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This paper explores one approach for overcoming several scale-up issues with the use miniature bioreactors for process development.
By Jens-Christoph Matuszczyk, Johannes Lemke, Markus Schulze, Sabrina Janoschek, Gerben Zijlstra, and Gerhard Greller The high costs of and limits on global accessibility of biologics such as monoclonal antibodies (MAbs) are focusing the biopharmaceutical industry’s attention on strategies for rapid, economical development of such therapies. Process intensification is one approach to help shorten manufacturing timelines and reduce cost of goods (CoG) (1, 2). Today, process intensification in upstream cell culture enables biologics manufacturing in facilities with smaller footprints and lowe...
03.09.21 -- Incorporating Excipients Into QbD Studies For Drug Development -- An Introduction Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs. Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more! By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), K...