2024 In-Person Breakout Discussions

Engage in in-depth discussions with industry experts and your peers about the progress, trends and challenges you face in your research! Interactive discussion groups play an integral role in networking with potential collaborators, provide an opportunity to share examples from your work, and be part of a group problem-solving endeavor.

These will take place IN-PERSON ONLY. Please check back for more!

CHECK BACK FOR THE 2025 LIST

TUESDAY AUGUST 20: 10:45 – 11:30 AM

CELL LINE ENGINEERING & CELL CULTURE OPTIMIZATION

TABLE 1:  Advances in Cell Line Engineering

Moderator: Susan Sharfstein, PhD, Professor, Nanobioscience, Nanoscale Science and Engineering, University of Albany

  • Multi-omics approach
  • Precision gene editing with CRISPR
  • Targeted integration and NGS
  • Cell-free systems for production
  • AIML in cell line engineering

TABLE 2:  Cell Culture Processes: Better Through AI Technology?

Moderator: Angela Botros, Process Modelling Scientist and Machine Learning Expert, DataHow

  • ​Is there a potential for Upstream cell culture development to advance on the statistical methods and find new solutions?
  • Status Quo in Cell Culture
  • From CQAs to Process Dynamics
  • Mechanistic Modelling vs Data-driven (Machine Learning) Modelling
  • Potential of AI-driven Technology for Cell Culture Development
  • Accelerating Insights by Simplifying Tasks

INTENSIFIED & CONTINUOUS PROCESSING

TABLE 3: What Are the Remaining Technical Barriers Limiting the Widespread Adoption of More Sustainable Manufacturing?
Moderator: Philip Probert, PhD, Technology Lead, CPI, United Kingdom

  • Despite interest and demonstration of intensified and continuous platforms for biologics manufacturing, uptake remains low. 
  • What are the perceived risks in moving away from conventional batch-based processing for new products?
  • Will there ever be a sufficiently strong driver for moving approved drugs to more sustainable manufacturing approaches?
  • What further advice could regulators give to guide process developers and manufacturers to de-risk more complex production approaches?
  • Are we confident that product quality is sufficiently maintained in more complex production processes, and do we have right methods to show this?

TABLE 4: Process Intensification Strategies: What To Do When and Where in Your Product Lifecycle
Moderator: Stefan R. Schmidt, PhD, MBA, CEO, evitria AG

  • Early development: Increase speed and reduce material consumption
  • Late stage development: Maximize robustness
  • Commercial: Adapt to facility and reduce COGS

GENE THERAPY CMC AND ANALYTICS

TABLE 5: Formulation Strategies for Gene Therapies
Moderator: Kruti Soni, PhD, Scientist, Technical Development, Biogen

  • Formulation
  • Stability for Gene Therapies
  • Forced Degradation
  • Device Selection​

TABLE 13: Gene Therapy Analytics
Moderator: Aishwarya Bapat, PhD, Scientist, Process Development, Moderna

  • New modalities and latest technologies 
  • Utilizing HTP analytics 
  • Advances in process analytics 
  • Multi-attribute methods

CELL THERAPY CMC AND ANALYTICS

TABLE 6: Potency Assays for Cell and Gene Therapies
Moderator: Diana Colleluori, PhD, MBA, Senior CMC Consultant, CMC Analytical, Biologics Consulting Group

  • ​Regulatory Expectations and Updates
  • Assay Development Across Product Lifecycle  
  • Standardization and Validation
  • Common Challenges

TABLE 7: Developing Successful Cell Therapies
Moderator: Scott R. Burger, Principal, Advanced Cell & Gene Therapy LLC

  • ​Latest FDA Guidance
  • Translating Science into Products
  • Target Product Profiles
  • Maintaining Quality Across Lifecycle

mRNA Development, Analytics and Manufacturing

TABLE 8: mRNA Production Platform: Global Engineering Challenges and Opportunities
Moderator: Amit Kumar, PhD, Global Engineering- Site Lead Biomanufacturing Facility Design and Capital Project, Moderna

  • Facility Design Essentials: Key considerations for designing flexible, modular facilities.   
  • Global Process Standardization: Strategies for maintaining consistency and quality across multiple sites.
  • Automation and Digitalization: Implementing Industry 4.0 solutions for streamlined production.
  • Regulatory Compliance: Navigating global regulatory landscapes and ensuring GMP compliance.
  • Technology Transfer: Best practices for seamless scale-up and technology transfer.

    Accelerating Analytical Development

    TABLE 10: Digitizing Historical Bioprocess Data: Challenges and Solutions
    Moderator: Christina Vessely, PhD, Senior Consultant, CMC Analytics & Formulation Development, Biologics Consulting Group, Inc.

    • What methods are people using to convert written/non-electronic historical data into electronic data or formats that can be easily searched via electronic means?
    • What controls are in place to assure data integrity in the conversion of historical data to electronic formats
    • What is the scope of data transformation? Early development through commercial, or just PPQ and beyond, or??? Release and stability data only or in-process data?
    • Are you handling non-GMP data that is reported in filings in the same manner that you are handling GMP release/stability data?
    • What is the biggest hurdle to assimilating historical data?

    TABLE 11: Turn Workflow Challenges into Data Science Projects
    Moderator: Varsha Daswani, PhD, PMP, Senior Director, Data Strategy, Lumilytics

    • How would you summarize your workflow?
    • What are the major bottlenecks?
    • How could automation, data science, or AI eliminate these bottlenecks?
    • How to turn these ideas into a data science project

    RAPID METHODS TO ASSESS STABILITIES AND IMPURITIES IN BIOLOGICS

    TABLE 12: Can We Use a Mass Spec-Only Strategy for HCP Characterization?
    Thomas Kofoed, PhD, Co-Founder & CEO, Alphalyse, Denmark

    • In which situations will it be relevant to use an MS-only strategy?
    • What will it require to use an MS-only strategy?
    • What are the potential hurdles of using an MS-only strategy?​

    THURSDAY AUGUST 22: 9:30 – 10:30 AM

    DIGITAL TRANSFORMATION & AI IN BIOPROCESS

    TABLE 1: Post Model Establishment: Meaningfully Implementing Models in Process Development
    Moderator: Terrence Dobrowsky, PhD, Head, Technology Development and Implementation, Takeda

    • What do you consider when deciding on entry points for modeling in process development?
    • How do you enable engagement and use of models in development workflows?
    • What does ‘in silico first’ mean to different stakeholders? 
    • What are the biggest hurdles when incorporating models directly into process control?

    TABLE 2: Digital Bioprocessing and Industry 4.0: How Far along Are We?
    Moderator: Mark Duerkop, CEO, Novasign GmbH

    • Critical evaluation of the current industrial evolution?
    • AI vs. mechanistic modeling: what to choose?
    • Workflow vs. data: where to invest?
    • Outlook—how AI will change the way of bioprocessing in the future?

     

    ADVANCES IN PURIFICATION & RECOVERY

    TABLE 4: Challenges and Opportunities in Membrane-Based Separations in Bioprocessing
    Moderator: Jian Ren, PhD, Principal Scientist, AbbVie

    • ​​Membrane-based separation techniques are essential in bioprocessing to enable clarification, virus filtration, UFDF, and sterile filtration etc.
    • There is strong demand for high performance membrane-based separations for high cell density culture, high throughput viral filtration, and high concentration formulations
    • Opportunities also arise in using membrane-based techniques for novel modes of separation, such as membrane chromatography

    TABLE 5: Alternative Approaches to Protein Affinity Chromatography
    Moderator: Jean-Francois P. Hamel, PhD, Lecturer, Chemical Engineering, Massachusetts Institute of Technology

    • Recent advances in non-affinity and mixed-mode chromatography
    • The format of these chromatography systems (e.g., packed-bed versus monolith)
    • Their applications in the analytical and process environments, such as for ionic and hydrophilic drugs, antibodies and proteins, alkaloids, oligonucleotides, and peptides. 

     

    CELL THERAPY MANUFACTURING

    TABLE 6: Process Development for TILs
    Moderator: Kathryn L Aron, PhD, Director, Process Development, Obsidian Therapeutics, Inc.

    • Optimization of TIL Isolation and Expansion Techniques
    • Manufacturing for Commercial Use
    • Improving TIL Efficacy through Genetic Engineering​

    TABLE 7: Promises and Challenges of Bioprocessing for PSC-Derived NK Cell Therapies
    Moderator: Allen Qiang Feng, PhD, Founder and CSO, HebeCell Corp.

    • Advancements in PSC Differentiation Protocols 
    • Overcoming Scale-Up Challenges
    • Regulatory and Safety Considerations​

    FORMULATION AND DELIVERY OF HIGH-CONCENTRATION PROTEINS AND NEW MODALITIES

    TABLE 8: Process Development and Manufacturing Considerations for Novel Modalities
    Bharathi Vellalore, PhD, Senior Scientist, Therapeutics Development and Supply, Janssen Pharmaceuticals

    • Scale-out vs scale-up for allogeneic and autologous cell therapies
    • Manufacturing considerations for lentivirus 

    NEXT GENERATION ANALYTICAL METHODS

    TABLE 9: Advancing Multi-Specific Molecules: Innovations and Challenges in Analytical Characterization
    Moderator: Hirsh Nanda, PhD, Director, Analytical Sciences, Janssen

    • Discuss the various platforms used in designing multi-specific proteins
    • Identify common challenges faced in the engineering and development of these molecules
    • Current analytical methods 
    • Emerging technologies 
    • Stage-appropriate methods