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Built to Serve Innovation: A Briefing on Commercial Readiness at Resilience
BPI Contributor
June 25, 2024
15 Min View
Date: Jun 25, 2024
Duration: 15 Min
Sponsored by Resilience
This webcast features: Duane Avant, Chief Quality Officer, Resilience & Luis Oscar García, VP and General Manager, Site Head for Alachua Site, Resilience.
While many biopharmaceutical companies are built to fulfill a need, Resilience was built to serve innovation. With a sustainable network of high-tech, end-to-end manufacturing facilities based in North America, Resilience is dedicated to providing supply chain solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale.
In this webinar, Resilience biomanufacturing leaders will introduce their commercial capabilities by showcasing existing commercial sites and sharing plans to onboard new commercial products into the network. Additionally, Resilience leaders will highlight their development and manufacturing site in Alachua, Florida and outline its path towards commercial readiness.
Key Takeaways:
Learn about commercial capabilities in the network: sites, experience, number of commercial products.
Address regulatory experience and history of regulatory audits/inspections.
Understand what commercial readiness is.
Gain insights into a general roadmap to commercial readiness, including methods for proactive compliance approach, data integrity audits, PAI readiness.
Review Alachua, FL site history (est. to present) and current capabilities.
Outline a high level roadmap to commercial readiness in ALA:
Wave 1: data integrity, cross-contamination controls, QMS procedures, aseptic process controls.
Wave 2: aseptic EM, MFG controls, batch release, new material introduction
Wave 3: material management, material segregation, training program, status label control.
Register or Login and hit Watch on Demand to view the recorded webcast now.
About the Author(s)
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Our Biopharmaceutical School is the perfect course to gain a well-rounded understanding of the Biopharmaceutical industry. Over three days, you will understand the principle steps in the biopharmaceutical lifecycle, including: raw material selection, up and downstream processes and core technology. Additionally, you will be familiarised with the latest industry trends, including Industry 4.0, and how these are likely to impact the industry’s evolution.
Through a combination of sessions led by experts from the likes of GSK and Pall Biotech, as well as group discussions with your peers, you will learn how to bring a biopharmaceutical drug to market. Each day will be chaired by a different member of the BioProcess International Academy faculty and there will also be time for networking and Q&As with the experts.
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