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

Single-use bottles continue to play a significant role in biomanufacturing, yet they often fall short in supporting closed, aseptic, and scalable fluid management. This presentation explores how automated single-use bottle filling bridges that gap. By combining process flexibility with cGMP compliance, automated systems are helping manufacturers streamline drug substance handling while staying adaptable to different bioprocessing needs. Automation is not just a technical upgrade, but a strategic enabler for modern bioprocessing.

Sample preparation bottlenecks pharmaceutical research because every touchpoint introduces potential for manual error. Explore the patented Proteometer technology that Novilytic is utilizing to eliminate this step, helping pharmaceutical companies bring medicines to market faster and more cost-effectively by optimizing upstream workflows when evaluating proteins with an FC region.

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: Approach to complying with the latest FDA guidelines on Ethylene Glycol (EG) and Diethylene Glycol (DEG)

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.

Since 2017, Texcell has supported clients with AAV viral clearance studies using novel approaches to identify what works best for their processes. By sharing key insights, addressing unique AAV challenges, and offering proven strategies, we help partners meet regulatory expectations and ensure safe, efficient development of gene therapy products.

Join us for an engaging fireside chat exploring the mission and impact of History UnErased, an organization dedicated to integrating LGBTQ-inclusive history into mainstream K-12 education.

• The importance of accurate and inclusive US history and civics education
• History UnErased's mission and educational approach
• Current challenges in LGBTQ+ representation in K-12 curricula
• Success stories and impact on students and educators
• Upcoming collaborative initiatives between OUTbio and History UnErased
• How industry professionals can support inclusive education efforts
• Preview of the upcoming joint fundraiser