Advancing Live Biotherapeutic Products: A Quality and Compliance Perspective on Development and Manufacturing

• LBPs present unique challenges for quality risk management including process control and monitoring, change management, evaluating impact of an event, and mitigating environmental risks
• Living nature of the products introduce unexpected risks to product quality, and complexity in demonstrating compliance and ensuring batch consistency
• Collaboration between Quality Assurance and Development and Manufacturing is key to identify, mitigate, and respond to these risks
• Maintaining consistent product quality and upholding quality standards

Speakers:

Kristyna Aviles

Sr Director of Quality Systems and Compliance

List Biological Laboratories Inc