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Antibody Manufacturing Xchange - Boston - 2026

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  1. Quality Control & Characterization
    • Quality Control & Characterization
    Challenges of developing stable high‐concentration formulations for novel biologic modalities
    What issues are you faced with when developing high concentration formulations for novel modalities? ...
    Dmitry Gumerov
    Dmitry Gumerov, Senior Director, CMC, Pharmaceutical Sciences and Technology - Visterra Inc. (Otsuka company)
  2. Quality Control & Characterization
    • Quality Control & Characterization
    Detecting variations in glycan profiles that affect efficacy or immunogenicity
    What level of glycan shift is considered clinically meaningful after pivotal trials, and how should ...
    Feny Gunawan
    Feny Gunawan, Senior Director of CMC - Mediar Therapeutics
  3. Formulation & Stability
    • Formulation & Stability
    Choosing buffers and stabilizers that prevent aggregation and degradation
    What criteria are used to select buffers/additives during mAb purification?  Are they driven by proc ...
    Satish Singh
    Satish Singh, Vice President, Drug Product Development - BioCryst Pharmaceuticals
  4. Downstream Processing & Purification
    • Downstream Processing & Purification
    Ensuring minimal HCP contamination to meet regulatory requirements
    What are the primary sources of host cell protein (HCP) contamination throughout the manufacturing p ...
  5. Downstream Processing & Purification
    • Downstream Processing & Purification
    Poster Presentation: On-Demand Customization of Buffer Solutions for Cell Culture and Bioprocessing
    Therapeutic antibody modalities continue to advance, as do the needs for reliable sourcing and timel ...

    Boston BioProducts

    Karan Sharma
    Karan Sharma, Chief Executive Officer - Boston BioProducts
  6. Quality Control & Characterization
    • Quality Control & Characterization
    Resolving acidic or basic variants that may influence stability or bioactivity
    Which acidic and basic variants are present, and what are their underlying root causes (e.g., deamid ...
  7. Cell Line Development
    • Cell Line Development
    Balancing productivity with quality: Are we reaching the limits of cell line optimisation?
    Are current cell line optimisation strategies approaching their biological or technological limits? ...
  8. Quality Control & Characterization
    • Quality Control & Characterization
    Poster Presentation: Establishing reliable in vitro assays for antibody activity
    Establishing reliable in vitro assays for antibody activity is fundamental to demonstrating product ...
  9. Formulation & Stability
    • Formulation & Stability
    Accurately forecasting long-term stability from accelerated data
    How reliably can accelerated stability studies predict long-term product behavior under real-time co ...
  10. Formulation & Stability
    • Formulation & Stability
    Improving the accuracy of long-term stability predictions using accelerated degradation data
    What study setup and design considerations should be taken into account, including understanding the ...
    James Kranz
    James Kranz, Vice President & Head of CMC - Compass Therapeutics
  11. Upstream Development
    • Upstream Development
    Have we reached the limit on codon optimization?
    What are the real ceilings of codon design? From coding sequence optimization to full transcript des ...

    Converge Bio

    Eyal Weinstock
    Eyal Weinstock, Gene Expression Optimisation (GEO) Team Leader - Converge Bio
  12. Upstream Development
    • Upstream Development
    How can we accomplish early upstream development while racing to FIH?
    What aspects of a process can be established prior to clone selection or stability?  How early can w ...
    Rustin Shenkman
    Rustin Shenkman, Director, Internal Cell Culture Development & Manufacture - Kiniksa Pharmaceuticals
  13. Formulation & Stability
    • Formulation & Stability
    Poster Presentation: Preventing loss of activity or aggregation during storage and shipping
    Preventing loss of activity or aggregation during storage and shipping is essential to maintain the ...
  14. Upstream Development
    • Upstream Development
    Poster Presentation: Maintaining consistent growth and antibody quality from lab-scale to commercial-scale bioreactors
    Maintaining consistent cell growth and antibody quality during scale-up from lab-scale to commercial ...
  15. Cell Line Development
    • Cell Line Development
    Poster Presentation: Balancing productivity with quality: Are we reaching the limits of cell line optimisation?
    Balancing productivity and product quality remains a central challenge in biopharmaceutical manufact ...
  16. Downstream Processing & Purification
    • Downstream Processing & Purification
    Separating aggregates and fragments without reducing yield or affecting stability
    How can optimized chromatographic techniques such as SEC or IEX be employed to effectively distingui ...
    Deborah Moore-Lai
    Deborah Moore-Lai, Vice President of Protein Sciences - ProFound Therapeutics
  17. Cell Line Development
    • Cell Line Development
    From lab to manufacturing: How do we ensure cell lines are adaptable to evolving processes at scale?
    How can we ensure consistency in genetic integrity when implementing updated or intensified processe ...
    Christina Alves
    Christina Alves, Head of US Biologics Process Development - Takeda
  18. Upstream Development
    • Upstream Development
    Developing a high-throughput early developability package to support the pipeline and AI model training
    How can we meet the growing demand for early developability assessment across expanding pipelines? W ...
    Gilad Kaplan
    Gilad Kaplan, Director of Protein Analytics and Developability for Biologics Engineering, R&D team lead - AstraZeneca
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    Spotlight Presentation: Speed Without Compromise: Rapid High-Concentration Formulation Screening and Tox Batch Delivery from a Single Clone Within 4 Months
    Spotlight Presentation: Speed Without Compromise: Rapid High-Concentration Formulation Screening and Tox Batch Delivery from a Single Clone Within 4 Months
    Biopharma innovators face increasing pressure to advance biologic drug candidates to IND rapidly wit ...
    Leon Tian
    Leon Tian, Director of US Project Management - ProBio
  20. Cell Line Development
    • Cell Line Development
    Cell line development strategies towards overcoming multispecific expression challenges
    What attributes make multispecific antibodies a promising emerging class of therapeutic modalities? ...
    Jack Scarcelli
    Jack Scarcelli, Senior Director, Head of Cell Line Development - Sanofi
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    Drinks-Canape Reception
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    Afternoon Refreshments
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    1-2-1 Meetings / Networking Break
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    1-2-1 Meetings / Networking Break
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    Networking Lunch
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    Morning Refreshments
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    1-2-1 Meetings / Networking Break
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    1-2-1 Meetings / Networking Break
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
    Opening Address & Keynote Presentation: Applying Artificial Intelligence in Cell Culture Media Development for Antibody Production
    Opening Address & Keynote Presentation: Applying Artificial Intelligence in Cell Culture Media Development for Antibody Production
    Cell culture media development for antibody production is beginning to incorporate artificial intell ...
    Ben Borgo
    Ben Borgo, VP/GM, Cell Culture & Cell Therapy, Bioproduction - Thermo Fisher Scientific
    • Cell Line Development
    • Upstream Development
    • Downstream Processing & Purification
    • Formulation & Stability
    • Quality Control & Characterization
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