BioPharm International-06-01-2007

One goal of process characterization is establishing representative performance parameter ranges that can be used to set validation acceptance criteria (VAC). Characterization studies yield varying numbers of data points from multiple experiments, and may also include data generated at different scales (e.g., bench, pilot, and commercial), which add complexity to the analysis. Many statistical approaches can be used to set ranges from large data sets. As an example, we present the statistical considerations and techniques for setting validation acceptance ranges for a chromatography step used in purifying a recombinant protein. Performance parameter data from a combined data set consisting of 67 bench, six pilot, and three full-scale runs were analyzed using the statistical analysis software JMP (SAS Institute). The combined data set was used to compute tolerance intervals, so that sources such as scale and column feed material could be properly modeled. The resulting ranges were used to establish..

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June 01, 2007

Without charges for some large merger deals, the publicly traded US biopharmaceutical industry would have been profitable in 2006-for the first time.

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June 01, 2007

Addition of a disclaimer to a claim, based on words not present in the application as filed, is referred to as an undisclosed disclaimer.

Outsourcing has been a cornerstone of our industry for decades.

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June 01, 2007

In China, the presence of a substantial biogenerics industry reflects a growing need to provide healthcare to domestic populations, at a reasonable cost.

Today, most disposables are used for process development and clinical-scale manufacturing. Substantial growth in disposables usage may not occur until disposables are incorporated into the production of licensed products at commercial scale.

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June 01, 2007

FDA's approach involves adopting efficient strategies for targeting inspections to more high-risk operations likely to have the greatest impact on public health.

Discrete simulation allows the design teams to see every meaningful detail about equipment and materials flowing through the process.