception that you have all the experience in-house and it's a matter of applying the resources properly.

The reason we offer biotech veterans is because large-scale sterility operating principles get lost through the years. A lot of companies operate off tribal knowledge. There's that one guy that's been there for 25-years and he's about to retire. Or that your memorandums are stuck on some share drive (or worse, LiveLink or SharePoint) where you can't find them.

Sometimes, good sterility practices are coded into the automation or written into SOPs and the reason for these changes are stuck in the change-control system where most people can't get to it. Institutional knowledge gets fragmented and lost through the years.

This is why we offer biotech veterans for contamination responses.  We will deliver:
  • Statement of Most Probable Cause (MPC) of acute contaminations
  • Rank-ordered list of sterility risks
  • Summary/Assessment of operations
With this report, you get both action to actually solve the problem. And you get perceived action to help you "manage up."

So whether your a new Korean CMO or NJ Biopharma, the big question is: can you afford to wait until crisis mode before bringing in veteran contamination consultant?

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