Tuesday 16th September - Main Conference Day One - ET (Eastern Time, GMT-05:00)
- Thomas Seewoester - Vice President, Site Operations, Amgen
- Tracy Ryan - Co-Founder & Chief Communications Officer, NKore BioTherapeutics
- Sophie Ryan - Cancer Survivor & Global Advocate, NKore BioTherapeutics
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Tracy Payne - SVP Business Development, Principal Consultant Business Strategy & Operations, Windshire Group, LLC. Labshire, LLC
- Bhanu Chandra Mulukutla - Research Fellow, BioTherapeutics Pharmaceutical Sciences, Pfizer
- Mark Blenner - Associate Professor, University of Delaware
- Shruti Santhosh - Engineer II, Biogen
- Yuxin Liu - Scientist, Cell Culture Platform, Sanofi
- Marc Schrader - Senior Scientist, Abbvie
- A Representative - from, Regeneron
- Kartik Subramanian, Ph.D. - Vice President Product Development Science and Technology Biologics, AbbVie
- Yuxiang (Henry) Zhao - Senior Scientist, Bristol-Myers Squibb
- Ramani Raghavan - Managing Director, Meadowlark BioPharma
- Kartik Subramanian, Ph.D. - Vice President Product Development Science and Technology Biologics, AbbVie
- Zhengqi Zhang - Senior Scientist, Merck
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Tracy Payne - SVP Business Development, Principal Consultant Business Strategy & Operations, Windshire Group, LLC. Labshire, LLC
The CGT C-Level Forum provides a unique, powerful and valuable space for candidly sharing ideas and experiences between executives of ~20 CGT therapeutic development companies. The forum is designed to foster new ideas and create new relationships between attendees so that they can leave with tangible outcomes and that will drive their businesses and the sector forward.
An exclusive invite-only session, in a closed room setting, the forum will include 2-3 case studies discussing the right approach to engage and partner with pharma and industry. It will also include general discussion focussed on brainstorming solutions to the most pressing and current challenges of CEO/CSO/CBO/CMOs in the CGT sector.
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.
- Susan Sharfstein, PhD - Professor of Nanoscale Science and Engineering, University at Albany
- Song Zhiwei - Senior Principal Scientist, Nexa Biologics
- Lynn Mao - Senior Scientist, AstraZeneca
- Michael Butler - Principal Investigator, Cell Technology, NIBRT
- Olga Paley, Ph.D. - Director Purification Process Development, Takeda
- Christine Pham - Principal Scientist, Purification Process Development, Gilead
- Dhanuka Wasalathanthri, PhD - Associate Director, Bristol Myers Squibb
- Joanna Rucker Pezzini - President and Founder, PAK Biosolutions
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
- Kevin Zen, PhD - CMC Technical Operations, Opthea
- Lior Shaltiel - CEO, NurExone Biologic
- Renée Hart - President & Chief Business Officer, LumaCyte
- Wolfram Carius, PhD - Executive Vice President, Pharmaceuticals, Cell and Gene Therapy, Bayer Pharmaceuticals
- Erin Kimbrel - Head of Cell & Gene Therapy Research, Astellas Institute for Regenerative Medicine
- Stephen Kennedy - Head of Technical Operations, CRISPR Therapeutics
- Ruth Salmon - VP, BMS Cell Therapy Research, Bristol Myers Squibb
- Bryan Poltilove - Strategic Advisor and Independent Board Director, Independent
- Daniel Friedman - Principal, BroadOak Capital
- Aaron Fisher - Director, Life Sciences Investments, ARCHIMED
- Fiona Miller - Managing Partner, quadraScope Ventures
- William Whitford - Founder, Oamaru BioSystems
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.
- Alexander Fuchs - Head of Product Line Management & Product Innovation, Single Use Support
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.
- Eric Bowen - Director of Product Management, Novilytic
- Steffen Goletz, PhD - Full Professor, Head of Biotherapeutic Glycoengineering and Immunology - Institute for Biotechnology & Biomedicine, Danish Technical University
- Ana Di Lillo - Scientist, AstraZeneca
- Emily Rittershaus - Principal Scientist, Process Development Upstream Biologics Development, Bristol Myers Squibb
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.
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University
- Derek Hubley - Director, Lonza
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
- Victoria Kennedy - Senior Scientist, Sanofi
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.
- Linda Yi - Director, Analytical Development, Biogen
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.
- Katelyn Pritchard - Viral Clearance Study Director, Texcell – North America, Inc.
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
- Joe Vogel - Vice President, OUTbio
- Debra Fowler - Executive Director and Co-founder, History UnErased