Building GMP-ready manufacturing frameworks for scalable therapies

Developers of advanced therapies must align process design, quality systems, and operational infrastructure to support scalable, GMP-compliant manufacturing. This discussion highlights approaches to building robust frameworks that enable reliable production, efficient tech transfer, and future-proofed scalability. 

Key takeaways 

• Outline key components of a GMP-ready manufacturing framework 

• Explore strategies for aligning quality systems with scalable processes 

• Discuss approaches to streamline technology transfer and process reproducibility 

• Evaluate facility design and operational practices that support growth 

• Review considerations for maintaining compliance during scale-up