Bioreactor Sterility Consulting
For a lot of biologics manufacturers, bioreactor contaminatons are systemic variability (common-cause). This is unfortunate since contaminations can be virtually eliminated (to the point they are the 'exception' and not the 'rule').
Folks who hire us are asking:
- How do I contain this rash of contaminations?
- How can my contamination teams be more effective?
- How can I get out of fire-fighting mode?
What are your questions?
Let's start - (with NDA)
The Initial Call - When You Call Us
No one likes admitting to having bioreactor contaminations, and frankly, when you call us, it's going to be a bit awkward:
You're going to be indicating interest in our bioreactor contamination services and trying to vet us... all while not having to say more than you absolutely must.
If you prefer, let us contact you.
On our end, we are trying to get the details of the situation (number of contaminations... bioreactor scale... contaminant morphology...etc) to see if we're a good fit, and those details are quite hard to give out without a confidentiality agreement in place.
Not to worry, though. It is bad business to go telling the world about our prospects and their problems, so you can be confident that what you disclose prior to a legally-binding NDA will not be disclosed. So the easiest way to get this process going is to sign an NDA.
Chances are, you want us onsite next week because you've been sustaining N-in-a-row contaminations and contamination mitigation efforts are in full-swing. And you think it is time to bring in fresh, but experienced, minds and eyes.
But before we get onsite, Zymergi sends consultants once we have a purchase order in hand. And a purchase order is preceded by your company's onboarding process. So in addition to the jointly-signed NDA, there are more documents... Zymergi's W-9, vendor service agreement. Perhaps a statement of work. But the faster you turn around the purchase order, the sooner we schedule travel and get onsite.
Contamination investigation reports can be read offsite. P&IDs can be read offsite. Facility tours, operator interviews and reviewing the process historian cannot. This is why the onsite time is best spent on the plant floor or reviewing trends. Sometimes, customers provide escorted access and that escort is generally a contamination technical expert.
The deliverable will vary from company to company. But things that customers have asked for in the past are:
- Statement of most probable cause
- Rank-ordered list of contamination risks
- List Immediate-term actions to address acute issues
- List of Medium-term actions for project planning
- Written assessment of status-quo bioreactor sterility program.
Our customers come in all shapes and sizes: Large-cap biotech, Medium-cap contract manufacturers. Large-cap biopharma.
We know you'd rather not have to call us. And frankly, we'd rather you not have to call us: bioreactor contaminations are stressful, political and challenging. But bioreactor sterility issues are a fact of life and if there's anyone who can mitigate that risk for you, that would be the biotech manufacturing veterans here at Zymergi.Get the NDA going
- Facility Walk-through (Gemba)Beware of experts that live only in meeting rooms.
- Review of ProceduresSOPs, Manufacturing Formulas, Work-Instructions are crucial to sterile operations.
- Review of P&ID'sIf you can't picture the sterile boundary, you can't picture the failure.
- Meeting ParticipationYes, we know sitting in on contamination investigation meetings is part of the game.
- TrainingYour people are there for the long-haul, we will imbue them with our knowledge.
- Decades of Experience Today.Onboard years of experience and skip the future headaches.
- Headcount Flexibility1099, Not W-2; No need to incur a full-time employee.
- Fresh, Veteran EyesSometimes, an outsider perspective is the right dose.