Researchers at Codexis Laboratories in Singapore recently performed a full-factorial designed experiment with 20 runs to determine the impact of four independent variables on product selectivity during a silylation reaction. The experiment revealed that the optimal combination of factors increased the selectivity of the reaction to 97% for silylation on oxygen with less than 2% each for the undesirable alternatives. Codexis researchers adjusted the factors to increase the concentration for improved throughput, resulting in a process that delivered 95% selectivity along with an 88% yield.

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Just posted on the ICH website:

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By Mark J. Anderson, Principal, Stat-Ease, Inc.

Given the push for Quality by Design by FDA and agencies worldwide, statistical methods are becoming increasingly vital for pharmaceutical manufacturers. Design of Experiments (DOE) is a primary tool because “it provides a structured, organized method for determining the relationship between factors affecting a process and the response of that process” [1].

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By Emil W. Ciurczak, Contributing Editor

I have only given a brief description of each instrument I found interesting this year in Orlando. The two criteria I used to choose instruments for this review are: 1) is it new (within six months of Pittcon)? and 2) is it a spin on something we have, smaller and better, or completely different? The vendor could be old or new, large or small, but I only ask them to make it interesting.

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By Agnes Shanley

 At IFPAC 2012 the 26^th International Forum for Process Analysis and Control, Richard Friedman, Associate Director of FDA’s CDER’s Compliance Office’s Office of Product Quality, spoke of the need for pharma to modernize the way it controls manufacturing processes and assesses quality risks. 

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Modified-release drugs are inherently more challenging to develop and manufacture. It stands to reason that applying Quality by Design methodologies to MR products is more challenging as well—but even more important in order to understand and control their quality and efficacy.

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