Tuesday 16th September - Main Conference Day OneTuesday, 16 September 2025 - ET (Eastern Time, GMT-05:00)

Process intensification (PI) is a strategy to maximize throughput and reduce operational costs by improving the efficiency of each step in the downstream process. This session will cover the latest techniques in PI, such as multi-column chromatography, hybrid filtration systems, and integrating various purification steps. Attendees will learn how these innovations are driving faster and more cost-effective biologics manufacturing.

Round Table Session 1: Host Cell Proteins (HCPs): The Unseen Challenge

• Focus: Managing HCPs throughout the bioprocessing lifecycle.
• Key Discussion Points:
  • HCP Characterization and Detection: Advancements in analytical methods for identifying and quantifying HCPs, including challenges with low-level detection and diverse HCP populations. Discuss the use of orthogonal methods.
  • Impact of HCPs on Product Quality: Explore the mechanisms by which HCPs can affect product stability, efficacy, and immunogenicity. Focus on specific examples and case studies.
  • HCP Removal Strategies: Evaluate current HCP removal technologies (chromatography, filtration) and discuss emerging approaches (e.g., novel resins, targeted removal). Consider the challenges of removing specific "high-risk" HCPs (lipases, proteases).
  • HCP-Related Challenges in Different Product Modalities: Discuss specific HCP challenges associated with different types of biologics (e.g., antibodies, proteins, vaccines, cell therapies).
  • Setting HCP Acceptance Criteria: How do we determine appropriate levels of HCPs, and what factors influence these decisions? Discuss the role of regulatory guidance.
  • Future Directions in HCP Management: Explore innovative technologies and strategies for improved HCP control and monitoring. Discuss the role of AI/ML in predicting and managing HCP-related risks.

Round Table Session 2: Extractables and Leachables (E&L): Ensuring Patient Safety

• Focus: Understanding, controlling, and mitigating the risks associated with E&L.
• Key Discussion Points:
  • E&L Sources and Identification: Discuss common sources of E&L in bioprocessing and packaging, including materials of construction, processing equipment, and packaging components. Explore advanced analytical techniques for identifying and characterizing E&L.
  • Risk Assessment and Toxicological Evaluation: How do we assess the potential toxicity of identified E&L? Discuss the use of toxicological studies and risk-based approaches to determine acceptable levels.
  • E&L Control Strategies: Explore strategies for minimizing E&L, including material selection, process optimization, and container closure system design. Discuss the importance of supplier qualification and change control.
  • Analytical Method Development and Validation: Discuss the challenges of developing and validating robust analytical methods for E&L testing, especially for trace-level contaminants.
  • Regulatory Requirements for E&L: Review current regulatory guidelines and expectations for E&L characterization and control. Discuss differences in global regulatory requirements.
  • Emerging Trends in E&L Management: Explore new technologies and approaches for E&L analysis and control, including the use of predictive modeling and simulation.

Roundtable Session 3: Polysorbate Degradation: Protecting Product Stability

• Focus: Understanding the mechanisms of polysorbate degradation and developing strategies to mitigate it.
• Key Discussion Points:
  • Mechanisms of Polysorbate Degradation: Discuss the various pathways of polysorbate degradation, including hydrolysis, oxidation, and enzymatic degradation (with a focus on lipase contamination).
  • Factors Influencing Degradation: Explore the factors that can influence polysorbate degradation, such as pH, temperature, oxygen levels, and the presence of specific HCPs (especially lipases).
  • Analytical Methods for Monitoring Degradation: Discuss analytical techniques for detecting and quantifying polysorbate degradation products.
  • Strategies for Mitigating Degradation: Explore strategies for preventing or minimizing polysorbate degradation, including process optimization, excipient selection, and the use of inhibitors.
  • Impact of Polysorbate Degradation on Product Quality: Discuss the potential consequences of polysorbate degradation on product stability, efficacy, and safety.
  • Case Studies of Polysorbate Degradation: Share real-world examples of polysorbate degradation challenges and the solutions implemented.
  • Future Directions in Polysorbate Management: Explore new approaches for stabilizing polysorbates and preventing degradation, including the use of novel excipients and formulation strategies. Discuss the potential of more sensitive analytical methods.