September 15 -18, 2025
Hynes Convention CenterBoston, USA
Key Sessions
Inferring secretory and metabolic pathway activity from omic data with secCellFie
Bhanu Chandra Mulukutla
Metabolic Engineering of CHO Cells Towards Cysteine Prototrophy and Systems Analysis of The Ensuing Phenotype
Pfizer
Fire Side Chat: Lessons Learnt of the Path to Commercialization
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
9:00am - 10:30am90 mins
CGT Workshop 1
Potency Masterclass
9:00am - 10:30am90 mins
CGT Workshop 2
Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Tracy Payne - SVP Business Development, Principal Consultant Business Strategy & Operations, Windshire Group, LLC. Labshire, LLC
9:10am - 9:50am40 mins
Keynote Plenary
BPI Keynote 1
9:50am - 10:30am40 mins
Keynote Plenary
BPI Keynote 2
10:30am - 11:10am40 mins
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
11:10am - 12:30pm80 mins
CGT Workshop 1
Potency Masterclass
11:10am - 12:30pm80 mins
CGT Workshop 2
Mastering CDMO Partnerships & External Tech Transfers for Cell & Gene Therapies
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
- Tracy Payne - SVP Business Development, Principal Consultant Business Strategy & Operations, Windshire Group, LLC. Labshire, LLC
11:10am - 12:30pm80 mins
CGT Invite Forums
C-Level Forum
11:10am - 12:30pm80 mins
INVITE ONLY FORUMS
CGT Supply Chain Forum
11:15am - 11:45am30 mins
Cell Line Development & Engineering
Metabolic Engineering of CHO Cells Towards Cysteine Prototrophy and Systems Analysis of The Ensuing Phenotype
- Bhanu Chandra Mulukutla - Group Leader, 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
Scaling Tangential Flow Filtration for Continuous Manufacturing via High Flux, High-Capacity Filtration and Operational Method Optimization
- Ana Di Lillo - Scientist, AstraZeneca
11:15am - 11:45am30 mins
Manufacturing Strategy & Digitalization
The Future of Biologics Manufacturing: Automation, Digitalization, and Innovation
11:15am - 11:45am30 mins
Analytical, Quality and Characterization
Navigating the Regulatory Landscape for Novel Modalities – What We Know (and Don't Know)
11:45am - 12:15pm30 mins
Cell Line Development & Engineering
RNASeq highlights ATF6 pathway regulators for CHO cell engineering with different impacts of ATF6・ｽ・ｽ and WFS1 knockdown on fed-batch production of IgG1
- Mark Blenner - Associate Professor, University of Delaware
11:45am - 12:15pm30 mins
Cell Culture & Upstream Processing
Cry Me A River of Continuous Media: Manufacturing for Commercial Bioreactors
- Yuxin Liu - Scientist, Cell Culture Platform, Sanofi
11:45am - 12:15pm30 mins
Downstream Processing
Continuous Viral Filtration – Ensuring Efficacy & Safety
11:45am - 12:15pm30 mins
Manufacturing Strategy & Digitalization
Mastering Digitalization in Biomanufacturing: Bridging the Skills Gap and Leveraging Innovation Data
11:45am - 12:15pm30 mins
Analytical, Quality and Characterization
Tailoring Analytical Assays for Next-Generation Modalities: From ADCs to Gene Therapies
12:15pm - 12:45pm30 mins
Cell Line Development & Engineering
Sponsored Presentation: Enhancing Cell Line Stability and Productivity: Novel Approaches in Cell Line Engineering
12:15pm - 12:45pm30 mins
Cell Culture & Upstream Processing
Sponsored Presentation: Streamlining Media Optimization With AI-Driven Models
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
Sponsored Presentation: AI in Biomanufacturing: Beyond the Hype – Practical Applications and Limitations
12:15pm - 12:45pm30 mins
Analytical, Quality and Characterization
Sponsored Presentation: The Future of Non-AAV Gene Therapy – Analytical Innovations and Emerging Strategies
12:45pm - 12:50pm5 mins
Break
Transition To Lunch Presentations
12:50pm - 1:35pm45 mins
Scientific Lunch Presentation 1
Lunch Slot 1
12:50pm - 1:35pm45 mins
Scientific Lunch Presentation 2
Lunch Slot 2
12:50pm - 1:35pm45 mins
Scientific Lunch Presentation 3
Lunch Slot 3
12:50pm - 1:35pm45 mins
Scientific Lunch Presentation 4
Lunch Slot 4
12:50pm - 1:35pm45 mins
Scientific Lunch Presentation 5
Lunch Slot 5
12:50pm - 1:35pm45 mins
Scientific Lunch Presentation 6
Lunch Slot 6
12:50pm - 1:35pm45 mins
Scientific Lunch Presentation 7
Lunch Slot 7
12:50pm - 1:35pm45 mins
Scientific Lunch Presentation 8
Lunch Slot 8
1:35pm - 2:00pm25 mins
Lunch Networking
2:00pm - 2:30pm30 mins
Cell Line Development & Engineering
Inferring secretory and metabolic pathway activity from omic data with secCellFie
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
Developing Robust Downstream Processes for Complex Biologics
2:00pm - 2:30pm30 mins
Manufacturing Strategy and Digitalization
Unlocking the Potential of In-Process Analytical Testing Through Automation and Digital Transformation for Biologics
2:00pm - 2:30pm30 mins
Analytical, Quality and Characterization
Innovative Approaches to Potency & Stability: Overcoming Analytical Drug-Delivery Challenges
- Arvind Srivastava, Ph.D. - Senior Vice President, ThirdArcBio
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
2:30pm - 3:00pm30 mins
Cell Line Development & Engineering
A Brand New Antibody Expression Vector
2:30pm - 3:00pm30 mins
Cell Culture & Upstream Processing
Identifying Active Components in Hydrolysates For Consistency
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 and Digitalization
Unveiling the bioprocess revolution – navigating the path to autonomous control
2:30pm - 3:00pm30 mins
Analytical, Quality and Characterization
Emerging Technologies & Bioassay Innovations: Bridging the Gap Between Development and Compliance
- Anand Srinivasan - Vice President of Technology and Innovations, and Head of the Center for Innovations and Biodesign, BioBridge Global
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
Cell Culture & Upstream Processing
Sponsored Presentation: Enhancing Media Development Through Raw Material Quality
3:00pm - 3:30pm30 mins
Downstream Processing
Sponsored Presentation: Targeting High-Risk HCPs: Strategies for Removing Lipases, Chromatin, and Other Problematic Species
3:00pm - 3:30pm30 mins
Manufacturing Strategy and 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
Afternoon Break and Grand Opening of the Exhibit Hall?
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 - 5:30pm60 mins
Cell Culture & Upstream Processing
Sustainability and Supply Chain Resilience in Upstream Bioprocessing
4:30pm - 5:30pm60 mins
Downstream Processing
Roundtable Sessions
4:30pm - 5:00pm30 mins
Manufacturing Strategy & Digitalization
Integrated, Product-Agnostic Biomanufacturing: A Strategy for Agile and Cost-Effective Bioproduction
4:30pm - 5:30pm60 mins
Analytical, Quality and Characterization
Advancing Bioassay Consistency & Real-Time Release: Overcoming Variability and Accelerating Product Approval
4:30pm - 5:10pm40 mins
Cell and Gene Therapy
Fire Side Chat: Lessons Learnt of the Path to Commercialization
5:00pm - 5:30pm30 mins
Cell Line Development & Engineering
Fireside Chat: Realizing the Promise of Synthetic Biology
5:00pm - 5:30pm30 mins
Manufacturing Strategy & Digitalization
Round Table
5:10pm - 5:30pm20 mins
Cell and Gene Therapy
Commercialization Trailblazers: Valuable Lessons Learnt on the Path to Commercialization
5:30pm - 7:00pm90 mins
Networking Drinks
7:00pm - 7:05pm5 mins
Close of Day One
* 活動內容有可能不事先告知作更動及調整。
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