BioPharm International, June 2007 - BioPharm International

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BioPharm International, June 2007
Features
Process Validation: Using Tolerance Intervals for Setting Process Validation Acceptance Criteria
By Rick Burdick , Tom Gleason , Steve Rausch , Jim Seely
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..
Facility Design: Simulation Methodology for Facility Design
By Jim Curry
Discrete simulation allows the design teams to see every meaningful detail about equipment and materials flowing through the process.
Disposables: Biopharmaceutical Disposables as a Disruptive Future Technology
By Eric S. Langer , Brandon J. Price
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.
Columns and Departments
From the Editor: On the Cusp of Profitability
By Laura Bush
Without charges for some large merger deals, the publicly traded US biopharmaceutical industry would have been profitable in 2006—for the first time.
China Today: Biogenerics in China: An Evolving Industry
By Eric S. Langer
In China, the presence of a substantial biogenerics industry reflects a growing need to provide healthcare to domestic populations, at a reasonable cost.
IP Briefs: The Positive Side of Negative Disclaimers
By Judy M. Mohr , Gina Freschi
Addition of a disclaimer to a claim, based on words not present in the application as filed, is referred to as an undisclosed disclaimer.
FDA Moves to Streamline GMP Inspections
By Jill Wechsler
FDA's approach involves adopting efficient strategies for targeting inspections to more high-risk operations likely to have the greatest impact on public health.
Final Word: Outsourcing in Today's Risk-Based Environment
By Bikash Chatterjee
Outsourcing has been a cornerstone of our industry for decades.

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