Key Sessions

Christopher Hwang

KEYNOTE: Shaping the Future of Biomanufacturing: How Ultra-High Productivity Perfusion Integrated with a Hybrid Continuous DSP Platform Enable Speed, Cost Efficiency, and On-Demand Capacity

Transcenta Therapeutics/HJB

Monday 15th September: Pre-Conference DayMonday, 15 September 2025 - ET (Eastern Time, GMT-05:00)

8:00am - 8:50am50 mins

Registration Break

Registration and Morning Coffee

8:50am - 9:00am10 mins

Workshop 1: CMC Roadmap

Extended Chairperson’s Workshop Opening

8:50am - 9:00am10 mins

Workshop 2: Intensified & Continuous Processing

Extended Chairperson’s Workshop Opening

8:50am - 9:00am10 mins

Workshop 3: Beyond mAbs

Extended Chairperson’s Workshop Opening

8:50am - 9:00am10 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Extended Chairperson's Workshop Opening

8:50am - 9:00am10 mins

Workshop 5: BPI School

Extended Chairperson’s Workshop Opening

9:00am - 10:30am90 mins

Workshop 1: CMC Roadmap

Setting the Scene : CMC Studies in the life cycle

Thomas Chattaway - Senior Life Science Consultant, Independent
Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L

9:00am - 9:30am30 mins

Workshop 2: Intensified & Continuous Processing

KEYNOTE: Shaping the Future of Biomanufacturing: How Ultra-High Productivity Perfusion Integrated with a Hybrid Continuous DSP Platform Enable Speed, Cost Efficiency, and On-Demand Capacity

Christopher Hwang - Executive Vice President & CTO, Transcenta Therapeutics/HJB

9:00am - 9:30am30 mins

Workshop 3: Beyond mAbs

The Valley of Death: Mastering CMC Challenges in the Development of Novel Biotherapeutics

Matthias Müllner - CEO, bespark*bio

9:00am - 9:30am30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Next Generation Upstream - Host Options

Giovanna Iosca - Fermentation Specialist, Department of Biotechnology and Biomedicine, Technical University of Denmark

9:00am - 9:45am45 mins

Workshop 5: BPI School

Introduction to Upstream Manufacturing

Michael Butler - Principal Investigator, Cell Technology, NIBRT

9:30am - 10:00am30 mins

Workshop 2: Intensified & Continuous Processing

Cleaner Perfusion Culture with Novel Filter that Reduces Host Cell Proteins (HCPs)

Shireen Goh - Associate Professor, Singapore University of Technology & Design (SUTD)

9:30am - 10:00am30 mins

Workshop 3: Beyond mAbs

Bispecific molecule engineering strategies and impact on and fit with manufacturing strategy

David Humphreys, PhD - Executive Director and Head of Antibody and Novel Therapeutics, UCB Pharma

9:30am - 10:00am30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Next Generation Upstream - Highthroughput and Predictive Methods for Improving Recombinant Protein Titres in Microbes

Nathan Crook - Assistant Professor, NC State University

9:45am - 10:30am45 mins

Workshop 5: BPI School

Introduction To Downstream Manufacturing

Stefano Menegatti - Associate Professor, North Carolina State University

10:00am - 10:30am30 mins

Workshop 2: Intensified & Continuous Processing

Spotlight Presentation - Calling all Technology Thought Leaders!

10:00am - 10:30am30 mins

Workshop 3: Beyond mAbs

Spotlight Presentation - Calling all Technology Thought Leaders!

10:00am - 10:30am30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Spotlight Presentation - Calling all Technology Thought Leaders!

10:30am - 11:00am30 mins

Break

Morning Break

11:00am - 12:00pm60 mins

Workshop 1: CMC Roadmap

Requirements from Pre-Clinical to Phase 2 CT

Thomas Chattaway - Senior Life Science Consultant, Independent
Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L

11:00am - 12:00pm60 mins

Workshop 2: Intensified & Continuous Processing

Round Tables: Challenges with Continuous Processing

Charles Sardonini - Consultant to the Biotechnology Industry, Sardonini Consulting, LLC

11:00am - 11:30am30 mins

Workshop 3: Beyond mAbs

Utilizing computer-aided design to optimize the manufacturability of multi-specific therapeutic antibodies

Yue Liu, PhD - CEO, Ab Studio Inc.

11:00am - 11:30am30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Future targets - bispecific antibodies

Steffen Goletz, PhD - Full Professor, Head of Biotherapeutic Glycoengineering and Immunology - Institute for Biotechnology & Biomedicine, Danish Technical University

11:00am - 12:00pm60 mins

Workshop 5: BPI School

Digitalization in Bioprocessing

Mark Duerkop - Chief Executive Officer, Novasign, Austria

11:30am - 12:00pm30 mins

Workshop 3: Beyond mAbs

ADCs and Beyond in Radiopharmaceuticals

Jarrod Longcor - Chief Operating Officer, Cellectar Biosciences

11:30am - 12:00pm30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Host Cell Protein Profiling To Understand Process Change

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

12:00pm - 1:00pm60 mins

Break

Lunch

1:00pm - 2:00pm60 mins

Workshop 1: CMC Roadmap

Requirements from Pre-Clinical to Phase 2 CT

Thomas Chattaway - Senior Life Science Consultant, Independent
Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L

1:00pm - 1:30pm30 mins

Workshop 2: Intensified & Continuous Processing

Scaling Tangential Flow Filtration for Continuous Manufacturing via High Flux, High-Capacity Filtration and Operational Method Optimization

1:00pm - 1:30pm30 mins

Workshop 3: Beyond mAbs

Optimizing Early-Stage ADC Design and Process Development for Streamlined Manufacturing

Engin Ayturk - Senior Director, CMC BioConjugation, Process Development & Manufacturing, Exelixis

1:00pm - 1:30pm30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Next generation downstream - possibility of an all membrane process

Stefano Menegatti - Associate Professor, North Carolina State University

1:00pm - 2:00pm60 mins

Workshop 5: BPI School

An Introduction to Emerging Therapies: Unlocking the Future of Medicine

1:30pm - 2:00pm30 mins

Workshop 2: Intensified & Continuous Processing

Integrated Continuous USP Platform for Maximum Productivity and Closed-loop Controlled CQA

Jaeweon Lee, Ph.D - Student, University of Massachusetts Lowell

1:30pm - 2:00pm30 mins

Workshop 3: Beyond mAbs

Enabling Dual-Payload ADCs: novel conjugation strategies and payload selection criteria

Marco Lobba - CEO, CatenaBio

1:30pm - 2:00pm30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Next generation integrated process

John Woodley - Professor, Department of Chemical and Biochemical Engineering, Technical University Denmark

2:00pm - 2:30pm30 mins

Workshop 1: CMC Roadmap

Requirements from Pre-Clinical to Phase 2 CT

Thomas Chattaway - Senior Life Science Consultant, Independent
Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L

2:00pm - 2:30pm30 mins

Workshop 2: Intensified & Continuous Processing

Spotlight Presentation - Calling all Technology Thought Leaders!

2:00pm - 2:30pm30 mins

Workshop 3: Beyond mAbs

Spotlight Presentation - Calling all Technology Thought Leaders!

2:00pm - 2:30pm30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Spotlight Presentation - Calling all Technology Thought Leaders!

2:00pm - 2:30pm30 mins

Workshop 5: BPI School

Analytical & Quality PART 1

2:30pm - 3:00pm30 mins

Break

Afternoon Break

3:00pm - 4:00pm60 mins

Workshop 1: CMC Roadmap

Case Study & Group Exercise

Thomas Chattaway - Senior Life Science Consultant, Independent
Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L

3:00pm - 3:30pm30 mins

Workshop 2: Intensified & Continuous Processing

Enabling robust continuous biomanufacturing using Digital Twins

Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria

3:00pm - 3:30pm30 mins

Workshop 3: Beyond mAbs

CMC Strategies for Advanced ADC Manufacturing

3:00pm - 3:30pm30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Next generation support technologies - digital twins

Krist V. Gernaey - Professor, Technical Univirtsity of Denmark

3:00pm - 3:30pm30 mins

Workshop 5: BPI School

Analytical & Quality PART 2

3:30pm - 4:00pm30 mins

Workshop 2: Intensified & Continuous Processing

CMC Considerations for Continuous Bioprocess Design, Development, and Manufacturing

Yanhuai Ding - Sr . Director, CMC DS/DP, Evolve Immune Therapeutics

3:30pm - 4:00pm30 mins

Workshop 3: Beyond mAbs

PANEL: The Next Frontier - Integrating Design, Manufacturability, and Strategy for Next-Gen Biologics

3:30pm - 4:00pm30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Next generation support technologies - analytics

Michael Daniele - Associate Professor, Department of Electrical & Computer Engineering, NC State University

3:30pm - 4:00pm30 mins

Workshop 5: BPI School

BPI School Round Up

Michael Butler - Principal Investigator, Cell Technology, NIBRT
Stefano Menegatti - Associate Professor, North Carolina State University
Mark Duerkop - Chief Executive Officer, Novasign, Austria

4:00pm - 4:30pm30 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Educational support to implement the next generation of processes

Gary Gilleskie - BTEC’s Executive Director, NC State University

4:30pm - 4:45pm15 mins

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Wrap Up Q & A

4:45pm - 4:50pm5 mins

Break

Close of Pre-Conference day

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

Filter

Streams

BPI School

Beyond mAbs

Break

CMC Roadmap

Integrated Biomanufacturing

Intensified & Continuous

Registration Break