The use of multivariate models in a regulated environment within continuous manufacturing for pharmaceutical products

Monday, September 16, 2019

Time: 15.00-16.00 (CEST)

Sartorius Stedim Data Analytics (SSDA) invites to a webinar on the use of Umetrics® Suite in continuous manufacturing.

Continuous manufacturing is one of the key trends within the pharmaceutical industry, both for the production of ‘classical’ drugs as well as large molecules. Companies are looking for ways to shift from traditional start-stop processing to a continuous way of operation. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, but also more consistent quality of the drug product. The regulatory bodies such as the FDA see the promise of these processes and actively promote companies to implement this manufacturing strategy. This is illustrated by the recently published draft guidelines from the FDA for the production of small molecule drugs using continuous processes and the active discussion with the (bio)pharmaceutical industry through their Emerging Technology Program.

The amount of data and information generated in continuous processing creates new opportunities to expand the use of multivariate process modelling. This webinar will go into the role of multivariate models to be used for active process control and ‘Real Time Release Testing’ as part of the overall control strategy for continuous processes under the newly published draft guidelines. It will further discuss the use of these models within a regulated environment, where it’s key to understand the advantages and risks to build a model validation strategy.

This webinar is presented by Kai Touw, who works as Biopharma Market Manager at Sartorius Stedim Data Analytics. Within this function he works on the application of advanced data analytics in the biomanufacturing industry and how process data can be used for simulation and statistical modelling for process design and control. Before taking up this role Kai has been working on process intensification and next generation facility concepts as a Process Development Consultant at Sartorius Stedim Biotech. Furthermore, he has several years of PD experience, working at Janssen Vaccines & Prevention (former Crucell) in Leiden (NL) on the development and scale-up of an intensified production platform for viral vectors. Kai holds an engineering degree from the technical university of Delft (NL).

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