Articles by Rick Burdick - BioPharm International



Articles by Rick Burdick

Rick Burdick

Considerations in Identification and Qualification of Spectrophotometer Equipment for Microbial Fermentations
May 1, 2011

The authors outline qualification procedures for a process-critical piece of equipment.

Demonstrating Comparability of Stability Profiles Using Statistical Equivalence Testing
March 1, 2011

The authors present an approach for testing statistical equivalence of two stability profiles.

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..



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