Uncertainty estimates of purity measurements based on current information: toward a "live validation" of purity methods.

ABSTRACT:

Purpose

To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry.

Methods

We have conducted a comprehensive survey of purity methods, and show that all performance characteristics fall within narrow measurement ranges. This observation was used to develop a model called Uncertainty Based on Current Information (UBCI), which expresses these performance characteristics as a function of the signal and noise levels, hardware specifications, and software settings.

Results

We applied the UCBI model to assess the uncertainty of purity measurements, and compared the results to those from conventional qualification. We demonstrated that the UBCI model is

SUBMITTER: Apostol I 

PROVIDER: S-EPMC3497960 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature