Thursday, February 18, 2010

The Land of Pharma – This Old Facility

The Industry has been busy. Engineers all over the world in Pharma, in other industries, and in the Regulatory bodies have been refining old methods of production and have been creating new technologies that can see into processes to help show that everything is happening as it should. This is wonderful. But…

At our company, WMC, we have the new facility we’re creating, of which we’ve discussed at length, and we have a number of older facilities. Some of these are as ancient as 1995. Yes, dear reader, fifteen years is ancient in the Land of Pharma. Poor fella can’t even have a beer yet and already he’s past his prime. Anyway, for some time, our production processes will be grandfathered in, so to speak, because the 15 years of use has shown them to be reliable. Regulators won’t question the design because it is of an older era. For awhile… But the old factories don’t have the latest technologies – each one with the potential to take processing closer to the edge of perfection: complete process understanding.

Process understanding is, simply, knowing everything about the process. Thinking on gross terms won’t work here. This is more than knowing the inputs and outputs. We are speaking of knowing how passing material through a one foot long tube impacts the material relative to using a tube only eleven inches long. Or knowing that a 90 degree bend in a pipe increases the destruction of cells in solution by 1% more than a bend of 110 degrees. This knowledge is perfection in the Industry. And it should be, for knowing these details enables the Company to make a vaccine that is incrementally more effective and safer. And cheaper, ultimately…er, eventually, since knowledge enables decisions that can make yields go up. Would anyone argue with that progress?

But at what cost? To implement this latest technological innovation, a vaccine that is said to have saved billions of dollars in hospital costs (you don’t go to the hospital if you’re not sick in the first place) must be taken off line for three months. Is incremental understanding worth starving the market of this illness preventing vaccine? And there is one other issue: the vaccine is only available, per Regulation, to children under 12. If the vaccine isn’t available for three months, what of those children that have yet to get the vaccine but will turn 12 before the vaccine is available again?

The solution is apparent. Production must be increased to stockpile the material to cover the downtime. Running at full capacity already doesn’t make this easy. The process must be expanded first in order to increase production, then the entire thing taken down to implement the new technology, at a cost of US$33 million, all told. This is very good news for the suppliers of the machines needed and for the new workers that get good paying jobs with good benefits so the machines will run. It is also another instance of the Company needing to have many millions of dollars on hand to pay for advancements that won’t produce returns for a very long time. At the end of this, realize, that you only have more information. It will take many years for talented scientists to understand what this information really means and how to use it.

Ahhh, the sweet taste of progress.

All this, of course, while we’re still investing in our new novel vaccine plant to produce Menengvax. We’ll return to that next time.

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