Sponsored Content
- Sponsored Content
- Business
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
Already have an account?
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
You May Also Like
Sponsored Content
Jun 5 - Jun 6, 2024
Jun 5 - Jun 6, 2024
Exploit Advances in Exosomes to Improve Efficiencies in Drug Delivery: Connect with senior-level executives and scientists who will share new data and novel case studies on advancing EV products through clinical stage towards commercialization
Learn More
