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San Kiang, director for process R&D at Bristol-Myers Squibb's Pharmaceutical Research Institute, New Brunswick, N.J., tells about a similar outcome for a compound that had been in development for 10 years. "The sky dropped one day--a new polymorph was discovered in the pilot plant," he says. In this case, putting the pilot plant under quarantine and imposing manufacturing protocols like those for operating under sterile conditions allowed production of the old form to continue, he says. The drug product now in the market contains the original polymorph, he adds. Kiang recalls a recent incident in the manufacture of an intermediate. "One of the impurities had always been an oil," he explains. "It never crystallized, so it was easily eliminated during processing. But one day, it crystallized and became an impurity in the product. It took a lot of process redesigning to eliminate this new crystal, which had never formed before."
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