September 15 -18, 2025
Hynes Convention CenterBoston, USA
Key Sessions
Susan Sharfstein, PhD
KEYNOTE: Clonal variation and modulation of glycosylation in development of a biosimilar
University at Albany
Thomas Seewoester
PLENARY KEYNOTE: Readiness of Biomanufacturing for the Digital Highway
Amgen
Tracy Ryan
PLENARY KEYNOTE: From Immune Anarchy to Precision Healing: Sophie’s Journey and the Rise of NKore
NKore BioTherapeutics
Kartik Subramanian, Ph.D.
PLENARY KEYNOTE: The Future of Biologics Manufacturing: Automation, Digitalization, and Innovation
AbbVie
Wolfram Carius, PhD
Panel Discussion: Big Pharma’s CGT Playbook - Top Investment Priorities and Emerging Opportunities
Bayer Pharmaceuticals
Tuesday 16th September - Main Conference Day One - ET (Eastern Time, GMT-05:00)
Tuesday 16th September - Main Conference Day One - ET (Eastern Time, GMT-05:00)
8:00am - 9:00am60 mins
Registration Break
Registration and Morning Coffee
9:00am - 9:10am10 mins
Keynote Plenary
Welcome To BWB/ Chairperson’s Opening Remarks
9:10am - 9:50am40 mins
Keynote Plenary
PLENARY KEYNOTE: Readiness of Biomanufacturing for the Digital Highway
- Thomas Seewoester - Vice President, Site Operations, Amgen
9:50am - 10:30am40 mins
Keynote Plenary
PLENARY KEYNOTE: From Immune Anarchy to Precision Healing: Sophie’s Journey and the Rise of NKore
- Tracy Ryan - Co-Founder & Chief Communications Officer, NKore BioTherapeutics
- Sophie Ryan - Cancer Survivor & Global Advocate, NKore BioTherapeutics
10:30am - 11:10am40 mins
Break
Morning Break
11:10am - 11:15am5 mins
Cell Line Development & Engineering
Chairperson Remarks: Cell Line Development & Engineering
11:10am - 11:15am5 mins
Cell Culture & Upstream Processing
Chairperson Remarks: Cell Culture & Upstream Processing
11:10am - 11:15am5 mins
Downstream Processing
Chairperson Remarks: Downstream Processing
11:10am - 11:15am5 mins
Manufacturing Strategy & Digitalization
Chairperson Remarks: Manufacturing Strategy & Digitalization
11:10am - 11:15am5 mins
Analytical, Quality and Characterization
Chairperson Remarks: Analytical, Quality and Characterization
11:15am - 11:45am30 mins
Cell Line Development & Engineering
KEYNOTE: Next-Gen CHO “Super” Host with Amino Acid Prototrophy and Metabolic Byproduct-Free Phenotype for Superior Bioprocessing
- Bhanu Chandra Mulukutla - Research Fellow, BioTherapeutics Pharmaceutical Sciences, Pfizer
11:15am - 11:45am30 mins
Cell Culture & Upstream Processing
Utilizing Amino Acid Uptake and Simulation Tools for CHO Process Optimization
- Shruti Santhosh - Engineer II, Biogen
11:15am - 11:45am30 mins
Downstream Processing
Evaluation of Alternative Filtration Technology for Improved Product Quality and Efficiency: Harvest RC, RCC and Polisher ST Compared to a Platform
- Marc Schrader - Senior Scientist, Abbvie
11:15am - 11:45am30 mins
Manufacturing Strategy & Digitalization
PLENARY KEYNOTE: The Future of Biologics Manufacturing: Automation, Digitalization, and Innovation
- Kartik Subramanian, Ph.D. - Vice President, Biologics Product Development, Science and Technology, AbbVie
11:15am - 11:45am30 mins
Analytical, Quality and Characterization
PLENARY KEYNOTE: The Future of Biologics Manufacturing: Automation, Digitalization, and Innovation
- Kartik Subramanian, Ph.D. - Vice President, Biologics Product Development, Science and Technology, AbbVie
11:45am - 12:15pm30 mins
Cell Line Development & Engineering
Long-lived epigenetically heritable gene expression fluctuations drive biomarkers for industrial cell line development
- Mark Blenner - Associate Professor, University of Delaware
11:45am - 12:15pm30 mins
Cell Culture & Upstream Processing
Cell culture media development for intensified bioprocessing to improve productivity
- Yuxin Liu - Scientist, Cell Culture Platform, Sanofi
11:45am - 12:15pm30 mins
Downstream Processing
Fireside Chat: Implementing Automation and Root Cause Analysis to save time in Downstream Processing
- A Representative - from, Regeneron
11:45am - 12:15pm30 mins
Manufacturing Strategy & Digitalization
Accelerating Early-Stage Biopharmaceutical Process Development through Integrated Robotic Automation
- Yuxiang (Henry) Zhao - Senior Scientist, Bristol-Myers Squibb
11:45am - 12:15pm30 mins
Analytical, Quality and Characterization
Online HIC-MS for deeper ADC characterization
- Zhengqi Zhang - Senior Scientist, Merck
12:15pm - 12:45pm30 mins
Cell Line Development & Engineering
Improving Bioprocessing Outcomes with the Next Generation of CHOZN® Host Cell Lines
- Michael Johns - Senior Scientist, MilliporeSigma
12:15pm - 12:45pm30 mins
Cell Culture & Upstream Processing
Oceo Rover: The First On-Demand, Automated Solution for Powdered Media and Buffer Hydration
- Guy Matthews - Director - Market Development Single Use Technology, Fuji Film Irvine Scientific
12:15pm - 12:45pm30 mins
Downstream Processing
Sponsored Presentation: Process Intensification in Downstream Processing: Achieving Higher Yields and Faster Turnaround Times
12:15pm - 12:45pm30 mins
Manufacturing Strategy & Digitalization
AI in Biomanufacturing: Beyond the Hype - Practical Applications and Limitations
12:15pm - 12:45pm30 mins
Analytical, Quality and Characterization
The Rise of Modular Reagent Manufacturing -- Scalable Solutions to Accelerate Novel Gene Therapy Development
12:45pm - 1:00pm15 mins
Break
Transition To Lunch Presentations
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 1
'Lunch n Learn' Presentation by Sartorius
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 2
'Lunch n Learn' Presentation by Cytiva
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 3
'Lunch n Learn' Presentation by Catalent
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 4
'Lunch n Learn' Presentation by Benchling
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 5
'Lunch n Learn' Presentation by Advanced Instruments
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 6
'Lunch n Learn' Presentation by Sartorius
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 7
Lunch Slot 7
1:00pm - 1:45pm45 mins
Scientific Lunch Presentation 8
Lunch Slot 8
1:45pm - 2:00pm15 mins
Break
Lunch Networking
2:00pm - 2:30pm30 mins
Cell Line Development & Engineering
KEYNOTE: Clonal variation and modulation of glycosylation in development of a biosimilar
- Susan Sharfstein, PhD - Professor of Nanoscale Science and Engineering, University at Albany
2:00pm - 2:30pm30 mins
Cell Culture & Upstream Processing
Development and Transition Strategy for Biologics Platform Media-Feed Solutions
- Lynn Mao - Senior Scientist, AstraZeneca
2:00pm - 2:30pm30 mins
Downstream Processing
KEYNOTE: Developing Robust Downstream Processes for Complex Biologics
- Olga Paley, Ph.D. - Director and Head of US Late Stage Downstream Process Development, Takeda
2:00pm - 2:30pm30 mins
Manufacturing Strategy & Digitalization
Unlocking the Potential of In-Process Analytical Testing Through Automation and Digital Transformation for Biologics
- Dhanuka Wasalathanthri, PhD - Associate Director, Bristol Myers Squibb
2:00pm - 3:00pm60 mins
Analytical, Quality and Characterization
PANEL DISCUSSION: Analytical Strategies for Next-Gen Biologics - Aligning Science and Regulation
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
2:00pm - 2:05pm5 mins
Cell and Gene Therapy
Welcome to Cell and Gene Therapy International and Chairperson’s Opening Remarks
2:05pm - 2:50pm45 mins
Cell and Gene Therapy
Panel Discussion: Big Pharma’s CGT Playbook - Top Investment Priorities and Emerging Opportunities
- Wolfram Carius, PhD - Executive Vice President, Pharmaceuticals, Cell and Gene Therapy, Bayer Pharmaceuticals
- Erin Kimbrel - President & Head, Astellas Institute for Regenerative Medicine
- Stephen Kennedy - Head of Technical Operations, CRISPR Therapeutics
- Ruth Salmon - VP, BMS Cell Therapy Research, Bristol Myers Squibb
2:30pm - 3:00pm30 mins
Cell Line Development & Engineering
Novel Technologies to Enhance Antibody Expression, Accelerate Cell Line Development, and Improve Stability in CHO Cells
- Song Zhiwei - Senior Principal Scientist, Nexa Biologics
2:30pm - 3:00pm30 mins
Cell Culture & Upstream Processing
Glycosylation profiles monitored in bioproducts from bioprocessing
- Michael Butler - Principal Investigator, Cell Technology, NIBRT
2:30pm - 3:00pm30 mins
Downstream Processing
Uncharted ADC purification: characterization and raw material validation of a carbon filter for the removal of impurities in ADC manufacturing
- Christine Pham - Principal Scientist, Purification Process Development, Gilead
2:30pm - 3:00pm30 mins
Manufacturing Strategy & Digitalization
Unveiling the bioprocess revolution - navigating the path to autonomous control
- A Representative from Biophorum - -, BioPhorum
2:50pm - 3:30pm40 mins
Cell and Gene Therapy
Investments in Cell and Gene Therapies and Enabling Technologies
- Bryan Poltilove - Strategic Advisor and Independent Board Director, Independent
- Daniel Friedman - Principal, BroadOak Capital
- Aaron Fisher - Director, Life Sciences Investments, ARCHIMED
3:00pm - 3:30pm30 mins
Cell Line Development & Engineering
Sponsored Presentation: The Evolution of Transposons: Stability, Titre, and Beyond
3:00pm - 3:30pm30 mins
Downstream Processing
Challenges in removing process related impurities for complex fusion proteins
3:00pm - 3:30pm30 mins
Manufacturing Strategy & Digitalization
Sponsored Presentation: Taming the Beast: Innovative Manufacturing Strategies for Complex Biologics
3:00pm - 3:30pm30 mins
Analytical, Quality and Characterization
Sponsored Presentation: Ensuring Regulatory Compliance in Potency & Release Testing: Best Practices for Biologics and Advanced Therapies
3:30pm - 4:30pm60 mins
Break
Afternoon Break and Grand Opening of the Exhibit Hall
3:30pm - 4:00pm30 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase / Theater
4:30pm - 5:00pm30 mins
Cell Line Development & Engineering
A high-fidelity, dual site-specific integration system in CHO cells by a Bxb1 recombinase
- Yifeng Xu - Principal Scientist, Pfizer
4:30pm - 5:00pm30 mins
Cell Culture & Upstream Processing
Scaling Tangential Flow Filtration for Continuous Manufacturing via High Flux, High-Capacity Filtration and Operational Method Optimization
- Ana Di Lillo - Scientist, AstraZeneca
4:30pm - 5:30pm60 mins
Downstream Processing
Round Table Sessions
- Stefano Menegatti - Associate Professor, North Carolina State University
4:30pm - 5:00pm30 mins
Manufacturing Strategy & Digitalization
Increasing bioprocess robustness despite Starting-Material Variability: A toolbox of digital applications
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
4:30pm - 5:30pm60 mins
Analytical, Quality and Characterization
Round Table Sessions
- Linda Yi - Associate Director, Analytical Development, Biogen
4:30pm - 5:10pm40 mins
Cell and Gene Therapy
Fire Side Chat: Lessons Learnt of the Path to Commercialization
4:30pm - 4:40pm10 mins
Innovation and Community Stage (Exhibit Hall)
SUS
4:40pm - 5:00pm20 mins
Innovation and Community Stage (Exhibit Hall)
Catapult Cell & Gene Therapy
5:00pm - 5:30pm30 mins
Cell Line Development & Engineering
Fireside Chat: Realizing the Promise of Synthetic Biology
5:00pm - 5:30pm30 mins
Cell Culture & Upstream Processing
Copper loss in CHO cell culture media and mitigation strategies
- Emily Ritterhaus - Senior Scientist, Process Development Upstream Biologics Development, Bristol Myers Squibb
5:00pm - 5:30pm30 mins
Manufacturing Strategy & Digitalization
PAT, process control and smart manufacturing
- Victoria Kennedy - Scientist, Sanofi
5:10pm - 5:30pm20 mins
Cell and Gene Therapy
Building Customer Confidence and Reducing Risk with Early Access to Development Teams
- Sara Miller - Director, Advanced Therapies Commercial Technical Lead, FUJIFILM Biotechnologies
5:20pm - 5:30pm10 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
5:30pm - 7:00pm90 mins
Break
Networking Reception in the Exhibit Hall
5:30pm - 6:00pm30 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
6:00pm - 6:30pm30 mins
Innovation and Community Stage (Exhibit Hall)
OUTBio Fireside Chat/Panel - Fostering Inclusion in Biopharma: Beyond Compliance to Meaningful Change
6:30pm - 7:00pm30 mins
Innovation and Community Stage (Exhibit Hall)
Tech Showcase
7:00pm - 7:05pm5 mins
Break
Close of Day One
* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.
Filter
Streams