Key Sessions

Lina Chakrabarti

Overview of Available Automation Tools for Cell Line Development

Astrazeneca

Jongyoon Han, Ph.D.

Monitoring cellular senescence in intensified CHO and HEK293 cultures, and its implications to productivity

Massachusetts Institute of Technology

Jianlin (Jim) Xu

KEYNOTE: N-1 perfusion business case study

Sanofi

Brenda Carillo-Conde

Development and implementation of PAT to support scale-up and process characterization of glycoconjugate vaccines

Pfizer

Thursday 18th September - Main Conference Day ThreeThursday, 18 September 2025 - ET (Eastern Time, GMT-05:00)

8:30am - 8:55am25 mins

Registration Break

Registration and Morning Coffee

8:55am - 9:00am5 mins

Cell Line Development & Engineering

Chairperson Remarks: Cell Line Development & Engineering

8:55am - 9:00am5 mins

Cell Culture & Upstream Processing

Chairperson Remarks: Cell Culture & Upstream Processing

8:55am - 9:00am5 mins

Downstream Processing

Chairperson Remarks: Downstream Processing

8:55am - 9:00am5 mins

Manufacturing Strategy & Digitalization

Chairperson Remarks: Manufacturing Strategy & Digitalization

8:55am - 9:00am5 mins

Analytical, Quality and Characterization

Chairperson Remarks

8:55am - 9:00am5 mins

Development of Emerging Cell & Gene Therapies

Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies

8:55am - 9:00am5 mins

Cell Therapy Manufacturing & Analytics

Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics

8:55am - 9:00am5 mins

Gene Therapy Manufacturing & Analytics

Chairperson’s Opening Remarks: Gene Therapy Manufacturing & Analytics

Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi

9:00am - 9:30am30 mins

Cell Line Development & Engineering

Fireside Chat: The CLD Toolbox: Your Essentials To a High Titre, High Quality and Rapid Cell Line

9:00am - 9:30am30 mins

Cell Culture & Upstream Processing

KEYNOTE: N-1 perfusion business case study

Jianlin (Jim) Xu - Global Head of Cell Culture Platform, Sanofi

9:00am - 9:30am30 mins

Downstream Processing

Development and implementation of PAT to support scale-up and process characterization of glycoconjugate vaccines

Brenda Carillo-Conde - Group Leader, Pfizer

9:00am - 9:30am30 mins

Manufacturing Strategy & Digitalization

Noval Technology Applied to Biologics Manufacturing

Wei Huang - President, Henlius Biopharmaceutical Ltd, China

9:00am - 9:30am30 mins

Analytical, Quality and Characterization

AI & ML in Analytics - What’s Real and What’s Hype?

9:00am - 9:30am30 mins

Development of Emerging Cell & Gene Therapies

Starting with the End in Mind: Designing Smart for Successful Cell & Gene Therapy Development

Jeff Masten - Senior Vice President CMC, Secretome Therapeutics

9:00am - 9:30am30 mins

Cell Therapy Manufacturing & Analytics

Expanding Access to CAR-T cell Therapies by Manufacturing CRISPR Engineered Allogeneic Cell Therapies

Justin Skoble - Vice President of Technical Development, Caribou Biosciences, Inc.

9:00am - 9:30am30 mins

Gene Therapy Manufacturing & Analytics

Fast Forward - CMC Planning and Execution to Support an Accelerated Approval Pathway

Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.

9:30am - 10:00am30 mins

Cell Line Development & Engineering

Overview of Available Automation Tools for Cell Line Development

Lina Chakrabarti - Associate Director, R & D, Astrazeneca

9:30am - 10:00am30 mins

Cell Culture & Upstream Processing

Streamlining CHO Expression Across Research, PD and Manufacturing for Speed to the Clinic

Keshab Rijal - Principal Scientist, Amgen

9:30am - 10:00am30 mins

Downstream Processing

AI, Automation & Machine Learning - The Future of Bioprocessing

Abraham Lenhoff - Allan P. Colburn Professor, University of Delaware

9:30am - 10:00am30 mins

Manufacturing Strategy & Digitalization

Transfer of PAT methods from the process development space to the GMP space

Yuxin He - Sr Engineer II, Moderna

9:30am - 10:00am30 mins

Analytical, Quality and Characterization

Accelerating Digital Transformation in Analytical Workflows: Integrating Real-Time Data Across Platforms

Nick Alden - Associate Director, Analytical Development Automation, Ultragenyx Pharmaceutical

9:30am - 10:00am30 mins

Development of Emerging Cell & Gene Therapies

Development of Next-Gen Cell & Gene Therapies - Gamma-Delta T Cell Engager Technology Case Study

Kate Rochlin - Chief Operating Officer, IN8bio

9:30am - 10:00am30 mins

Cell Therapy Manufacturing & Analytics

Scale Up and Manufacturing Challenges of Next-Generation Allogeneic Cell Therapies

Monica Raimo - Director, Product and Process Development, Glycostem Therapeutics

9:30am - 10:00am30 mins

Gene Therapy Manufacturing & Analytics

BLA Filing and Process Characterization

Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical

10:00am - 10:30am30 mins

Cell Line Development & Engineering

Sponsored Presentation: Breakthrough Automation Technologies for CLD and Revolutionizing Workflows

10:00am - 10:30am30 mins

Cell Culture & Upstream Processing

Sponsored Presentation: Improving Cell Culture Productivity Through Process Intensification Strategies

10:00am - 10:30am30 mins

Downstream Processing

Sponsored Presentation: The Role of Automation in Streamlining Downstream Processing

10:00am - 10:30am30 mins

Manufacturing Strategy & Digitalization

Sponsored Presentation: Managing Comparability and Commercialization

10:00am - 10:30am30 mins

Analytical, Quality and Characterization

Sponsored Presentation: The Regulatory Implications of AI/ML Biologics Analytics

10:00am - 10:30am30 mins

Development of Emerging Cell & Gene Therapies

Next-Gen Innovations: Cutting Edge Technologies Driving the Future of Cell and Gene Therapies

10:00am - 10:30am30 mins

Cell Therapy Manufacturing & Analytics

Scaling Up Allogeneic Cell Therapies: Cutting-Edge Technological Breakthroughs

10:00am - 10:30am30 mins

Gene Therapy Manufacturing & Analytics

Navigating Regulatory Pathways for Gene Therapy Success from R&D to BLA

10:30am - 11:20am50 mins

Break

Morning Break

11:20am - 11:50am30 mins

Cell Line Development & Engineering

Evaluation of a Flow Cytometry toolkit to assess production cell line phenotypes during bioprocess development

Daniel Burke - Senior Scientist, Merck

11:20am - 11:50am30 mins

Cell Culture & Upstream Processing

Process Intensification Strategies for Enhancing CHO-Based Biologic Production

Andrei Arion - Associate Scientist, Cell Line and Upstream Process Development, Alexion, AstraZeneca Rare Disease

11:20am - 11:50am30 mins

Downstream Processing

Automated End-to-end Data Paradigm for Biologics Bioprocess Development

Yi Li - Process Development Scientist, Amgen, Inc.

11:20am - 11:50am30 mins

Manufacturing Strategy & Digitalization

From Development to Submission: Streamlining CMC Processes

11:20am - 11:50am30 mins

Analytical, Quality and Characterization

Automated High-Throughput Assays: Revolutionizing Efficiency and Accelerating Discovery in Biopharma Analytics

11:20am - 11:50am30 mins

Development of Emerging Cell & Gene Therapies

Stromal-Free, GMP-Compatible Bioprocess for Generating Allogeneic CAR-γδ T Cells from Cord Blood CD34+ HSPC

Victor Manuel Diaz Cortes - Research Director, OneChain Immunotherapeutics S.L.

11:20am - 11:50am30 mins

Cell Therapy Manufacturing & Analytics

From Bench to Bedside: Developing a Roadmap for Large Scale Manufacturing of iPSCs

Nicole Santimauro - Senior Engineer, Manufacturing Science and Technology, Century Therapeutics, Inc.

11:20am - 11:50am30 mins

Gene Therapy Manufacturing & Analytics

Advances in Analytical Method Development for the Characterization of AAVs

Wei-Chiang Chen - Associate Director, BioProcess Analytics, Genomic Medicine Unit, Sanofi

11:50am - 12:20pm30 mins

Cell Line Development & Engineering

Development of an on-chip binding assay to select clones expressing high quality bispecific antibodies

Shu Wang - Principal Investigator, Incyte

11:50am - 12:20pm30 mins

Cell Culture & Upstream Processing

Monitoring cellular senescence in intensified CHO and HEK293 cultures, and its implications to productivity

Jongyoon Han, Ph.D. - Professor, PI of the Micro-Nanofluidic BioMEMS group at RLE, Massachusetts Institute of Technology

11:50am - 12:20pm30 mins

Downstream Processing

In Silico Process Development for Less Work, More Accuracy - Merging Digital Twins & Machine Learning

11:50am - 12:20pm30 mins

Manufacturing Strategy & Digitalization

The Future of Manufacturing Operations

A Representative from Biophorum - -, BioPhorum

11:50am - 12:20pm30 mins

Analytical, Quality and Characterization

Automation of Cell-Based Assays: Challenges and Strategic Approaches

Divyanshu Malhotra - Senior Scientist, Genmab

11:50am - 12:05pm15 mins

Development of Emerging Cell & Gene Therapies

INNOVATION HOUR: Development of Next-Gen Cell and Gene Therapies Case Studies

11:50am - 12:20pm30 mins

Cell Therapy Manufacturing & Analytics

Cryopreservation Development in Cell Therapy Manufacturing and Scale Up Challenges

Yuechen Zhu - Staff Development Scientist, Bayer

11:50am - 12:20pm30 mins

Gene Therapy Manufacturing & Analytics

Upstream and Downstream Process Characterization of UX701 AAV Gene Therapy for Wilson Disease

Jun Li - Associate Director - Upstream Process Development: Gene Therapy, Ultragenyx Pharmaceutical

12:05pm - 12:20pm15 mins

Development of Emerging Cell & Gene Therapies

INNOVATION HOUR: Case Study from Satellite Bio

Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio

12:20pm - 12:50pm30 mins

Cell Line Development & Engineering

Sponsored Presentation: Successful Upstream Process Development for Bispecifics and ADCs

12:20pm - 12:50pm30 mins

Cell Culture & Upstream Processing

Perfusion Strategies for Viral Vector Production in HEK293 Cell Culture

12:20pm - 12:50pm30 mins

Downstream Processing

Sponsored Presentation: Process Optimization and Control at Scale

12:20pm - 12:50pm30 mins

Manufacturing Strategy & Digitalization

Sponsored Presentation: Meeting the Growing Demand for Biologics: Innovative Solutions for Capacity Expansion

12:20pm - 12:50pm30 mins

Analytical, Quality and Characterization

Sponsored Presentation: Transforming QC: Automation, High-Throughput Analytics, and Real-Time Release Testing for Next-Gen Biomanufacturing

12:20pm - 12:35pm15 mins

Development of Emerging Cell & Gene Therapies

INNOVATION HOUR: Sponsored Scientific Track Presentation

12:20pm - 12:50pm30 mins

Cell Therapy Manufacturing & Analytics

Next Generation Preservation and Storage Solutions for Cell Therapy Products

12:20pm - 12:50pm30 mins

Gene Therapy Manufacturing & Analytics

Novel Analytical Technologies to Enhance Gene Therapy Product and Process Characterization

12:35pm - 12:50pm15 mins

Development of Emerging Cell & Gene Therapies

INNOVATION HOUR: Sponsored Scientific Track Presentation

12:50pm - 2:00pm70 mins

Break

Lunch Networking

2:00pm - 2:30pm30 mins

Cell Line Development & Engineering

Hunting genomic hotspots in CHO genome for site specific integration

Efecan Aral - Postdoctoral Associate, Cell Science and Technology, Sanofi

2:00pm - 2:30pm30 mins

Cell Culture & Upstream Processing

Aligning with Regulatory Expectations in a Fast-Paced Environment

2:00pm - 2:30pm30 mins

Downstream Processing

Challenges and opportunities presented by high concentration (>200 g/L) ultrafiltration/diafiltration

Emma Cooper - Process Development Engineer, Regeneron

2:00pm - 2:30pm30 mins

Manufacturing Strategy & Digitalization

Streamlining Tech Transfer: Overcoming Data Challenges and Modernizing Processes

2:00pm - 2:30pm30 mins

Analytical, Quality and Characterization

Analytical Innovation Showcase: Preparing for the Next Wave of Biologics Characterizations

2:00pm - 2:30pm30 mins

Development of Emerging Cell & Gene Therapies

Development of Next-Gen Cell and Gene Therapies Case Studies

Reagan Jarvis - Chief Executive Officer and Co-founder, Anocca

2:00pm - 2:30pm30 mins

Cell Therapy Manufacturing & Analytics

Visible Particles Within Cell Therapies- A Holistic and Strategic Approach to Characterize, Identify and De-Risk The Presence Of Visible Particulates In ATMP Drug Product Formulations

Shankar Swaminathan, PhD - Team Lead, Associate Director Drug Product Development, Astellas Institute for Regenerative Medicine

2:00pm - 2:30pm30 mins

Gene Therapy Manufacturing & Analytics

Potency Assays - Ensuring Consistency and Reliability for Gene Therapies - From Development to Standardization

2:30pm - 3:30pm60 mins

Cell Line Development & Engineering

PANEL DISCUSSION: The Growing Complexity of Biotherapeutics

Jacqualyn Schulman, Ph.D. - Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb

2:30pm - 3:30pm60 mins

Cell Culture & Upstream Processing

PANEL DISCUSSION: Accelerating Speed to Market in Upstream Cell Culture and Bioprocessing: Overcoming Challenges and Leveraging Technologies

A Representative from Eli Lilly - Upstream Department, Eli Lilly

2:30pm - 3:00pm30 mins

Downstream Processing

Polysaccharide Drug Substance Production: Optimization and Scale-up of Purification Unit Operations

Sidharth Razdan - Senior Scientist, Pfizer

2:30pm - 3:30pm60 mins

Manufacturing Strategy & Digitalization

PANEL DISCUSSION: Beyond the Contract: Optimizing CDMO Relationships for Accelerated Drug Development

2:30pm - 3:00pm30 mins

Analytical, Quality and Characterization

Fireside Chat: Implementing Next-Generation Analytical Technologies: Overcoming Challenges in Validation, Data Management, and Regulatory Compliance

Seth Levy - Senior Director, Bioprocess Development, Modalis Therapeutics
Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals

2:30pm - 3:00pm30 mins

Development of Emerging Cell & Gene Therapies

Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing

Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics

2:30pm - 3:00pm30 mins

Cell Therapy Manufacturing & Analytics

Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing

Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics

2:30pm - 3:00pm30 mins

Gene Therapy Manufacturing & Analytics

Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing

Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics

3:00pm - 3:30pm30 mins

Downstream Processing

Aggregates PoC: Adaptive automated cation exchange pooling based on real-time process analytical technology (PAT) monitoring for aggregates

Moira Lynch - Director, Innovation, Thermo Fisher Scientific

3:00pm - 3:30pm30 mins

Analytical, Quality and Characterization

Fireside Chat: Selecting and Applying Next-Generation Analytical Technologies: A Modality-Specific Approach

Rosalind Ang - Associate Principal Scientist - Biologics & Analytical Research & Development, Merck (pending final confirmation)

3:00pm - 3:30pm30 mins

Development of Emerging Cell & Gene Therapies

Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing - Unlocking Efficiency, Control and Scalability

Kat Kozyrytska - Managing Director, Kozyrytska Consulting

3:00pm - 3:30pm30 mins

Cell Therapy Manufacturing & Analytics

Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing - Unlocking Efficiency, Control and Scalability

Kat Kozyrytska - Managing Director, Kozyrytska Consulting

3:00pm - 3:30pm30 mins

Gene Therapy Manufacturing & Analytics

Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing - Unlocking Efficiency, Control and Scalability

Kat Kozyrytska - Managing Director, Kozyrytska Consulting

3:30pm - 3:35pm5 mins

BPI Keynote Plenary

Chairperson Opening Remarks

3:35pm - 4:10pm35 mins

BPI Keynote Plenary

PLENARY KEYNOTE: Overcoming Challenges in Vaccine Manufacturing and Distribution

Colette Ranucci - Vice President, Global Large Molecules, Technical Operations, Merck

4:10pm - 4:15pm5 mins

Break

Close of Conference

* 活动内容有可能不事先告知作更动及调整。

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Analytical, Quality and Characterization

Cell Culture & Upstream Processing

Cell Line Development & Engineering

Cell Therapy Manufacturing & Analytics

Development of Emerging Cell & Gene Therapies

Downstream Processing

Gene Therapy Manufacturing & Analytics

Manufacturing Strategy & Digitalization

Registration Break