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March 14-17, 2022
San Diego Convention CenterSan Diego, California
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DAY TWO - PST/PDT (Pacific Daylight, GMT-7)

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DAY TWO - PST/PDT (Pacific Daylight, GMT-7)

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10:00am - 10:05am5 mins
Opening Remarks - Live
    10:05am - 10:25am20 mins
    Plenary Session
    Keynote Address - Live - Innovate to Transform - From Good to Great Biomanufacturing
    • Thomas Seewoester, Ph.D. - Vice President, External Operations, Amgen, Inc.
    10:30am - 11:00am30 mins
    Plenary Session
    Panel: “Looking to the Future” - How Digital Innovation Will Change Our Industry
    • Lynne Frick - Co-Head, Biologics Franchise, Resilience and Co-Executive Director, The BioInnovation Group
    • Rick St. John, Ph.D. - Head of Digital Sciences, Genentech, Inc
    11:05am - 11:25am20 mins
    Track 1: Cell Line Development & Engineering
    Mitigation of Antibody Sulfation by CHO Host Selection and Inhibitor Supplementation
    • Ren Liu - Principal Scientist, Merck
    11:05am - 11:25am20 mins
    Track 2: Cell Culture
    Raw Material Risk Mitigation & Control Strategies to Reduce Raw Material Variability
    • Thomas Matthews - Scientist II, Biogen
    11:05am - 11:25am20 mins
    Track 3: Recovery & Purification
    Evolution of Antibodies and the Related Downstream Challenges
    • Sanchayita Ghose, PhD - Executive Director, Global Downstream Bioprocess Development, Biologics Development, BMS
    11:05am - 11:25am20 mins
    Track 4: Manufacturing Strategy & Bioprocessing 4.0
    Operational Excellence: Strategies for Aligning Continuous Process Operations with Emerging Standards
    • Tom Ransohoff - Co-Head Biologicals Franchise, Resilience
    11:05am - 11:25am20 mins
    Track 5: Intensified & Continuous Processing
    Operational Excellence: Strategies for Aligning Continuous Process Operations with Emerging Standards
    • Tom Ransohoff - Co-Head Biologicals Franchise, Resilience
    11:05am - 11:25am20 mins
    Track 6: Cell & Gene Therapies
    Novel Filtration Systems & Cell Processing in Automated Closed Systems for Autologous Therapies
    • Margarida Serra - Head of Stem Cell Bioengineering Lab, iBET - Instituto de Biologia Experimental e Tecnológica
    11:05am - 11:15am10 mins
    Live Labs
    Single-Step Column Purification for H1N1 Virus Using Nuvia HP-Q AEX Chromatography
    • Sharon Bola - Global Product Manager, Bio-Rad Laboratories
    11:15am - 11:25am10 mins
    Live Labs
    The AccuFlux® Integrity Tester Saves Valuable Operator and Manufacturing Time
    • Kyle Weeks - Product Automation Controls Engineer, Meissner Filtration Products
    11:25am - 11:35am10 mins
    Live Labs
    Improving Tech Transfer from Research to Development
    • Kate Quigley - Product Marketing Lead, Benchling
    11:30am - 11:50am20 mins
    Track 1: Cell Line Development & Engineering
    Accelerating the Delivery of Purified Antibodies in Early Discovery Through the Utilization of a Novel High Throughput, One-Step Transient to Stable Cell Line Generation Process
    • Marina Alvi - Senior Research Scientist, Lilly Biotechnology Center-San Diego, Eli Lilly
    11:30am - 11:50am20 mins
    Track 2: Cell Culture
    Asparagine Metabolism and its Importance for the Development of Feeds for High Producing Cell Lines During Fed-Batch Bioreactor Production
    • Sandra Bennun Serrano - Staff Engineer, Regeneron
    11:30am - 11:50am20 mins
    Track 3: Recovery & Purification
    Recovery and Purification Processing for Bispecific Antibody Production
    • Ji Zheng, PhD - Director, Biologics Development, Product Development, Global Product Supply, Bristol-Myers Squibb
    11:30am - 11:50am20 mins
    Track 4: Manufacturing Strategy & Bioprocessing 4.0
    Digital Transformation: How to make the cultural shift
    • Rick St. John, Ph.D. - Head of Digital Sciences, Genentech, Inc
    11:30am - 11:50am20 mins
    Track 5: Intensified & Continuous Processing
    Standards, Best Practices and Guidance for Continuous Bioprocessing
    • Kurt Brorson, PhD - Vice President, Technical, Parexel International
    11:30am - 11:50am20 mins
    Track 6: Cell & Gene Therapies
    High Reliability and High Confidence Genome Scale Engineering of T-Cells
    • Tanya Warnecke - CTO, Artisan Bio
    11:35am - 11:45am10 mins
    Live Labs
    The NEW OsmoTECH XT Single Sample Osmometer: In a class of its own, solving some of your toughest QC testing challenges
    • Shweta Nair - Sr. Product Manager, Biotechnology, Advanced Instruments, LLC
    11:45am - 11:55am10 mins
    Live Labs
    Two-Step Purification of Novel Mouse Monoclonal Antibody from Hybridoma Cell Line
    • Jukka Kervinen PhD - Scientist, Applications Group Manager, TOSOH BIOSCIENCE LLC
    11:55am - 12:15pm20 mins
    Track 1: Cell Line Development & Engineering
    A New Data-Driven Workflow for Cell Line Development
    • Duncan Borthwick - Global Marketing Manager, Solentim
    11:55am - 12:15pm20 mins
    Track 2: Cell Culture
    High Throughput Upstream Processing and Quality Analysis via Microfluidic Capillary Electrophoresis
    • James Geiger, PhD - Field Application Scientist, PerkinElmer
    11:55am - 12:15pm20 mins
    Track 3: Recovery & Purification
    Harnessing IMAC to Enable an Immobilized Enzyme Cascade for the Synthesis of Islatravir
    • Jacob H. Forstater, PhD - Associate Principal Scientist, Merck Process Research & Development, Merck Research Laboratories
    11:55am - 12:15pm20 mins
    Track 4: Manufacturing Strategy & Bioprocessing 4.0
    The Evolution of AI - Accessibility for Everyone. How Will Artificial Intelligence Help Biotech Scientists?
    • Hemant Garg - Product Manager Analytics, MilliporeSigma
    • Philippe Eberhard - IT Architect, MilliporeSigma
    11:55am - 12:15pm20 mins
    Track 5: Intensified & Continuous Processing
    Twin-column continuous chromatography for polishing applications – removing critical barriers in manufacturing
    • Thomas Müller-Späth, PhD - Chief Technology Officer, YMC Process Technologies
    11:55am - 12:15pm20 mins
    Track 6: Cell & Gene Therapies
    On The Importance Of Monitoring Both Transfection And Transduction Efficiencies In Cell Therapy Development
    • Derek C. Lenz - Senior Marketing Manager, Biopharma, Beckman Coulter Life Sciences
    12:20pm - 12:40pm20 mins
    bioCERTIFIED: Turn Your Quality Management System into a Competitive Advantage
    • Jigisha Patel - VP, Regulatory Compliance & Technical Services, Spectrum Chemical Mfg. Corp.
    12:45pm - 1:10pm25 mins
    Roundtable Discussions
      1:15pm - 1:35pm20 mins
      Track 1: Cell Line Development & Engineering
      KEYNOTE: Reimagining Yeast for Monoclonal Antibody Production
      • Chris Love - Professor of Chemical Engineering, MIT
      1:15pm - 1:35pm20 mins
      Track 2: Cell Culture
      Utilizing Multi-Omics to Drive Upstream Process Changes to Mitigate Problematic HCPs
      • Taylor Forte - Engineer, Biogen
      1:15pm - 1:35pm20 mins
      Track 3: Recovery & Purification
      Intensification of Buffer Platforms: Optimizing Process Development and Manufacturing Operations
      • Victor Pasquier - DSP Technology Innovation Specialist, Merck
      1:15pm - 1:35pm20 mins
      Track 4: Manufacturing Strategy & Bioprocessing 4.0
      The role of Hybrid modeling in bioprocess digitalization – Moving from a data-centric to a knowledge-centric approach
      • Moritz von Stosch - Chief Innovation Officer, DataHow AG.
      1:15pm - 1:35pm20 mins
      Track 5: Intensified & Continuous Processing
      Intensification of Buffer Platforms: Optimizing Process Development and Manufacturing Operations
      • Victor Pasquier - DSP Technology Innovation Specialist, Merck
      1:15pm - 1:35pm20 mins
      Track 6: Cell & Gene Therapies
      Platform Development in AAV Manufacturing: Cost and Timeline impact on clinical development
      • Andy Holt - Executive Vice President, Commercial Development - Manufacturing, Asklepios BioPharmaceutical, Inc. (AskBio), USA
      1:15pm - 2:30pm75 mins
      Live Labs
      5-10 minute live demos and presentations focusing on the most innovative technologies, equipment and services to hit today's biopharmaceutical market
        1:40pm - 2:00pm20 mins
        Track 1: Cell Line Development & Engineering
        KEYNOTE: Critical Considerations for Recombinant Protein Process Development
        • Somen Nandi - Adjunct Professor, University of California, Davis
        1:40pm - 2:00pm20 mins
        Track 2: Cell Culture
        Qualification of Scale Up and Scale Down Models for Clinical and Commercial Manufacturing
        • Gurpreet Tahim - Research Associate, Seagen
        1:40pm - 2:00pm20 mins
        Track 3: Recovery & Purification
        Lab Automation Enhancements for Faster Downstream Process Development
        • Juan Cueva - Associate Scientist III, Process Biochemistry, Biogen
        1:40pm - 2:00pm20 mins
        Track 4: Manufacturing Strategy & Bioprocessing 4.0
        Applying data-driven models in biopharmaceutical manufacturing to improve real-time decision-making
        • Chris Garvin - Director, Digital Manufacturing, Amgen
        1:40pm - 2:00pm20 mins
        Track 5: Intensified & Continuous Processing
        Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
        • William Napoli - Scientist, Sanofi
        1:40pm - 2:00pm20 mins
        Track 6: Cell & Gene Therapies
        CMC Platform Development and Late Stage Considerations for AAV Gene Therapy Products
        • James Warren - VP Pharmceutical Development, Ultragenyx
        2:05pm - 2:35pm30 mins
        Track 1: Cell Line Development & Engineering
        PANEL: Utilizing an Assortment of Cell Line Types for Complex Biopharmaceutical Production
        • Chris Love - Professor of Chemical Engineering, MIT
        • Susan Sharfstein, PhD - Professor of Nanobioscience, SUNY Polytechnic Institute
        • Ren Liu - Principal Scientist, Merck
        • Somen Nandi - Adjunct Professor, University of California, Davis
        2:05pm - 2:35pm30 mins
        Track 2: Cell Culture
        From Early Research to Pre-Clinical Molecules: Development of a CHO based transient / stable pool platform addressing the needs of the deliverable
        • Saurabh Sen - Associate Director, Cell Line Development, Sanofi
        2:05pm - 2:35pm30 mins
        Track 3: Recovery & Purification
        Panel: Continuous Manufacturing: We’ve heard about for so long – What is really going on!
        • Tom Ransohoff - Co-Head Biologicals Franchise, Resilience
        • Kurt Brorson, PhD - Vice President, Technical, Parexel International
        • Huanchun Cui - Executive Director, Continuous Manufacturing and Process development, Resilience
        • Marc Bisschops, Ph.D. - Technology Director, Continuous Processing, Pall Life Sciences, Holland
        2:05pm - 2:35pm30 mins
        Track 4: Manufacturing Strategy & Bioprocessing 4.0
        The Rapid Adoption of Intelligent Manufacturing & Pharma 4.0 during COVID
        • Angelo Stracquatanio - CEO & Co-founder, Apprentice.io
        2:05pm - 2:35pm30 mins
        Track 5: Intensified & Continuous Processing
        Panel: Continuous Manufacturing: We’ve heard about for so long – What is really going on!
        • Tom Ransohoff - Co-Head Biologicals Franchise, Resilience
        • Kurt Brorson, PhD - Vice President, Technical, Parexel International
        • Huanchun Cui - Executive Director, Continuous Manufacturing and Process development, Resilience
        2:05pm - 2:25pm20 mins
        Track 6: Cell & Gene Therapies
        Comprehensive Characterization of Viral Vector Particles via CE/UV and LC/MS
        • Christopher Colangelo, Ph.D., MBA - Biopharma Business Development Leader, Agilent Technologies, Inc.
        2:35pm - 3:00pm25 mins
        Networking Time – Schedule Meetings, Visit Exhibit Booths & Poster Rooms
          3:00pm - 4:00pm60 mins
          Diversity, Equity and Inclusion Discussion - Expand Your Market Success, Build Talent Pipelines, Foster Existing Staff Growth
          • Maria Pineda, Ph.D. - Co-Founder & CEO, Envisagenics
          • Stephen Wing - Sr. Product Manager, Analytical & Logistical Services, BioProcessing Process Solutions, MilliporeSigma
          • Rebecca Harris - Associate Director, Human Capital, Enspira
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