Opening Plenary: A New Decade for Continuous Manufacturing
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Continuous manufacturing for pharmaceutical and biopharmaceutical manufacturing is still in its infancy with only a limited number of products approved within the past 5 years. As we begin the third decade of the third millennium, we anticipate that bio/pharmaceutical manufacturing will continue to get smaller, faster, and smarter. In this opening conference session, a broad array of speakers from industry, academia, and regulatory agencies will provide their views on the state of continuous bio/pharmaceutical manufacturing today and predictions for its future.
Current Status on CM for Biologics: Development to Clinical
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Speakers will provide insights on the current stage of deployment of CM for biological molecule clinical manufacturing from the point of view of process technologies, facility assets, and manufacturing operations. Examples of successes as well as challenges encountered will be shared.
Success Stories from Small Molecule Drug Product
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Significant progress in CM implementation has been made over the last ten years. From fundamental studies within academia to global drug product CM approvals, CM represents a paradigm shift within the industry that will continue to grow with time. In this session, success stories from some of the early adopters and implementers will be shared which include regulatory, technical, and business-related achievements in the hope that it will encourage others to join the CM movement!
Emerging Technologies
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The session brings together industrial case studies from practitioners who have delivered innovative solutions to enable the adoption of continuous processing within their companies.
Analytics Considerations for Continuous Manufacturing
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This session will be a series of presentations related to analytics and release assays critical to successful implementation of CM. The session will include perspectives on emerging approaches for assessment of quality attributes, on release testing, and on the importance of process control and PAT.
Implementation Approaches for Large Molecule Continuous Manufacturing
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This session will focus on the integrated and continuous biomanufacturing process applied in the production of large molecules with experience shared by Sanofi, Pfizer and BI. Several areas will be discussed including leveraging the at-scale data to support comparability studies, as well as prePPQ campaigns, and lifecycle process validation considerations.
Moderator(s):
Advances in Continuous Manufacturing for Small Molecule
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While continuous processes started with a few continuous steps, the maximal value of continuous manufacturing will be gained from increased integration. Several recent processes demonstrate this value. This session will focus on actual industrial processes, emphasizing the technical and business advantages of integration. Advances in the integration of unit operations, independently for API and drug product as well as the end-to-end integration of the two will be discussed over the course of the session.
This session will include 3 highly regarded experts in the CM for biological molecules. These experts will share perspectives and experiences on the development and potential adoption of CM for large molecules.
Expert Roundtable: How Do We Realize the Full Potential for Small Molecule in the New Decade?
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Panel discussion with experts in the area of small molecule continuous manufacturing will discuss the technical, regulatory, and business hurdles for continuous manufacturing. This session will highlight CM as a continuum from E2E to hybrid approaches, including the need for "batch steps" for some products, requirement differences which can be a hindrance to global implementation of advanced technologies enabled by CM such as PAT, RTRT, and modeling; and why E2E CM may or may not be the optimal solution.
Moderator/Speaker(s):
Continuous Manufacturing for Emergency Preparedness and Rapid Response: Accelerating Widespread Adoption
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The onset of the COVID 19 pandemic has illustrated the importance of the FDA's desired state of a "maximally efficient, agile, flexible pharmaceutical manufacturing sector". Continuous manufacturing has the potential to rapidly respond to changes in demand due to local or global changes. Speakers in this session will discuss how government agencies, pharmacopeial organizations, and industry are working to advance continuous manufacturing and the potential of this technology to respond to the current situation and future challenges.
