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By Emil W. Ciurczak, Chief Technical Officer, Cadrai Group
|The proximity of the FDA's offices and the involvement of FDA personnel in this year's and other recent IFPAC meetings has had a notably positive effect on the overall program.|
This is the third year that the conference has been within shouting distance of the FDA’s sites in the Washington, D.C., area. The proximity and involvement of FDA personnel have greatly impacted the program (and I could drive from New York and save a few Euros). There were sessions — often three, four or five — happening simultaneously, every day. I cannot remember a meeting where I was so stretched. Many other conferences, it is difficult to find ANY session worth attending, let alone several. I will attempt to break down the proceedings into logical packets. But there were so many things to see…
It was an exercise is being in six rooms at a time to try to see all the presentations I wanted to attend. There were, of course, basic “What is PAT?” talks for the beginners in the crowd to go with some pretty detailed talks for those well into PAT.
The Tuesday plenary sessions were a mix of basic primer and “meat.” All industries were included, but the strong presence of the FDA was apparent. Jeff Gunnell and Bill Floyd represented ExxonMobil quite well. And it is apparent that petrochemicals (as well as most other industries) are well ahead of pharmaceutical companies when it comes to process control. While it might be said that potato chips and gasoline are not potent drugs (except that our President [Carter, wasn’t it?] said we are “addicted to oil”), we recognize that more than caution is involved.
Tim Moore (Genentech) had some pretty salient comments on biotech manufacturing; however, much of the talk was on what they will be doing. Several talks were included on Homeland Security (Laura Skubal, Argonne National Lab and Quentin Saulter, ONR) and were testimony of how versatile the instrumentation of process control can be. In addition, if there are government monies driving the development of new instrumentation, we will all benefit, in the long run. Remember the moon landings and Velcro and Tang?
As usual, Ajaz Hussain (Sandoz) had a lot to say. His enthusiasm has not diminished a whit since moving from government to industry. His “quality by design” campaign encompassed everyday medicines through the (potential) bird flu pandemic. However, he didn’t include many specific actions in his department. But to be fair, he’s only been in industry for a couple of months, so he is probably still putting his staff into place.
The discussion on ASTM E-55 was interesting, though. I was able to fill in the missing pieces when Pat Picariello (ASTM International) outlined the mission and breadth of the ASTM organization. I knew it had been around for a while, but I didn’t realize it came about in 1898. There are currently over 12,000 standards (procedures, definitions, methods) under the ASTM umbrella, with 125 countries participating. Being a chemist, I appreciate the depth and breadth of the ASTM’s accomplishments over the years. Industries have basic compatibilities now, from angles and spacing of threads on screws to the standard manner of testing for octane ratings.
I am sure they will bring the same thoughtful and measured approach to pharmaceutical process analysis and control. In its most obvious first step, the committee is putting out a lexicon of terms. Considering that we are still not sure of what the “A” in PAT actually stands for, this is a very good start. I look forward to seeing some of the other committee reports.
The only caveat I would offer is that pharmaceuticals are different from tar paper, machine screws, potato chips, motor oil and plastic bags. There are a number of legal barriers to “industry-wide” standards being accepted. And while a majority of companies may agree on standards, there are legal precedents for standards being set by other bodies, for instance, the USP and the FDA. If “commonly agreed upon” industry standards were allowed to take precedent over law, cGMP could be ignored by consensus. While it is true that the USP and the FDA have “only one vote each” in the ASTM committees, they are both bound by the laws Congress enact and, in reality, are 800-pound gorillas in drug manufacturing.
Some pretty nice hardware was discussed, too. (That is my favorite topic.) NIR tunable laser spectrometers were discussed by Mickey B. Frish (Physical Sciences, Andover, Mass.). While the thrust of the talk was light gases (methane and carbon dioxide) and their greenhouse effects, the hardware was impressive. I can see this being applied to “off-gases” from bioreactions and drying processes in pharmaceuticals.
|Axsun Technologies' MEMS-based IntegraSpec XL spectrometer.|
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