BioPharm International-06-01-2007

BioPharm International

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

June 01, 2007

Features

20

6

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..

IP Briefs: The Positive Side of Negative Disclaimers

June 01, 2007

Columns and Departments

20

6

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

Disposables: Biopharmaceutical Disposables as a Disruptive Future Technology

June 01, 2007

Features

20

6

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.

FDA Moves to Streamline GMP Inspections

June 01, 2007

Columns and Departments

20

6

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