March 18-21, 2025
San Diego Convention CenterSan Diego, CA, USAKey Sessions
Saurabh Sen
Green Lab Initiatives and Sustainable Practices – How Every Stage can Assist with Carbon Emissions, Water Usage and Waste?
Sanofi
Nathan Lewis, PhD
Advances in Machine Learning for Cell Line Development To Predict Better Clones, Reduce Timelines & Experiments
University of California, San Diego
Amy Shaw
Addressing the Challenges in Allogenic Cell Therapy Manufacturing
Takeda, USA
Jose Vidal
FIRESIDE CHAT: The Need for Continuous Requalification & Support of Cell & Gene Therapy Distribution
CytoImmune, USA
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Thursday 20th March - Main Conference Day Two - PT (Pacific Time, GMT-08:00)
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Thursday 20th March - Main Conference Day Two - PT (Pacific Time, GMT-08:00)
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8:25am - 8:55am
Registration and Morning Coffee
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Manufacturing Strategy & Digital Transformation
Recovery & Purification
Cell and Gene Therapy Manufacturing
8:55am - 9:00am
Chairperson's Remarks: Cell Line Development & Engineering
9:00am - 9:30am
Advances in Machine Learning for Cell Line Development To Predict Better Clones, Reduce Timelines & Experiments
- Nathan Lewis, PhD - Professor, University of California, San Diego
9:30am - 10:00am
How Reliable are Chinese Hamster Ovary (CHO) Cell Genome-scale Metabolic Models?
- James Morrissey - Postdoctoral Fellow, Vaccine Production Program, NIAID Vaccine Research Centre
8:55am - 9:00am
Chairperson's Remarks: Cell Culture & Upstream Processing
9:00am - 9:30am
Development of Two Alternative CHO Culture Harvest Processes using Acid Precipitation and Cationic Flocculation
- Victoria Drake Carnein - Upstream Process Development Scientist I, Alexion AstraZeneca Rare Disease
9:30am - 10:00am
Reduce Workload via AI, Machine Learning, and Modeling in Bioprocessing
- A Representative - From, Takeda
8:55am - 9:00am
Chairperson's Remarks: Manufacturing Strategy & Bioprocessing 4.0
- Mia Wang - Senior Director, CMC Team Leader, Gilead, USA
9:00am - 9:30am
A risk-based approach to Artificial Intelligence and Machine Learning
- Scott Steele - Senior Advisor, CBER, FDA, USA
9:30am - 10:00am
Optimizing Process Development and Clinical Production Efficiency with Continuous Improvement Projects
- Chiali Liu - Senior Director, Drug Substance Development, Teva Pharmaceuticals
10:00am - 10:30am
Scientific Presentation by Thermo Fisher
8:55am - 9:00am
Chairperson's Remarks: Recovery & Purification
9:00am - 9:30am
Improved Affinity Tag Self-Removal via Targeted Protein Engineering
- Sabat Gonzalez-Serrano - Graduate Research Associate, The Ohio State University
9:30am - 10:00am
Development and evolution of downstream purification platform for inhalable biologics
- Haibin Luo, PhD - Director of Downstream Process Development, BioPharmaceutical Development, AstraZeneca
8:55am - 9:00am
Chairperson's Remarks: Cell and Gene Therapy Manufacturing
9:00am - 10:00am
FIRESIDE CHAT: The Need for Continuous Requalification & Support of Cell & Gene Therapy Distribution
- Looking at recent FDA disclosures and contamination risks;
- What is the industry doing to work on the need for continuous requalification;
- Looking at performance of the equipment and processes and well as transportation and distribution.
- Jose Vidal - Chief Operating Officer, CytoImmune, USA
10:00am - 10:30am
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
10:30am - 11:40am
Morning Networking Break
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Manufacturing Strategy & Digital Transformation
Recovery & Purification
Cell and Gene Therapy Manufacturing
11:40am - 12:10pm
Optimizing Cell Line Development of Bispecific Antibodies by Customized Plasmid Configuration Modulation
- Zheng Zhang - Director, Cell Line Development, BeiGene
12:10pm - 12:40pm
A Comparative Study of Random Integration vs. Transposon-Based System for Bispecific Antibody
- Yashas Rajendra Ph.D. - Director & Principal Scientist, Denali Therapeutics
11:40am - 12:10pm
Design Experiments to Obtain Desirable Product Quality Attributes for Protein Biologics
- Jared Dopp - Scientist, Upstream Process Development, Bristol-Myers Squibb
12:10pm - 12:40pm
Co-Culturing Cell Lines for Efficient Manufacture of Multispecifics
- Dawn Eriksen-Stapleton, PhD - Principal Scientist, Pfizer
12:40pm - 1:10pm
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
11:40am - 12:10pm
Next-Gen Bioprocessing: Leveraging Industry 4.0 for Smart Biomanufacturing Facilities
- Bala Reddy - Fonder & Managing Director, Provis Biolabs Pvt Ltd
12:10pm - 12:40pm
BioPharm Manufacturing Optimization with a Factory Digital Twin
- Joseph Pekny - Professor, Chemical Engineering, Purdue University
12:40pm - 1:10pm
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
11:40am - 12:40pm
PANEL DISCUSSION: Building Strategic Partnerships for Downstream Success
- CDMO Landscape:
- Benefits of partnering for facility design, equipment selection, etc.
- Key Selection Criteria:
- Identifying and prioritizing the important factors to consider when selecting a partner within downstream.
- Approaching Tech Transfer and Best Practices;
- Real-world experiences of successful facility fit-outs and collaborations that have led to improved efficiency, reduced costs, and enhanced product quality.
- Shalima Sreenath - Head of Downstream Process Development, Cellibre
12:40pm - 1:10pm
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
11:40am - 12:10pm
KEYNOTE PRESENTATION: Poseida Therapeutics
- Loren Wagner - Chief Operations Officer, Poseida Therapeutics, USA
12:10pm - 12:40pm
Tuning CAR-T Cell Phenotype Through Enhanced Bioprocess Control in Stirred -Tank Bioreactors
- Manuel Carrondo - Vice-President, Instituto de Biologia Experimental e Tecnológica
1:10pm - 2:40pm
Lunch
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Manufacturing Strategy & Digital Transformation
Recovery & Purification
Cell and Gene Therapy Manufacturing
2:40pm - 2:45pm
Chairperson's Remarks: Cell Line Development & Engineering
2:45pm - 3:15pm
Green Lab Initiatives and Sustainable Practices – How Every Stage can Assist with Carbon Emissions, Water Usage and Waste?
- Saurabh Sen - Associate Director, Cell Line Development, Genomic Medicine Unit CMC, Sanofi
3:15pm - 3:45pm
CLE Toolbox: Optimizing Parental Cell Lines for Better Expression
- Sara Maimouni, PhD - Scientist, Cell Line Development, Sanofi
2:40pm - 2:45pm
Chairperson's Remarks: Cell Culture & Upstream Processing
2:45pm - 3:15pm
Optimizing Metabolic Flux in CHO Cells: A Hybrid Approach for Improved Cell Culture Productivity
- Eliot Boulanger - Co-Founder and CEO, Levacells
3:15pm - 3:45pm
ADCs: Translating from Bench to Production Scale
- Scaling up the production process while maintaining product quality and yield requires careful optimization and validation;
- Ensuring consistent product quality during scale-up is critical. This includes maintaining the same glycosylation patterns, folding, and other quality attributes at larger scales;
- Adhering to Guidelines: Meeting the stringent regulatory requirements for the production of ADCs.
2:40pm - 2:45pm
Chairperson's Remarks: Manufacturing Strategy & Bioprocessing 4.0
- Mia Wang - Senior Director, CMC Team Leader, Gilead, USA
2:45pm - 3:15pm
Network-Based Scale-Up Data Collection and Analysis for AI Controlled Bioreactor Operations
- Deepti Tanjore - Chief Product Officer, enScale Bio
3:15pm - 3:45pm
Maximizing the Impact of Digital Twins in Bioprocess Development and Manufacturing
- Maximilian Krippl - Head of Consulting, Novasign GmbH
2:40pm - 2:45pm
Chairperson's Remarks: Recovery & Purification
2:45pm - 3:15pm
Challenges and solutions to manufacturing of low viscosity, ultra-high concentration IgG1 drug products: From late downstream process to final fill finish processing.
- Vaibhav Deokar - Principal Scientist, Lupin Limited (Biotech Division)
3:15pm - 3:45pm
Evaluating Viral Clearance Efficiency in AAV Downstream Processing with Aged Chromatography Resin
- Wenjun Di - Senior Scientist, Ultragenyx Pharmaceutical Inc.
2:40pm - 2:45pm
Chairperson's Remarks: Cell and Gene Therapy Manufacturing
2:45pm - 3:15pm
US FDA Regulatory Considerations for Cell and Gene Therapies
- Stéphanie Val - Gene Therapy CMC Reviewer, Office of Gene Therapy, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, USA
3:15pm - 3:45pm
Addressing the Challenges in Allogenic Cell Therapy Manufacturing
- Amy Shaw - Head of Process and Product Development, Cell Therapy Sciences, Takeda, USA
3:45pm - 4:45pm
Afternoon Break
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Manufacturing Strategy & Digital Transformation
Recovery & Purification
Cell and Gene Therapy Manufacturing
4:45pm - 5:15pm
NISTCHO: An open access, living reference material for biomanufacturing
- Zvi Kelman - Director, Biomolecular Labeling Laboratory, NIST
5:15pm - 5:45pm
Chromatin accessibility plays an important epigenetic role on antibody expression from CMV promoter and DNA elements surrounding the CHO TI host landing-pad
- Shahram Misaghi, PhD - Staff Scientist, Genentech, Inc
4:45pm - 5:15pm
Comprehensive Modeling of Cell Culture Profile Using Raman Spectroscopy and Machine Learning
- Hiroki Tanemura - Upstream process development researcher, Daiichi Sankyo Co
5:15pm - 5:45pm
High-Throughput Workflows and Automation For High Productivity, Reduced CoG and Time Saving
- A Representative - |, Novartis
4:45pm - 5:45pm
PANEL DISCUSSION: Technology as a Catalyst to Revolutionize the Future of Biomanufacturing
- Implementing next-generation technologies, including AI/ML-powered tools, for optimized efficiency;
- How can you seamlessly incorporate technologies?
- Where do we think manufacturing technology is heading in the next 5-10 years?
- Deepti Tanjore - Chief Product Officer, enScale Bio
- Maximilian Krippl - Head of Consulting, Novasign GmbH
- Ramila Peiris - Global Head of Process Data Management, ML and AI Platform, MSAT, Sanofi
- Semsi Ensari - Sr Director, Process Development, Kite Pharma
4:45pm - 5:15pm
Mechanisms and modeling of depth filtration in biopharma
- Abraham Lenhoff - Allan P. Colburn Professor, University of Delaware
5:15pm - 5:45pm
PAT-Integrated Downstream Processing of Novel Modalities
- Stefano Menegatti - Associate Professor, North Carolina State University
4:45pm - 5:45pm
Innovation Showcase
Talk 1: Driving digital innovation for supply chain orchestration in cell and gene therapy
Christian Fuchs, Head of Orchestration and Exceptions Management for Cell & Gene Therapy (CGT) at Roche/Genentech, USA
Talk 2: Therapeutic epigenome editing: safety and quality considerations of a new class of gene-targeted medicines
Houria Bachtarzi, Principal Consultant, Founding Director, BIOCELLGENE Consulting Ltd, UK
Talk 3: Successfully Implementing Emerging Technologies
Manuel Orsorio, Senior Scientist, Emerging Technologies, CBER, FDA, USA
5:45pm - 7:15pm
Outdoor Evening Drinks Reception/Party
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