Day Two

• Integrating PAT data with AI and digital twins and harmonizing and contextualizing analytics to enable actionable insights and faster, better informed manufacturing decisions with less reliance on offline testing
• Developing and validating digital twins using FDA funded programs and regulator endorsed methodologies to gain regulatory confidence in advanced models, reduce risk and accelerate adoption in GMP manufacturing
• Replacing traditional analytical benchmarks with PAT and model-based approaches developed in collaboration with regulators to establish modern acceptance criteria that support successful filings while future proofing process control strategies

• Establishing a continuum from R&D through MSAT to commercial manufacturing, integrating PAT, digital twins, and automated processes to support real‑time decision‑making and continuous manufacturing across modalities
• Addressing key implementation challenges including demonstrating business value, managing evolving AI/ML capabilities, and ensuring systems are sufficiently mature for GMP deployment
• Exploring pathways to replace traditional QC release testing with real‑time monitoring, while driving regulatory acceptance, ensuring compliance, and upskilling cross‑functional teams

Not every challenge in process monitoring warrants a long deep dive. This quick‑fire solutions session is designed to surface common adoption and implementation barriers – and address them head‑on with practical, experience‑led insights from across the room.

Through a series of focused prompts and rapid audience discussion, participants will share what has worked, what hasn’t, and where small changes have delivered disproportionate impact. The goal is to help teams move past minor but persistent obstacles that slow adoption, drain resources, and delay ROI.

Topics to be covered include:

• Does lean chemometrics have a place in PAT?
• Advancing Process Monitoring & Control Strategies in Gene Therapy Manufacturing
• When to take the right sample at the right time?
• Low‑cost wins that improved monitoring adoption fastest
• Getting CMOs on board without changing validated systems

• Which process monitoring technologies will actually deliver measurable ROI in the next 3–5 years, and how do you prioritise investment to avoid over‑promising and under‑delivering?
• How can organizations confidently balance innovation with GMP risk, product sensitivity, cost, and operational complexity to ensure new technologies enable rather than disrupt manufacturing performance?
• In what ways can evolving regulatory guidance be leveraged to accelerate adoption and strengthen control strategies, rather than acting as a barrier?
• What approaches actually work when retrofitting new monitoring tools into legacy systems, and when does it make more sense to invest in greenfield solutions?

• Defining the right data, architecture, and monitoring strategies to support continued process verification in highly variable, patient specific production environments
• Sharing lessons learned from developing and implementing a new process monitoring solution while maintaining existing filings and enabling seamless CPV execution
• Exploring how to layer data architectures and leverage available resources to streamline day to day monitoring while future proofing for more advanced, connected technologies