Optimizing Exosome Therapeutics Manufacturing: Strategies for Scalability, Compliance & Efficiency
Time: 11:00 am
day: Pre-Conference Day
Details:
As the demand for exosome-based therapies continues to rise, i’ts crucial to address the challenges associated with scalability, compliance with GMP standards, and process efficiency. In this session, we’ll explore key strategies to overcome these hurdles and maximize the production of exosome therapeutics.
Scalability and GMP Compliance:
• Exploring methods for scaling up exosome production to meet clniical demand while maintaining GMP compliance
• Discussing the importance of integrating GMP-compliant practices into production platforms to uphold exosome purity, consistency, and functionality
• Investigating strategies for automating processes and optimizing manufacturing techniques to enhance scalability and efficiency within GMP guidelines
Batch-to-Batch Consistency:
• Address the complexities of achieving consistent quality and characteristics to maintain batch-to-batch consistency across exosome products, including managing variability in starting materials and manufacturing processes
Regulatory Understanding and Compliance:
• Examining the challenges of navigating regulatory requirements, particularly those set by the FDA, in developing and manufacturing exosome-based therapies
• Discussing effective strategies for addressing regulatory requirements throughout the manufacturing process, including collaboration with GMP firms and alignment with internal processes
