BEGIN:VCALENDAR VERSION:2.0 PRODID:-//Eventin//Event Calendar//EN CALSCALE:GREGORIAN METHOD:PUBLISH BEGIN:VEVENT UID:e48411cfb222b89c2af83b0ff0297b2d@mivado.com SUMMARY:Continuous Manufacturing Processes for Biopharmaceutical Products DESCRIPTION:Continuous Manufacturing Processes for Biopharmaceutical Produc ts\nDescription\nThe biopharmaceutical industry is driven by the need to in crease production and reduce costs while maintaining product quality and ha s increasingly focused on intensification of processes to accomplish this g oal.  The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities\, the bioind ustry should further improve speed to clinic\, gain in manufacturing flexib ility while reducing costs of goods sold. Whereas continuous manufacturing is now well considered for small molecules\, it is not yet the case for bio logics. Despite some challenges that still exist in applying continuous man ufacturing processing for biologics\, this approach could address some of t he current limitations of large-scale fed-batch processes.\nWhy should you attend?\n\nUnderstand how continuous manufacturing aligns with data integri ty and digital transformation to increase manufacturing and operational pro ductivity\, excellence\, and product quality\nLearn how to navigate and ove rcome key process challenges for the successful implementation of continuou s manufacturing:\n\n\n\n\n\n\n\n\n- Develop control algorithms\n- Implement PAT technology\n- Design continuous equipment for all unit operations\n- D evelop a strategy for bioburden control\n- Overcome a lack of operational e xperience\n\n\n\n\n\n\n\n\n\nObjectives\n\nSetting up the context of the bi oindustry\, leading to the development and implementation of new manufactur ing technologies for recombinant proteins\nUnderstand the upstream and down stream manufacturing technologies\, past\, present\, and future\, their res pective benefits and drawbacks\nPropose methods to build a continuous proce ss\nLearn how to implement process analytical technologies (PAT) to provide operators with greater control of the cellular environment and metabolism\ nUnderstand the benefits of applying continuous manufacturing (regulatory f lexibility\, manufacturing flexibility\, productivity\, and economics)\nUnd erstand the regulatory expectations on continuous manufacturing (ICH Q13)\n What are the challenges?\nLearn the specificities of continuous manufacturi ng when considering its validation\nUnderstand how to set up a control stra tegy for continuous processes\n\nWho should attend\n\nBig\, medium\, and sm all-sized pharma companies\, medical device companies\, biopharma companies \nProcess development\nCMC development program\nManufacturing Science and T echnology\nManufacturing and Operation\nQC and stability control\nQuality A ssurance & Validation\nDrug Regulatory Affairs\n\nEducation approach\n\n\nL ecture sessions are illustrated with practical questions and examples\n\nPr actical exercises include examples and discussions\n\n\nSpeaker\n\nKossi Mo lley\, Chemist\; LSSBB\; PMP LOCATION:Online DTSTAMP:20260919T103445Z DTSTART:20261007T130000Z DTEND:20261007T200000Z END:VEVENT END:VCALENDAR