By Emil Ciurczak, Contributing Editor

Sunday, January 22, 2012

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by Agnes Shanley

The GMP code requires that manufacturers run a “statistically significant” number of tests on product, and assumes that they maintain control over their processes. However, in practice, testing of batches is currently between 10-30 samples. As more drug manufacturers implement at-line, online or inline process analyzers, the number of tests run could potentially increase dramatically.

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by Agnes Shanley

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By Emil Ciurczak, Contributing Editor

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At March’s Pittcon show in Atlanta, contributing editor and analytics expert Emil Ciurczak was on a mission: find five cool, new technologies that the masses may have missed, from companies you may or may not have heard of. What follows are short clips on those techs, with explanations as to how they’ll make a difference in pharma:

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By Emil Ciurczak, Contributing Editor

IFPAC’s obligatory sunrise service, also known and the Plenary Session, began at 07:50 on Wednesday. As in years gone by, the co-chairs were from chemical and pharmaceutical pathways. Bruce Kowalski (NSF Center for Process Chemistry) gave a talk about process analysis (PA), PAT, and MVA (multivariate analysis), subjects in which he is well versed. A good speaker, he gave a pretty nice overview of PA and MVA.

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