Pharma and FDA have been cutting back on staffing and employee training to save short-term costs, in a move that will cost them dearly in the long term. The results have already been seen at FDA, whose leaders plan to reverse this trend.
We surveyed our readers last year to learn what they were doing in process control. We included a question on "open control" only to learn that most readers had not even heard of S-88 and S-95, key elements in more progressive automation platforms at companies that include Novartis, Genentech and Pfizer.
Last month's contaminated pet food story has been followed by news of contaminated feed reaching pigs and chickens. Theories are still being explored. Melamine has been identified as the key culprit, but API manufacturing expert Girish Malhotra, who doesn't buy the "contaminated process water" theory, asks "did we miss other...
Right now, utilizing Process Analytical Technologies (PAT) is anything but "plug and play." Two years ago we first heard about C-PAT, spearheaded by Pfizer, which aimed to develop a standard interface for process analytical technologies (PAT). Haven't heard much about that effort lately.
We recently interviewed Tunnell Consulting expert, Phillipe Cini, for his perspectives on Quality by Design, Lean Manufacturing, and Process Analytical Technologies. Cini, in a previous life at BMS, had overseen the $7.8-billion acquisition and integration of DuPont Pharmaceuticals.
Last week, an expert had suggested that the wheat used in the contaminated pet food might have been intentionally adulterated, and melamine added to improve the protein levels recorded by NIR, thus ensuring a higher price. Melamine polymer isn't toxic but monomer is.
For the hard-core analytical geek, we've received a call for papers to the 2008 Winter Plasma Spectrochemistry conference in Temecula, California, from January 6-12. Topics include: elemental speciation, laser asisted spectroscopy, new plasma insrumentation, micronebulizers and plasmas and stable isotope analyzers.
One problem with process analytical technologies' (PAT) acceptance in pharma is the fact that companies are unwilling to invest in PAT until they know that it will work for them. And knowing it will work generally requires investing in technologies and hiring consultants to help with methodologies, and trying PAT out.