Key Sessions
Brian Recchione
KEYNOTE: Success with External Manufacturing
ImmunoGen
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Main Conference Day 3 (Exhibit Hall Open 9:45am-1:30pm) - PT (Pacific Time, GMT-08:00)
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Main Conference Day 3 (Exhibit Hall Open 9:45am-1:30pm) - PT (Pacific Time, GMT-08:00)
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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
Development of Stable Pool Expression Platform in HEK293 Cells
- Yi Liu - Scientist III and Team Lead, Cell Line Development Vaccine Production Program, VRC/NIAID/NIH
9:00am - 9:30am
Next Generation Cell Line Analytics
- YenRu Pan - Senior Research Scientist II (Associate Director), Gilead Sciences
9:30am - 10:00am
C.STATION: End-to-end automation for generating stable cell lines for the development of advanced therapeutics
- Erica Squires - Western Regional Manager, BioPharma, CYTENA GmbH
8:25am - 8:30am
Chairperson's Opening Remarks
- Brandon Downey - Principal Engineer, R&D, Lonza
8:30am - 9:00am
Keynote Address: Unveiling success factors in developing a scalable manufacturing process for an oncolytic virus
- Ingo Gorr - Head of Therapeutic Virus Development, Boehringer Ingelheim
9:00am - 9:30am
Scale Up and Tech Transfer of an Insect Cell and Baculovirus rAAV Production Process
- Dane Sauffer - Principal Engineer, Eli Lilly and Company
9:30am - 10:00am
Robust and reliable single-use fermenter for highly demanding microbial applications
- Jens Rupprecht - Project Manager, Sartorius Stedim Biotech
8:25am - 8:30am
Chairperson's Opening Remarks
- Tom Ransohoff - Principal, RTI Consulting, LLC
8:30am - 9:00am
Toward automated pooling based upon real-time aggregate detection during cation exchange bind-and-elute chromatography: BioPhorum Phase I results
- Dan Some - Senior Principal Scientist, Wyatt Technology, LLC
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
How new affinity resins can address growing complexities in downstream protein purification
- Tony Thomas - Field Specialist Manager, Purolite, An Ecolab Company
8:25am - 8:30am
Chairperson's Opening Remarks
- Vilas B Shukla, Ph.D., PMP - Senior Principal Engineer, Biologics Project Engineering, NewCo Bio
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
- Brian Recchione - Commercial Supply Chain, ImmunoGen
9:30am - 10:00am
Utilizing Inline Raman Spectroscopy for Monitoring Critical Quality Attributes in Glycosylation Processes
- Lee Asplund - Market and Customer Development Expert, MilliporeSigma
8:55am - 9:00am
Chairperson's Opening Remarks
- Sara Mills - Senior Principal & Head of Cell Therapy, CMC, Dark Horse Consulting
9:00am - 9:30am
Securing Advanced Therapies: Viral Safety Measures, Guidelines, and Personal Perspectives
- Alysia Birkholz - CEO Texcell-North America, Texcell
9:30am - 10:00am
Understanding the Challenges and Guidelines of Cell and Gene Therapy within Viral Clearance
- Crystal Reitman - Supervisor Process Evaluation, Charles River, Charles River
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
- Ken Lee - Director, Bioprocess Technologies and Engineering, BioPharmaceuticals Development, R&D, AstraZeneca
- Lina Chakrabarti - Associate Director, R & D, Astrazeneca
12:00pm - 12:30pm
Scientific Track Presentation by Advanced Instruments
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
Tech transfer Involving the Implementation of an Intensified Fed-Batch Process in Manufacturing
- Nikta D'Ambrosia - Senior Scientist, Boehringer Ingelheim
12:00pm - 12:30pm
Galactose and Mannose Supplementation in Cell Culture - Glycoform Modulation and Other Considerations
- Sudhakar Voruganti - Director, Pfanstiehl Inc
11:00am - 11:30am
Achieving Fully Continuous Downstream
- Magnus Schroeder - Vice President, Just-Evotec Biologics
11:30am - 12:00pm
Intensified Polishing Steps
- Andrew Maloney - Principal Scientist, Amgen
12:00pm - 12:30pm
The "Downstream Problem": Novel uses of Proven Analytical Technology to Address Mounting Challenges in Purification, Quality and Release
- Justin Moretto - Life Science Product Manager, Endress+Hauser
11:30am - 12:00pm
Integrated Development and Manufacturing Strategy for A Flexible Platform and Facility for Multi-Modal Product Development from Gene Therapy, Vaccine to Mab
- David Jen - Principal Consultant, Bioblue CMC Manufacturing Consulting LLC
12:00pm - 12:15pm
Optimized downstream UF/DF bioprocessing of plasmid DNA using ultrafiltration hollow fibers
- Thomas Lazzara, PhD - Director, Research & Development, Meissner
11:00am - 11:30am
High-Throughput Sequencing: A Multi-Attribute Platform for Characterization of rAAV Drug Product
- Huimin Tao - Associate Director, Analytical Development and Operations, Novartis Gene Therapies
11:30am - 12:00pm
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
12:00pm - 12:30pm
Potency Assay: During BLA/MAA Review and After Product Approval
- Yan Zhi - Director, Cell and Gene Therapy Product Owner, Process Engineering, CSL Behring
12:30pm - 1:30pm
Lunch
Showing 3 of 3 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Manufacturing Strategy & Bioprocessing 4.0
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
Simplifying CHO cell line generation with high probability of monoclonality using microfluidics dispensing as an alternative to FACS
- Lina Chakrabarti - Associate Director, R & D, Astrazeneca
1:30pm - 2:00pm
Guiding process optimization with interpretable models and actionable omics
- Nathan Lewis, PhD - Professor, University of California, San Diego
2:00pm - 2:30pm
Feedback-Responsive Cell Factories for Biomanufacturing
- Daniela Barrios - Senior Researcher, Rice University
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 - Fr. Professor for Biochemical Engineering Senior Scientific Advisor, Körber Pharma Austria GmbH
2:30pm - 2:35pm
End of Event
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