Key Sessions
Robert Herbst
KEYNOTE: Success with External Manufacturing
Immunogen
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Main Conference Day 3 - PST/PDT (Pacific Daylight, GMT-7)
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Main Conference Day 3 - PST/PDT (Pacific Daylight, GMT-7)
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8:00am - 8:25am
Coffee and Registration
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Recovery & Purification
Manufacturing Strategy & Bioprocessing 4.0
Cell and Gene Therapy Manufacturing
8:25am - 8:30am
Chairperson's Opening Remarks
8:30am - 9:00am
Stable Cell Line for VLPs in Vaccine Production
- Yi Liu - Scientist III and Team Lead, Cell Line Development Vaccine Production Program, VRC/NIAID/NIH
9:00am - 9:30am
Next Generation Cell Line Development Workflows - A Focus on Biosensors & Automation
- Jishna Ganguly - Expert Scientist, GSK
9:30am - 10:00am
Scientific Track Presentation
8:25am - 8:30am
Chairperson's Opening Remarks
8:30am - 9:00am
Keynote Address: Overcoming CMC Challenges in the Development of an Oncolytic Virus
- Ingo Gorr - Director, Head of Early Stage Bioprocess Development (USP & DSP), Boehringer Ingelheim
9:00am - 9:30am
Accelerated Tech Transfer and Scale Up for AAV Production Using Sf9 and Baculovirus System
9:30am - 10:00am
Scientific Track Presentation
8:25am - 8:30am
Chairperson's Opening Remarks
8:30am - 9:00am
Continuous Removal of HCPs
- Irina Ramos - Director, AstraZeneca
9:00am - 9:30am
Interactome to Explain Host Cell impurities
- Alois Jungbauer - Professor, Dept. of Biotechnology, University of Natural Resources and Applied Life Sciences
9:30am - 10:00am
Scientific Track Presentation
8:25am - 8:30am
Chairperson's Opening Remarks
8:30am - 9:00am
Single Use Assembly Defects and Investigation - Experience From A New Single Use Clinical Biologics Manufacturing Facility
- Roshan Shrestha - Single Use Expert (CSC) and DS Tech Team Lead (Global), Genentech
9:00am - 9:30am
KEYNOTE: Success with External Manufacturing
- Robert Herbst - VP, Technical Operations, Immunogen
9:30am - 10:00am
Scientific Track Presentation
8:25am - 8:30am
Chairperson's Opening Remarks
8:30am - 9:00am
Keynote Presentation: Next Generation Process Development and Manufacturing for Cell and Gene Therapies – Improving Efficiencies and Reducing Cost of Goods
- Sam Yaghmour - Head of Process Development – Gene therapy, Cell & Gene Therapies -TRD, San Diego GDD Site Head, Novartis
9:00am - 9:30am
Navigating Through Clinical and Commercial Manufacturing Strategies
- Nitin Garg - Sr. Director, CMC, Gene Therapy, PTC Therapeutics
9:30am - 10:00am
Scientific Track Presentation
10:00am - 11:00am
Morning Break
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Recovery & Purification
Manufacturing Strategy & Bioprocessing 4.0
Cell and Gene Therapy Manufacturing
11:00am - 12:00pm
Panel Discussion: How many cell lines should you have?
- Sampath Kumar - Senior Director and Head of Cell Line Development, Biologics Process Development, Takeda Pharmaceuticals
- Saurabh Sen - Associate Director, Cell Line Development, Genomic Medicine Unit CMC, Sanofi
12:00pm - 12:30pm
Scientific Track Presentation
11:00am - 11:30am
Cell Therapy Manufacturing Process Analytical Utility of Raman Spectroscopy
- Jamie Piret, Sc.D. - Professor, The University of British Columbia
11:30am - 12:00pm
Continuous Improvement in Bispecifics Manufacturing: Advantages and Disadvantages of 2-Cell Vs. 1-Cell Culture Process
12:00pm - 12:30pm
Scientific Track Presentation
11:00am - 11:30am
Achieving Fully Continuous Downstream
- Tim Wanek - Director, Just-Evotec Biologics
11:30am - 12:00pm
Intensified Polishing Steps
- Andrew Maloney - Principal Scientist, Amgen
12:00pm - 12:30pm
Scientific Track Presentation
11:00am - 12:00pm
Panel Discussion: Post Partnership Successful Relationships with CDMO and Biopharma
- Dharti Kothari - Associtae Director, External Manufacturing, CMC, Bolt Biotherapeutics
- Elizabeth Puck - Engineering Specialist, External Manufacturing Biologics DS, Merck
12:00pm - 12:30pm
Scientific Track Presentation
11:00am - 11:30am
Managing Critical Starting Materials for Gene Therapy Manufacturing
- Sarah Blackmore - Senior Manager Gene Therapy External Manufacturing, Sarepta Therapeutics
11:30am - 12:00pm
High-Throughput Sequencing: A Multi-Attribute Platform for Characterization of rAAV Drug Product
- Huimin Tao - Associate Director, Analytical Development and Operations, Novartis Gene Therapies
12:00pm - 12:30pm
Scientific Track Presentation
12:30pm - 1:30pm
Lunch
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Recovery & Purification
Manufacturing Strategy & Bioprocessing 4.0
Cell and Gene Therapy Manufacturing
1:30pm - 2:00pm
Rapid development of trimeric SARS-CoV-2 spike-based vaccine candidates using stable CHO pools
- Yves Durocher, PhD - Section Head, Mammalian Cell Expression - NRC Human Health Therapeutics Research Center, National Research Council Canada
2:00pm - 2:30pm
CLD AstraZeneca Case Study
- Lina Chakrabarti - Associate Director, R & D, Astrazeneca
2:30pm - 3:00pm
When Will We Have a Clone?
- Ren Liu - Principal Scientist, Merck
- Stephanie Rieder - Principal Research Scientist, Process Sciences, CHO Cell Line Development, AbbVie, Inc.
1:30pm - 2:00pm
What does a Cell Need for Efficient Protein Secretion: Deciphering, Modeling, and Augmenting the CHO Machinery
- Nathan Lewis, PhD - Professor, University of California, San Diego
2:00pm - 2:30pm
Feedback-Responsive Cell Factories for Biomanufacturing
- Laura Segatori - Professor, Rice University
2:30pm - 3:00pm
Building One Block at a Time Toward Complex Biologics Using Cell-Free Protein Synthesis Process
1:30pm - 2:00pm
Design and Development of a Purification Platform to Meet the Challenges of a Diverse Therapeutic Antibody Pipeline and Next Generation Manufacturing
- Ludivine Profit - DSP Scientist, Sanofi
2:00pm - 2:30pm
Applying a Platform mAb Approach to Multi-Specifics
- Leslie Wolfe, PhD - Director, Downstream Process Development, KBI Biopharma
2:30pm - 3:00pm
Analyzing the Impact of Linker-Payload Technologies on Early-Phase Development
1:30pm - 2:00pm
Implementing Process Improvement & Standardization Initiatives Post-Stakeholder Acceptance
- Eric Doerr - Senior Specialist for Product & Process (SPP), Sanofi
2:00pm - 2:30pm
Vegan Cheese – Essential ingredients to set up a scalable and economic manufacturing process
- Christoph Herwig - Senior Scientific Advisor, Lisalis GmbH
2:30pm - 3:00pm
Adjusting Your Platform To Accommodate Complex Proteins
1:30pm - 2:00pm
Apply Knowledge of the Structure-Function Relationship of scAAV in Control Strategy for Late-Stage Process Change
- Wei Zhang - Director, Analytical Development, Ultragenyx Gene Therapy
2:00pm - 2:30pm
Potency Assay: During BLA/MAA Review and After Product Approval
- Yan Zhi - Director, Cell and Gene Therapy Product Owner, Process Engineering, CSL Behring
2:30pm - 3:00pm
Application of AI and Machine Learning in Cell and Gene Therapy Process Development and Manufacturing
3:00pm - 3:05pm
End of Event
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