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Abstract:
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During the biotechnology product development, the analytical instrumentation and methodology are often carefully selected based on the intended purpose and the scope of the analytical method. After an analytical method is successfully validated and implemented, the updates of the method with the associated standard operating procedure (SOP) will be conducted throughout the lifecycle of the product. Frequently, a transfer of a validated analytical method from an original laboratory (sending laboratory) to a new testing laboratory (receiving laboratory) is a common practice during the life-cycle management of analytical methods. Since the analytical method to be transferred has been already thoroughly evaluated and fully validated for its intended purpose at the sending laboratory, the main purpose of method transfer studies is usually the evaluation to determine if the two laboratories generate comparable results across the parameter ranges of interest, and to assure that the method after the transfer is still suitable for its intended use. Inconsistent advice is often seen regarding testing materials, statistical methods, and acceptance criteria in literature for the method transfe
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