Single Use Technologies VIII
Session Descriptions
Intelligent Manufacturing Session
Session chairs: Marcus Bayer & Cameron Graham
This session will focus on the automation requirements and advancements for single use technologies that reduce manual inputs and improve product recoveries across a wide range of biopharma applications. Example topics of interest include:
- Maximizing product recovery for small volume processes through the implementation of online PAT solutions that allow monitoring of critical process parameters without product loss to sampling for off line analytics
- Implementation of online PAT for large scale processes that reduce operator intervention and allow intelligent manufacturing solutions to drive process repeatability and consistency
- Implementation of end-to-end online PAT solutions that drive communication and alignment between upstream, midstream and downstream areas of production
- Introduction of novel PAT solutions that measure additional quality attributes and process performance beyond the standard technologies that have been traditionally implemented for single use unit operations
Join us to explore how intelligent manufacturing solutions for single use technologies are driving process efficiency through the reduction of deviations resulting from manual inputs and increased recovery of your high value products.
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Ensuring Quality
Session chairs: Nicole Hunter and Ekta Mahajan
This session will provide insights into recent changes and ongoing developments in maintaining quality and regulatory compliance throughout the lifecycle of single-use technologies. We will explore topics central to their safe use including key considerations around evolving developments in materials and processes such as material integrity, extractables and leachables, and managing particulate risk. The goal is to equip attendees with foundational knowledge and practical strategies to ensure the safety and quality of biopharmaceutical products manufactured with single-use systems.
End User Journey Session
Session chairs: Chad Varner and Miriam Monge
This session seeks to capture the unfiltered, real-world experiences of end-users who have incorporated single-use technologies into their processes. We want to hear directly from you about the significant challenges you've faced and the notable victories you've achieved. Topics of interest include cost evaluations ( business case for hybrid/single-use) , implementation hurdles, validation exercises, regulatory interactions, interchangeability, scaling analysis, logistics management, enabled technologies and manufacturing strategies, optimized facility design for single-use. We welcome submissions that highlight collaborations between suppliers and end-users and encourage end-users to share their insights. By sharing these stories, you will provide critical insights that can inform and guide the next generation of advancements in single-use manufacturing.
Green Frontiers
Session chairs: Magali Barbaroux and Jon Molinari
This session will explore how single-use technologies can contribute to a more sustainable biomanufacturing industry. We will examine the environmental benefits and areas for improvement of single-use systems, especially supported by key sustainability metrics.
Speakers are invited to present on recent advancements in Single-Use Technology and how this has provided a positive impact on the Materials used, Design and Manufacturing, Transport and Logistics, Use Phase, and Post-Use Management steps. This may include novel materials and innovative packaging to more sustainable end-of-life options like recycling and bag reuse. Speakers can also discuss how Single-Use Technology has enabled a more sustainable drug manufacturing process compared to traditional Stainless-Steel technology (e.g. increased product yield, lower PMI through process intensification, etc. ). The goal is to provide a comprehensive look at how we are pushing the boundaries of what's possible for environmentally friendly manufacturing.
Call for Abstracts
Coming soon