MoBiDiK: Process Design Upstream Perfusion Clarification Chromatography Prot A Concentration Downstream Formulation UF/ DF Viral Inactivation Polishing Capto adhere/ AEX Virus Filtration disposable, modular & continuous Process Conceptual Design 2013, Thomas Daszkowski.Noscaleupduringdrugdevelopmentrequired MoBiDiKConcept.Further reduction in Manufacturing FootprintandCapex.MoBiDiK : Why Continuous Manufacturing ? 6x 20,000l bioreactors 2013, Thomas Daszkowski MoBiDiK : Fully integrated and single use Continuous Manufacturing CurrentFacilities MoBiDiKConcept NewerFacilitiesConcept Project Duration: 3 years funded by: Continuous, disposable and modular technologies to develop a functionally closed mAb process of the future 2013, Thomas Daszkowski.Partially Public Funded Project through State of NRW (Germany).Industry – Academia Consortium (9 partners).Modular, Bio production, Disposable, Konti 2013, Thomas Daszkowski.Xcellerexannouncessale of FlexFactory®Bio-productionline to R‐Pharm for newmanufacturing facility in Russia 2013, Thomas Daszkowski.MedImmune, ( Fredricksburg ), $ 600 Mill., 2011 Facility of the Year Award in the project execution category.Pfizer Biotech Campus (Grange Castle, Ireland), €1.8 billion, 6x 12,5000l bioreactors, additional €145M investment announced in Sep 2011.Bristol-Myers Squibb (Devens, MA), $750MM, 6x 20,000l bioreactors – 2011 timeframe.Status Quo: Recent Facility Announcements Need for localized, yet cost competitive production units 21.More Competition -> cost pressure on production will increase.More Potent Drugs -> reduced output per drug.Rapid Enhancements in -> allow for changes, decouple - Cell Biology (Titer) and building from equipment.Personalized Medicine -> reduced output per drug.Regional Requirements -> local instead of centralized. Trends / DriversImpact on Manufacturing.Trends / Drivers impacting Manufacturing From product and process development through the planning and construction of plants to the automation and optimization of processes. Who is Bayer Technology Services (BTS) Bayer Technology Services initiates, implements and supports technological innovations over the long term. Current and new Biotech Manufacturing concepts.Biopharmaceutical Market (Trends and Drivers).Function and Role of Bayer Technology Services.E N D - Presentation TranscriptĬontinuousBioprocessingBarcelona Spain Continuous Processing in Biotech Production: An alternative to a modern single use, batch, facility ? Thomas Daszkowski, Bayer Technology Services 21.10.
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