This all-day event, featuring panel discussions and presentations by members of the academic and biomanufacturing communities as well as regulators and government representatives will examine the vision, strategy and process to implement real time release to facilitate biopharmaceutical manufacturing.
Real Time Release in Biomanufacturing:
Is this the path to efficient
production of high quality biopharmaceuticals?
The biomanufacturing industry has developed and implemented useful technologies and sophisticated quality management systems to ensure the high quality of products released from production processes. Systems and technologies that could also enhance the production efficiency and reduce the cost of goods are desirable. Real Time Release (RTR) methods have been practiced in many sectors of the biomedical industry, including in the manufacture of small molecule pharmaceuticals. In biomanufacturing, their implementation is evolving and far from maturity. In this meeting, we will explore the potential role of real time release in biomanufacturing toward establishing a framework for implementation to maximize its benefit to biomanufacturing stakeholders.
Some key questions that this Summit will address include:
- What is the potential benefit of RTR from the industry perspective?
- What is the view of regulators on the impact of RTR on product quality, and what is the road map for successful implementation?
- What are the success factors or obstacles manufacturers need to consider and manage to incorporate and implement RTR to their process?
The overall goal of the meeting is to review the status of RTR from multiple perspectives of stakeholder and highlight important issues impacting innovation. These could include a technology gap, cultural inertia, or communication between key partners. The compilation of these issues will form the starting point for a panel discussion among experts and the attendees.