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Facility Design: Simulation Methodology for Facility Design

June 1, 2007

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

IP Briefs: The Positive Side of Negative Disclaimers

June 1, 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.

Final Word: Outsourcing in Today's Risk-Based Environment

June 1, 2007

Outsourcing has been a cornerstone of our industry for decades.

FDA Moves to Streamline GMP Inspections

June 1, 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.

Process Validation: Using Tolerance Intervals for Setting Process Validation Acceptance Criteria

June 1, 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..

China Today: Biogenerics in China: An Evolving Industry

June 1, 2007

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

From the Editor: On the Cusp of Profitability

June 1, 2007

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

Rapid High-Throughput Feed Optimization

May 2, 2007

Growth of CHO cell cultures in a shaker plate model system was demonstrated to be comparable to growth in shake flasks.

Applying Fusion Protein Technology to E. coli

May 2, 2007

Protein expression remains an arduous task that involves a complex decision tree. Establishing tools and optimal conditions for each protein remains an empirical exercise.

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