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By Emil W. Ciurczak, Contributing Editor
I fear that some of my recent columns have made me seem Andy Rooney-ish, more than a bit pessimistic. Some of this may be due to the fact that I came of age in the 1960s: “What do we want?” “______!” “When do we want it?” “Now!”
I’ve become so vested in the ideas of PAT and QbD that I assumed that merely discussing their logic would immediately convert everyone. Now, I’m re-evaluating my timetable for the industry’s acceptance of PAT and QbD.
Assuming that all good ideas eventually take root, I will now look for positive signs. One strong sign is the number of hardware breakthroughs for analysis of almost everything. In a session I chaired at the EAS (Eastern Analytical Symposium) in November, John Coates (Coates Consulting) shared a number of small, hardened, and versatile instruments for real-time analyses. It was a thrill to see saltshaker-sized spectrometers, costing less than my 1965 Chevy.
When I speak about applying PAT or QbD with decision-makers in the industry, one of the very first questions is almost always, “What will it cost?” I may have been a bit harsh in saying that they had to spend to save. That logic applies to every aspect of life; but, sometimes it isn’t possible. It is better (financially) to own a house than rent. But, if you don’t have money for a downpayment, you keep renting. In light of the mergers and massive downsizings, money is not exactly pouring from the company coffers.
It is more than difficult to ask for a million dollars and to tie up a large number of trained personnel while simultaneously asking some of the same ilk of scientists to pack up their tents and leave. (I read that something like 86,000 people were let go by pharma companies in 2009, as of the end of October.) There are two ways to settle the question of “PAT or no PAT?” We can simply continue to shrink the payroll and shut down plants and R&D facilities or find ways to lower the cost of modernizing our production control/analysis.
Here’s the light at the end of the tunnel: if even 1/10th of the instruments I am seeing come to market as working models, the cost of monitoring an entire production line could, conceivably, cost less than a single hardened analyzer today. So, a little instrument could start a mini-revolution: first, the cost of measuring a process falls, allowing for better process control, which lowers the cost of producing (better) product, which then slows the closing of plants, which allows management to allot more assets to PAT/QbD, which makes better/cheaper products, and the circle closes.
Add to this the fact that more and more colleges are offering courses in process analyses and control and there’s more to cheer me up. It would be proper to point out that if PAT were cheap and easy, it would be ubiquitous already.
Another glimmer was a comment by an acquaintance that his family’s company in India had to outsource to China to meet costs. That implies that (slowly) the standard of living in India is rising. And, as a corollary, as more and more production is sent to China, that country will need to educate more and more workers. Along with this, the Chinese wage structure will need to change to compensate the better educated workers. All this will lead to a higher standard of living in China.
What’s the good news for the U.S.? As it becomes more expensive to run a plant (using the “good old” methodology) in China and becomes less expensive to update a process line in the U.S., using the new miniature instruments, the more companies will stay here and stabilize. This will all result in a stable and increasing job picture, coupled with better (safer) and less expensive products.
So, now that we are in the second decade of the 21st century, there is hope that the pharmaceutical industry will move out of the fifth decade of the twentieth century. Thus, I have seen glimmers of hope and shared them with you. (You want warm and fuzzy on a regular basis? Read Readers Digest. I live in the pharma world.)
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