Universal Qualification of Analytical Procedures for Characterization and Control of Biologics.

Abstract A diverse set of analytical tools is required to characterize the complex structural properties of biopharmaceutical products and to ensure their quality, stability, safety, and efficacy. It is generally necessary to demonstrate that such tools are capable of measuring one or more intended attribute(s) of the product with a desired degree of precision, accuracy, linearity, specificity and sensitivity. Here we present a general framework upon which experiments may be designed to establish analytical procedure performance, predicated on the hypothesis that many analytical procedures have universal performance characteristics – that is, the validity of the measured result is a function of the measurement system and data characteristics and is not a function of the specific analyte being measured. Using simulated data, we demonstrate that the generalized approach improves the scientific validity of resulting descriptions of procedure performance by reducing the incidence of false failures and missed faults during future use of the procedure. Broad adoption of these principles will facilitate an improved understanding of procedure performance characteristics while requiring fewer human resources for procedure qualification studies.