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8月20日火曜日 10:45 - 11:30 AM

CELL LINE ENGINEERING & CELL CULTURE OPTIMIZATION

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?

8月22日木曜日 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?

TABLE 3: In-house vs Off-the-Shelf Solutions for a Digital R&D Ecosystem
Moderator: Victor Sanchez Tarre, PhD, Dir Data Science, Mfg Science & Technology, MeiraGTX

• Factors to be considered when deciding on building an in-house software solution vs. off-the-shelf offerings
• Tools to build a successful digital ecosystem-from specific code packages to ELN and data exploration platforms of choice
• Infrastructure supporting the functions from Data Engineering like data capture, data storage, and ETL pipelines; to Data Science like model versioning, data exploration, and advanced analytics
• Challenges-assay nomenclature harmonization, standardization of data capture and data processing workflows, and strategies to routinely generate FAIR data

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