Key Sessions
KEYNOTE ADDRESS - How Digital Science Enables Integrated Development
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MAIN CONFERENCE DAY TWO - PST/PDT (Pacific Daylight, GMT-7)
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MAIN CONFERENCE DAY TWO - PST/PDT (Pacific Daylight, GMT-7)
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Streams
Formats
7:15am - 7:55am40 mins
Coffee and Continental Breakfast
7:55am - 8:00am5 mins
Conference Opening and Welcome
8:00am - 8:05am5 mins
Plenary Session
Chairperson’s Opening Remarks
8:00am - 9:15am75 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing
8:05am - 8:40am35 mins
Plenary Session
KEYNOTE ADDRESS - Collaborative Approaches Needed Between Functional Areas and Compromises Required to Effectively Speed Up and Streamline Development
8:40am - 9:15am35 mins
Plenary Session
KEYNOTE ADDRESS - How Digital Science Enables Integrated Development
9:15am - 9:55am40 mins
Spotlight Session
Rapid Cycling Chromatography and Single Pass Diafiltration for the Intensification of Downstream Processes
9:15am - 9:55am40 mins
Networking Break
Refreshment Break in the Exhibit & Poster Hall
9:55am - 10:00am5 mins
Track 1: Cell Line Development & Engineering
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 2: Cell Culture & Upstream Processing
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 3: Recovery & Purification
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 4: BioProcessing 4.0
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 5: Intensified & Continuous Processing
Chairperson’s Opening Remarks
9:55am - 10:00am5 mins
Track 6: Cell & Gene Therapy Manufacturing
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 7: Analytical & Quality
Chairperson's Opening Remarks
9:55am - 10:00am5 mins
Track 8: Phase-Appropriate Process Development
Chairperson’s Opening Remarks
9:55am - 12:00pm125 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
10:00am - 10:30am30 mins
Track 1: Cell Line Development & Engineering
Choosing the Best Clone: Quality, Speed and Diversity
10:00am - 10:30am30 mins
Track 2: Cell Culture & Upstream Processing
Tools to Enable Faster Initiation of Downstream Process Development Upon Receipt of Clarified Harvest
- David Brown, PhD - Scientist II, Downstream Process Development, KBI Biopharma
10:00am - 10:30am30 mins
Track 3: Recovery & Purification
Tools to Enable Faster Initiation of Downstream Process Development Upon Receipt of Clarified Harvest
- David Brown, PhD - Scientist II, Downstream Process Development, KBI Biopharma
10:00am - 10:30am30 mins
Track 4: BioProcessing 4.0
Digitally Transforming Genentech Process Development
10:00am - 10:30am30 mins
Track 5: Intensified & Continuous Processing
Assessing Environmental Impact Through Process Data Mining
10:00am - 10:30am30 mins
Track 6: Cell & Gene Therapy Manufacturing
Process Control strategies for Cell Therapy
10:00am - 10:30am30 mins
Track 7: Analytical & Quality
Improve physicochemical stability of therapeutic proteins
10:00am - 10:30am30 mins
Track 8: Phase-Appropriate Process Development
FEATURED PRESENTATION - Experiences from IND to BLA – Case Studies and Lessons Learned
10:30am - 11:00am30 mins
Track 1: Cell Line Development & Engineering
Cell Line Development with High Titer and Long Term Stability
10:30am - 11:00am30 mins
Track 2: Cell Culture & Upstream Processing
SUT Innovations – Bridging the Next Generation of Enabling Operations
10:30am - 11:00am30 mins
Track 3: Recovery & Purification
SUT Innovations – Bridging the Next Generation of Enabling Operations
10:30am - 11:00am30 mins
Track 4: BioProcessing 4.0
Soft Sensor Based on 2D-Fluorescence and MARS Modeling Enabling Real-Time Estimation of Biomass
10:30am - 11:00am30 mins
Track 5: Intensified & Continuous Processing
Economics and Ecology: The Impact of Water Reduction in Biotechnology
10:30am - 11:00am30 mins
Track 6: Cell & Gene Therapy Manufacturing
Design strategies of a commercial viral vector manufacturing platform
10:30am - 11:00am30 mins
Track 7: Analytical & Quality
Developability To Ensure Streamlined Manufacturing
10:30am - 11:00am30 mins
Track 8: Phase-Appropriate Process Development
Road to Accelerated Commercial Launch from a Single-Use Facility Perspective
11:00am - 11:30am30 mins
Track 1: Cell Line Development & Engineering
Implementing High-throughput and Automated Clonal Evaluation
11:00am - 11:30am30 mins
Track 2: Cell Culture & Upstream Processing
Intact Protein Mass Spectrometry of Cell Culture Harvest Guiding Clone Selection for Multi-Specific Antibodies
11:00am - 11:30am30 mins
Track 3: Recovery & Purification
Intact Protein Mass Spectrometry of Cell Culture Harvest Guiding Clone Selection for Multi-Specific Antibodies
11:00am - 11:30am30 mins
Track 4: BioProcessing 4.0
Application of Data Analytics to Raw Materials to Better Understand and Control Variation
11:00am - 11:30am30 mins
Track 5: Intensified & Continuous Processing
Innovative Manufacturing Strategies – What are the Drivers?
11:00am - 11:30am30 mins
Track 6: Cell & Gene Therapy Manufacturing
Instrumentation and mechanisms to drive efficient therapies
11:00am - 11:30am30 mins
Track 7: Analytical & Quality
FEATURED PRESENTATION: Demonstrating Comparability for an Accelerated Antibody Drug Conjugate with Post-Pivotal Process Changes
11:00am - 11:30am30 mins
Track 8: Phase-Appropriate Process Development
Case Study – mAb Late Stage Development to Enable an ADC Program
11:30am - 12:00pm30 mins
Track 1: Cell Line Development & Engineering
Using Octet for High-Throughput Early Clone Selection
11:30am - 12:00pm30 mins
Track 2: Cell Culture & Upstream Processing
Development of a second generation PlasmidSelect resin
11:30am - 12:00pm30 mins
Track 3: Recovery & Purification
Development of a second generation PlasmidSelect resin
11:30am - 12:00pm30 mins
Track 4: BioProcessing 4.0
Industry 4.0 – Taking the first step
11:30am - 12:00pm30 mins
Track 5: Intensified & Continuous Processing
Driving Value and Innovation in Upstream Technologies with The BioContinuum™ Intensified Seed Train Platform
11:30am - 12:00pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
AAV process development guidance based on cost modeling
11:30am - 12:00pm30 mins
Track 7: Analytical & Quality
On demand process analytics for cell therapy products: Bringing the power of Flow Cytometry to the manufacturing floor
11:30am - 12:00pm30 mins
Track 8: Phase-Appropriate Process Development
Integration of Cedex Technology for Standardized Cell Culture Monitoring Analytics in GMP Manufacturing
12:00pm - 1:00pm60 mins
Networking Luncheon in the Exhibit & Poster Hall
1:00pm - 1:05pm5 mins
Track 1: Cell Line Development & Engineering
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 2: Cell Culture & Upstream Processing
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 3: Recovery & Purification
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 4: BioProcessing 4.0
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 5: Intensified & Continuous Processing
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 6: Cell & Gene Therapy Manufacturing
Chairperson's Opening Remarks
1:00pm - 1:05pm5 mins
Track 7: Analytical & Quality
Chairperson’s Opening Remarks
1:00pm - 1:05pm5 mins
Track 8: Phase-Appropriate Process Development
Chairperson’s Opening Remarks
1:00pm - 2:40pm100 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
1:05pm - 1:35pm30 mins
Track 1: Cell Line Development & Engineering
Application of Pool Cell Lines Rather Than Clones To Reduce Time To Clinic:
1:05pm - 1:35pm30 mins
Track 2: Cell Culture & Upstream Processing
Cell Culture Process Controls, Novel Sensors and Real-Time Monitoring Methods: A Case Study from Genentech
- Sanket Dahotre - Engineer I, iLabs, Genentech
1:05pm - 1:35pm30 mins
Track 3: Recovery & Purification
Smaller and Faster – Using High Throughput PD to Develop and Qualify a Protein A Micro-Model
1:05pm - 1:35pm30 mins
Track 4: BioProcessing 4.0
TELECONFERENCE: Application of Automation and Robotics in Biomanufacturing
1:05pm - 1:35pm30 mins
Track 5: Intensified & Continuous Processing
Propagation of Process Disturbances in Continuous Integrated Biomanufacturing
1:05pm - 1:35pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Optimizing Viral Vector Production
1:05pm - 1:35pm30 mins
Track 7: Analytical & Quality
Connecting the Analytics with the Process and Not Having Disconnected Parts
1:05pm - 1:35pm30 mins
Track 8: Phase-Appropriate Process Development
Connecting the Analytics with the Process and Not Having Disconnected Parts
1:35pm - 2:05pm30 mins
Track 1: Cell Line Development & Engineering
Efforts To Achieve Therapeutic Protein Production with Improved Speed, Productivity and Product Quality while Significantly Reducing Costs
1:35pm - 2:05pm30 mins
Track 2: Cell Culture & Upstream Processing
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
1:35pm - 2:05pm30 mins
Track 3: Recovery & Purification
Rapid Release of TOX Material from Pilot Plant in < 3days
1:35pm - 2:05pm30 mins
Track 4: BioProcessing 4.0
Panel Discussion: Steps Toward Digital Transformation – Overcoming Setup, Data Management, Integration Solutions and Security Challenges
- Moritz von Stosch - Chief Innovation Officer, DataHow AG.
1:35pm - 2:05pm30 mins
Track 5: Intensified & Continuous Processing
Predictive & Mechanistic CEX Modeling Based Process Design for a Protein Therapeutic
1:35pm - 2:05pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Please move to another track
1:35pm - 2:05pm30 mins
Track 7: Analytical & Quality
Topic TBD
1:35pm - 2:05pm30 mins
Track 8: Phase-Appropriate Process Development
Topic TBD
2:05pm - 2:10pm5 mins
Track 1: Cell Line Development & Engineering
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 2: Cell Culture & Upstream Processing
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 3: Recovery & Purification
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 4: BioProcessing 4.0
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 5: Intensified & Continuous Processing
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 6: Cell & Gene Therapy Manufacturing
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 7: Analytical & Quality
Transition to Technology Workshops
2:05pm - 2:10pm5 mins
Track 8: Phase-Appropriate Process Development
Transition to Technology Workshops
2:10pm - 2:40pm30 mins
Track 1: Cell Line Development & Engineering
Total Cell Line Development – a holistic A-Z approach for scientists planning a cell line development lab.
2:10pm - 2:40pm30 mins
Track 2: Cell Culture & Upstream Processing
Facility-Fit Driven Development for a MAB Production Process
2:10pm - 2:40pm30 mins
Track 3: Recovery & Purification
Using column chromatography? Switch to Single Use Polishing AEX Membrane for Next Gen Downstream Processing
2:10pm - 2:40pm30 mins
Track 4: BioProcessing 4.0
Strategies for Bringing Cell and Gene Therapies to Market
2:10pm - 2:40pm30 mins
Track 5: Intensified & Continuous Processing
Intensification of upstream operations with automated perfusion
2:10pm - 2:40pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Technology Workshop 6
2:10pm - 2:40pm30 mins
Track 7: Analytical & Quality
Technology Workshop 7
2:10pm - 2:40pm30 mins
Track 8: Phase-Appropriate Process Development
Technology Workshop 7
2:40pm - 3:30pm50 mins
Refreshment Break in the Exhibit & Poster Hall
3:30pm - 4:00pm30 mins
Track 1: Cell Line Development & Engineering
Introducing Techniques Which Allows for Early Clone Identification
3:30pm - 4:00pm30 mins
Track 2: Cell Culture & Upstream Processing
Machine Learning In Bioprocess Development: A Journey From The Current Status To The Future
- Moritz von Stosch - Chief Innovation Officer, DataHow AG.
3:30pm - 4:00pm30 mins
Track 3: Recovery & Purification
The Challenges of Harvest and Downstream Processing for Bispecific Antibodies
3:30pm - 4:00pm30 mins
Track 4: BioProcessing 4.0
Machine Learning In Bioprocess Development: A Journey From The Current Status To The Future
- Moritz von Stosch - Chief Innovation Officer, DataHow AG.
3:30pm - 4:00pm30 mins
Track 5: Intensified & Continuous Processing
Digitalization of Biomanufacturing
3:30pm - 4:00pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Development of modern biologics and cell therapy products through global CMOs
3:30pm - 4:00pm30 mins
Track 7: Analytical & Quality
Streamlining Product Quality Attributes Characterization Using Ion Exchange Chromatography Coupled to Native Mass Spectrometry
3:30pm - 4:00pm30 mins
Track 8: Phase-Appropriate Process Development
Full Scale Production of a Therapeutic Neurotoxic Protein by Cell-Free Expression
3:30pm - 5:00pm90 mins
2 DAY TRAINING COURSE
Introduction to BioPharmaceutical Manufacturing – Cont’d
4:00pm - 4:30pm30 mins
Track 1: Cell Line Development & Engineering
Using Machine Learning/Automation For Clone Selection
4:00pm - 4:30pm30 mins
Track 2: Cell Culture & Upstream Processing
Big Data Analytics For Biopharmaceutical Manufacturing
4:00pm - 4:30pm30 mins
Track 3: Recovery & Purification
Transitioning from Chemistry Purification to Protein Purification for ASOs
4:00pm - 4:30pm30 mins
Track 4: BioProcessing 4.0
Big Data Analytics For Biopharmaceutical Manufacturing
4:00pm - 4:30pm30 mins
Track 5: Intensified & Continuous Processing
Data Science or PAT as Control Strategies for Continuous Biomanufacturing?
4:00pm - 4:30pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
Feedback from the Industry Alliance Partnership (IAP) & CIRM Partnership and Commercialization Opportunities
4:00pm - 4:30pm30 mins
Track 7: Analytical & Quality
Analytical Characterization of Therapeutic Proteins: A Case Study by Bristol-Myers Squibb
4:00pm - 4:30pm30 mins
Track 8: Phase-Appropriate Process Development
Topic TBD
4:30pm - 5:00pm30 mins
Track 1: Cell Line Development & Engineering
Panel Discussion: Cell Line Development: Considerations for the Future
4:30pm - 5:00pm30 mins
Track 2: Cell Culture & Upstream Processing
Making Better Decisions With Data: How We Are Using Models To Improve Outcomes In Process Development And Manufacturing
4:30pm - 5:00pm30 mins
Track 3: Recovery & Purification
Applying Existing Chromatographic and Electrophoretic Methods to Characterize and Release Antibodies and Antibody Drug Conjugates (Located in Mission City M3)
4:30pm - 5:00pm30 mins
Track 4: BioProcessing 4.0
Making Better Decisions With Data: How We Are Using Models To Improve Outcomes In Process Development And Manufacturing
4:30pm - 5:00pm30 mins
Track 5: Intensified & Continuous Processing
Multivariate process monitoring along with PAT for bioprocessing manufacturing for process performance and quality attributes
4:30pm - 5:00pm30 mins
Track 6: Cell & Gene Therapy Manufacturing
PANEL: CMO landscapes for new product initiatives: Novel outsourcing models
4:30pm - 5:00pm30 mins
Track 7: Analytical & Quality
Polysorbate 20 As An Effective Mobile Phase Modifier in Size Exclusion Chromatography
4:30pm - 5:00pm30 mins
Track 8: Phase-Appropriate Process Development
Cell Line Development for Multi-specific Antibodies Guided by High Throughput Mispairing Screening of Harvest
5:00pm - 6:00pm60 mins
BPI WEST Exhibit Hall Reception
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