Design and statistical analysis of method transfer studies for biotechnology products

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...