It seems to me that the KEY to reducing variations in the product output is the embedding of the analytics in the manufacturing process.
Thus, the "moronic" question produced a great answer (from transcript):
Eric Schmidt – Cowen and Company
Okay. And do you think these tools are proprietary? At one point you suggested, you had some and times that we knew, we kind of check up mixture that may be this could be at their hand or how do you think about that?
Craig Wheeler
We've been looking hard at that Citizens Petition but he also has – Let me may be step back and give you a few places to think about where – It's hard for us to say what other people have, but let me point to, where, where we think we have some particular capability and their disadvantages. Like the first, I always point to here and I’ve done it for as long as I’ve been here. This company was founded by some of the world's foremost experts and have restructured chemistry and function.
So we start off the bat with a deep understanding of the structure and where these things go. I was very pleased to see if you go back to that CP – the FDA is focused on analytical characterization. If you go back to the criteria I mentioned in my talk, criteria one and criteria three, specifically looking at busy chemical properties and in fact are building blocks, fragment mapping, (inaudible) although key apprentice. They are taking the approach that we've indicated, which is looking at multiple overlapping approaches to assure you have an equivalent product. And that probably is familiar to many of you guys have been following the company for a while.
The question, I keep getting on this is road map. In some sense it may be, but it doesn’t underestimate the complexity of this. We think we’ve build real competitive advantage here, because it's very difficult to do these types of analysis and maintain true map balance, to ensure you have all the proprietary equivalence. When we develop those approaches, we put some standards and proprietary assets that we have, some of were trade secrets, some were pathogens.
Your question on the enzymes, which is good second point – they identified the additive of the products and enzymatic, but you should to be able to do both the physic chemical characterization and the fragment mapping. We use both standard optimum short enzymes, but also proprietary enzymes that we developed and have been able to do that.
I point to one third thing, here, as well is the agencies took a lot of time if you read through that CP response and pointing out that variations and not understanding – minor variations in the process could mean significant variations in the product. And we found – we have worked at variations in the incoming heparin as well as in process conditions can actually make major variations. And they recognize that through it and so our approach from the start has been to understand these variations and take our analytics. And design them into our manufacturing processes to be able to control to make sure we make exact same product, so. Overall, I'm quite pleased with where we stand, basically what the agency has put in place and the CP response.
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)
