分组讨论

您可以与业界专家和同行企业深入探讨研究进展和面临的挑战。

互动讨论小组在与未来潜在合作者建立人脉上发挥着不可或缺的作用。同时这也是您可以与参与者彼此分享研究成果、与同行交流发想并共同解决问题的宝贵机会。

该单元仅以面对面的型式进行。

8月20日星期二 10:45 - 11:30 AM

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

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

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

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

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.

TABLE 9: Leveraging Thought Leadership & AI on Social Media for Scientific Advancement
Moderator: Nandini Kashyap, M.Pharm., Senior Director, Conferences and Social Media Strategy, Cambridge Innovation Institute

Harnessing AI Tools for Literature Research, Content Planning, Creation and Distribution
Leverage Publications, Speaking Opportunities, and Social Media to Increase Influence and Search Rankings
Forming Meaningful Connections and Building and Nurturing Scientific Communities both Online and In-Person
Overcoming Challenges and Barriers to Adoption

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

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日星期四 9:30 - 10:30 AM

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

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.

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

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

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

* 活动内容有可能不事先告知作更动及调整。

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