Adaptation of the analytical control strategy of a commercial vaccine... - ERP Spain.com - España y América Latina

Full Title: Adaptation of the analytical control strategy of a commercial vaccine using the principles of QbD. Challenges, lessons learned and improvement perspectives. The principles of Analytical Quality by Design (AQbD) were applied in the context of revisiting the control strategy applied to a recombinant protein antigen used in a commercial vaccines. Tools and approaches that were initially designed for applying AQbD on the development of analytical methods for new products were used. The objective of this presentation is first to advocate that QbD and AQbD principles can be advantageously applied to the lifecycle of commercial products and corresponding analytical methods. Second, to share the specific difficulties encountered on some items; but also, sometimes the surprising easiness on other items; and this precisely because we were working on a commercial product. Finally, we want to discuss the pro’s and con’s of applying (A)QbD principles, approaches and tools on commercial products and what would be the best route(s) between a systematic & dogmatic application of these principles and a conservative omission.