Product Lifecycle, Lifecycle Maturity Model and Real Time Release Testing for BioTech Products

The importance of the Product Lifecycle is increasing important in an industry that requires faster time to market, reduced costs and improved scalability. This session will provide an overview from Line Lundsberg-Nielsen on the Product Lifecycle Strategy Maturity Model as developed by the PAT-LCS Community of Practice, and its status in defining and harmonizing key capabilities in order to achieve advanced manufacturing control strategies. Christoph Herwig will also explore the role of the Digital Twin in the product lifecycle, increasing process robustness and productivity and how it will be an essential component in the digital transformation of the biopharmaceutical industry. 

One of the major outcomes for the introduction of new techniques and technologies is the opportunity to develop Real Time Release Testing for biotech products. The presentation by Lorenz Liesum will include discussion of new analytical technologies, multivariate analysis with the goal of simplifying and reducing the overall release lead time.