New Cross-Functional Perspectives Within the Agenda

Bridging Innovation Across Disciplines in Bioprocessing

As biomanufacturing advances toward Bioprocessing 4.0, the most successful organizations are those rethinking how teams collaborate, from cell line development to quality assurance. This year’s agenda at BioProcess International (BPI) West highlights cross-functional strategies that integrate engineering, process development, CMC, data science, and regulatory insight to transform how biologics are designed, scaled, produced, and delivered.

Track Breakdown: Key Focus Areas

1. Continuous Processing Integration

Associated Challenge: End-to-end continuous bioprocessing remains “rare or nonexistent” due to technical hurdles spanning multiple departments.

What You Need to Know:

• Practical knowledge of how engineering, manufacturing, and quality teams can collaborate to deploy continuous bioprocessing systems.
• Insights into how AI, PAT (process analytical technology), and real-time monitoring are being used to break the hand-offs between functions and accelerate scale-up.
• A better understanding of regulatory and operational considerations when moving from batch to continuous systems (directly linking engineering and quality).

Where Our Agenda Covers This:

• Workshop 3: “Redefining Efficiency: Intensified and Continuous Processing in Action” - exploring hybrid and fully continuous upstream/downstream platforms.
• Keynote: “Roadmap for Implementing Intensified Processing at Sanofi” - Michael Coolbaugh, Head of Advanced Manufacturing Implementation, Sanofi.

2. Cross-Team Collaboration in Cell Line Development

Associated Challenge: Cell line developers and bioprocess operators often work in isolation despite their interdependent roles.

What You Need to Know:

• Frameworks for early-stage alignment of cell line development with process engineering and manufacturing strategy.
• How AI and automation (robotics, predictive modeling) can bridge upstream and downstream silos.
• Strategies for ensuring quality and stability throughout development and production.

Where Our Agenda Covers This:

• “Integrating AI-Driven Predictive Models into Targeted Integration Workflows” - Kathryn Beal, Pfizer.
• “How Early Integration of CLD and Process Development Reduces Risk and Supports Faster, Reliable Scale-Up” - Saurabh Sen, Sanofi.
• Panel Discussion: “Ensuring Cell Line Quality and Stability from Development to Manufacturing.”
  

3. Data Management and Analysis Bottlenecks

Associated Challenge: Bioprocesses generate massive data volumes that take months to analyze across departments, limiting timely decision-making.

What You Need to Know:

• How to design data infrastructures (data lakes, digital twins) that unify R&D, manufacturing, and quality insights.
• Techniques for implementing AI/ML to transform raw data into actionable intelligence.
• Methods to dismantle departmental silos for faster, data-driven decision cycles.

Where Our Agenda Covers This:

• “Machine Learning-Enhanced Digital Twins for Quality Prediction” — Yuxiang (Henry) Zhao, BMS.
• “Building Data Lakes to Enable AI/ML Across the Bioprocess Lifecycle” — Nathan Lewis, University of Georgia.
• ''Smarter Bioprocessing: Differentiating ML and AI for Process Optimization – Industrial Use Cases and Implementation Paths” — Mark Duerkop, Novasign

4. Regulatory Compliance Across Functions

Associated Challenge: Scale-down models required for regulatory filings demand coordinated input from R&D through manufacturing.

What You Need to Know:

• Practical tools for multi-team process characterization and validation.
• How digital twins and model-informed control strategies support regulatory compliance.
• Best practices for maintaining alignment across R&D, MSAT, QA, and manufacturing.

Where Our Agenda Covers This:

• “Advanced Strategies for Process Characterisation” - workshop on CPP/CQA and risk-based modelling.
• Panel Discussion: “The Next Decade in Biomanufacturing Strategy.”
• “Scaling Genome-Edited Allogeneic CAR-T Manufacturing to Increase Access to Cell Therapies” - Justin Scoble, Caribou Biosciences.
  
  

Why It Matters

This year’s program doesn’t just showcase innovation; it redefines how innovation happens. By integrating cell line development, process analytics, and regulatory strategy through the lens of Bioprocessing 4.0, BioProcess International (BPI) West empowers attendees to build smarter, faster, and more compliant biomanufacturing pipelines.