Integrated Solutions develops and implements rapid and cost-effective biomanufacturing solutions from early phase development through scale-up to commercial manufacturing.
Our Process Development consultants will work with you from pre-clinical through phases I & II to optimize your process before design and technology choices are locked-down. We use unique modeling and multi scenario analysis tools to streamline process design and technology options, ensuring you achieve the highest productivity and lowest cost of goods.
Watch our video of a cell-based vaccine production process concept, relying completely on single-use technologies. This example shows how you can implement Flexsafe bags throughout an entire process from seed production to final filling.
As soon as Single Use technology selection has been made, our project teams will help you evaluate the extractable data package for film and components. For toxicological assessment you can then perform an extrapolation evaluation on the possible quantity of extractables in the intermediate API or drug product. We can provide full support for process risk analysis and for leachables testing. A test for leachables should be done under real contact conditions.
The Sartorius Single Use training program provides on-site, e-learning and hand-on training in our applications centers in Göttingen (Germany), New York (USA) or Shanghai (China). Our dedicated expert application specialist teams can be engaged both to support technology trials, technology training and start-up as required.