The Key Role of Analytical Methods in Technology Transfer

Assay development doesn’t end with a validated analytical method. Changes are made as a biopharmaceutical product continues through development. Often that progress includes transfer from the original laboratory to another. Whether a project is outsourced or scaled up in house, analytical methods such as bioassays must be transferred to new laboratories, with different personnel and often different equipment setups. Making sure they can repeat that validated method with equivalent results is key to both regulatory compliance and product safety and efficacy. The author of this eBook provides a stepwise strategy for doing so, from risk assessment through preparation, training, protocol preparation, and establishing criteria, to report preparation based on ALCOA+ principles. She also demonstrates how analytical method transfer plays a pivotal role in driving business growth, enabling biopharmaceutical companies to expand their production capabilities and explore new markets while ensuring consistency and reliability in product testing and quality assessment.

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