対面でのブレイクアウトディスカッション

業界の専門家や同僚と、研究の進捗状況・動向、直面している課題について、綿密なディスカッションに参加しましょう！インタラクティブディスカッショングループは、潜在的な共同研究者とのネットワーク構築に不可欠な役割を果たし、研究事例の共有、グループで問題解決に取り組む機会を提供する場となります。

Tuesday, August 11th | 5:40 - 6:30 pm

Cell Line Development & Engineering

TABLE: AI in Cell Line Development - Enhancing Expression and Manufacturability of CHO Cells
Moderator: Susan Sharfstein, PhD, Professor of Nanoscale Science and Engineering, University at Albany

• Predictive clone selection and productivity modeling
• AI-guided genetic engineering of CHO cells
• Linking cell line genotype to manufacturability
• Building robust training data: integrating CLD, bioprocess and developability data

Formulation Stability & Delivery

TABLE: Emerging Drug Delivery Technologies and Devices, including Patient-Centric and 3D-Printed Systems
Kruti Soni, PhD, Senior Scientist, Biologics Drug Product Development, Biogen

• Convergence of high-concentration biologics and device innovation
• Patient-centric delivery paradigms beyond self-injection
• 3D printing and additive manufacturing for personalized drug delivery
• Smart and adaptive drug delivery systems
• Translation to clinic: challenges due to system complexity at both technical and regulatory level

Intensified & Continuous Bioprocessing

TABLE: End-to-End Continuous Bioprocess and Integrated Facility Design
Moderator: William Whitford, Founder, Oamaru BioSystems

• Fully continuous bioprocessing: current perspectives on end-to-end continuous as a goal for bioprocessing operations
• Facility design philosophy: suite optimization for continuous operation versus modular, flexible architectures enabling alterable or hybrid deployments
• Holistic process/facility co-design: integration of continuous unit operations with new manufacturing modalities, facility infrastructures, and emerging equipment control platforms 
• Adoption challenges: technical, organizational, and regulatory barriers to continuous manufacturing and recent advanced modeling, control, and automations

Analytical Intelligence

TABLE: Designing Protein Therapeutics with Developability in Mind: Bridging Early Molecular Insights to CMC Outcomes
Moderator: Krishna D. Bharadwaj Anapindi, PhD, Senior Scientist, Biology, Gilead Sciences Inc.

• Incorporating developability considerations early in discovery, including identifying risks related to aggregation, hydrophobicity, viscosity, stability, and expression before nomination
• Navigating trade-offs between functional performance and molecular robustness, particularly in advanced formats such as bispecific antibodies and antibody drug conjugates (ADCs)
• Leveraging predictive and high-throughput approaches, including computational tools and machine learning, alongside biophysical screening to inform candidate selection
• Linking early-stage molecular assessment with downstream manufacturing considerations, including implications for purification, formulation, and scalability
• Establishing practical, stage-appropriate criteria for progressing candidates that balance efficacy, safety, and developability

Oligonucleotide and Peptide CMC and Manufacturing

Table: CMC Strategies for Oligonucleotide and Conjugated Therapies
Moderator: Robert Dream, PhD, Managing Director, HDR Co. LLC

• Discuss the unique CMC challenges associated with oligonucleotide therapeutics and emerging conjugated modalities, including antibody oligonucleotide conjugates
• Explore critical considerations for synthesis, conjugation, purification, and analytical characterization
• Highlight strategies to control product quality, impurity profiles, potency, stability, and batch consistency
• Examine how evolving regulatory expectations are shaping CMC development for increasingly complex oligonucleotide-based therapies