Built to Serve Innovation: A Briefing on Commercial Readiness at Resilience

BPI Contributor

June 25, 2024

15 Min View
Resilience logo

Date: Jun 25, 2024

Duration: 15 Min

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.

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