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

• Strategies to maintain minimum pressure to prevent viral particle penetration

• Practical considerations for implementing viral filtration in continuous processing

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.

This session will take a grounded approach to the application of AI in biomanufacturing, exploring practical use cases, addressing common misconceptions, and discussing the limitations of current AI technologies.

As gene therapy evolves beyond AAV-based delivery systems, new analytical challenges arise in ensuring genome integrity, optimizing therapeutic dosing, and mitigating immunogenicity risks. The industry is shifting toward alternative delivery methods such as CRISPR-based therapies, lipid nanoparticles (LNPs), plasmids, and synthetic vectors, requiring advanced analytical approaches to maintain product quality, efficacy, and regulatory compliance. This session will explore: Genome integrity analysis beyond traditional capsid characterization, leveraging long-read sequencing and multiplex digital PCR to assess payload stability and completeness, optimizing viral vectors for complete genomes, reducing dosing requirements, improving patient outcomes, and lowering production costs, second-dose strategies for non-AAV gene therapies, addressing durability, re-dosing challenges, and immunogenicity considerations, emerging analytical approaches for non-AAV delivery systems, including mRNA-based CRISPR therapies, LNP formulations, and synthetic gene vectors, key regulatory considerations for characterizing non-viral gene therapy platforms, ensuring alignment with evolving global standards.

Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.

This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.

Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event at BioProcess International.

Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.

This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.

Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event at BioProcess International.

Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.

This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.

Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event at BioProcess International.

Join us for an engaging Lunch & Learn session where leading technology, product, and service providers showcase the latest advancements in bioprocessing. Enjoy your meal while exploring cutting-edge solutions designed to enhance efficiency, scalability, and innovation in biomanufacturing.

This interactive session offers a unique opportunity to gain insights into breakthrough technologies, ask questions directly to industry experts, and network with peers—all in a relaxed, informal setting.

Whether you're looking to optimize your processes, explore new tools, or simply stay ahead of industry trends, this is a must-attend event at BioProcess International.

Examples of working with biopharma customers to optimize raw material formulations for specific applications.

This talk will focus on specific strategies for removing high-risk HCPs, such as lipases, chromatin, and other species that bind to proteins or cause other processing issues. It will discuss the use of functionalized resins and membranes.

The biopharmaceutical industry is moving towards greater flexibility and efficiency in manufacturing. This session will explore the concept of integrated, product-agnostic biomanufacturing facilities – those designed to produce a range of biologics using common equipment and platforms. Attendees will learn how this approach can reduce capital costs, accelerate development timelines, and improve responsiveness to market demands.

Regulatory expectations for potency and release testing are evolving, particularly with the rise of advanced biologics such as CGTs, ADCs, and bispecific antibodies. Companies must navigate challenges in assay standardization, surrogate potency methods, and comparability assessments while ensuring compliance with global regulatory frameworks. This session, led by industry experts and regulatory specialists, will provide practical insights into meeting the latest standards, including ICH Q6B (Specifications for Biotechnological/Biological Products), USP General Chapter <1032> (Design and Development of Biological Assays), and FDA guidance on potency testing for gene therapy products. Attendees will gain actionable strategies for improving assay validation, reducing variability, and streamlining regulatory approval pathways.

• Addressing supply chain disruptions: strategies for procurement, digitalization, and raw material management

• Sustainability challenges and cost-saving innovations for large-scale media production

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.

Round Table Session 1: Tackling Variability in Cell-Based Bioassays: Strategies for Achieving Consistent and Reliable Results

Cell-based bioassays are crucial for potency testing, yet their inherent variability can lead to batch failures and regulatory delays. This roundtable explores best practices and innovative strategies for achieving consistent and reliable results. Standardization efforts are critical for improving accuracy and global harmonization of potency testing.

Key discussion points:

Optimizing assay conditions to enhance batch-to-batch reproducibility.-

• Data-driven approaches, utilizing statistical modelling and real-time monitoring, to minimize variability.
• Leveraging AI tools for unbiased cell analysis, automated gating in flow cytometry, and improved data insights
• Understanding and meeting regulatory expectations to ensure compliance and reduce rework.
• The impact of AI-driven automation for increasing throughput while maintaining assay integrity
• Case studies showcasing successful strategies for minimizing variability and improving assay performance.

Round Table Session 2: Accelerating Product Release – Overcoming Challenges in Real-Time Release Testing (RTRT)

Real-Time Release Testing (RTRT) is a transformative approach to batch release, offering faster turnaround times, cost reduction, and improved process control. However, many companies struggle with RTRT implementation, regulatory acceptance, and aligning process analytical technology (PAT) with manufacturing workflows Participants will gain practical insights into integrating RTRT into their workflows, helping to accelerate product release and enhance overall biomanufacturing efficiency.

Key Discussion Points:

• Leveraging PAT and advanced data analytics to enable RTRT in GMP environments
• Overcoming regulatory and technical barriers to RTRT adoption
• Case studies on successful RTRT implementation, demonstrating how companies have improved efficiency and compliance.