Bioanalysis Zone

Design and statistical analysis of method transfer studies for biotechnology products

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Abstract

During biotechnology product development, the analytical instrumentation and methodology are often carefully selected based on the intended purpose and the scope of the analytical method. Specifically, parameters such as specificity, linearity, limit of detection (LOD) and limit of qualification (LOQ), range, accuracy and precision are evaluated [1]. After an analytical method is successfully validated and implemented, the updates of the method with the standard operating procedure will be conducted during the life-cycle of the product. The life-cycle management of analytical methods includes, but is not limited to, the following:

  • trend analyses of the method performance at regular intervals;

  • evaluation of the need to optimize the analytical method by requalification or even revalidation of all or a part of the analytical procedure due to any proposed changes (e.g., critical raw material supplier change);

  • development and validation of a new or an alternative analytical method for a new impurity;

  • transferring a validated analytical method from a sending laboratory to a testing laboratory.

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