Key Sessions

Christopher Hwang

KEYNOTE: The Future of Biomanufacturing: How Ultra-High Productivity Perfusion & Integrated DSP Drive Speed, Cost Savings, and Just-in-Time Capacity

Transcenta Holdings

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: Tech Transfer for Biopharmaceutical Manufacturing

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: The Future of Biomanufacturing: How Ultra-High Productivity Perfusion & Integrated DSP Drive Speed, Cost Savings, and Just-in-Time Capacity

Christopher Hwang - Chief Technology Officer, Transcenta Holdings

9:00am - 9:30am30 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

9:00am - 10:30am90 mins

Workshop 4: Tech Transfer for Biopharmaceutical Manufacturing

Tech Transfer for Biopharmaceutical Manufacturing

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

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

Yue Liu, PhD - CEO, Ab Studio Inc.

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!

10:30am - 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

11:00am - 11:30am30 mins

Workshop 3: Beyond mAbs

ADCs and Beyond in Radiopharmaceuticals

Jarrod Longcor - Chief Operating Officer, Cellectar Biosciences

11:00am - 12:00pm60 mins

Workshop 4: Tech Transfer for Biopharmaceutical Manufacturing

Tech Transfer for Biopharmaceutical Manufacturing

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

Advanced Manufacturing Techniques for Radiopharmaceuticals

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

Ana Di Lillo - Scientist, AstraZeneca

1:00pm - 1:30pm30 mins

Workshop 3: Beyond mAbs

CMC Strategies for Advanced ADC Manufacturing

1:00pm - 2:30pm90 mins

Workshop 4: Tech Transfer for Biopharmaceutical Manufacturing

Tech Transfer for Biopharmaceutical Manufacturing

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

Site-Specific Conjugation Techniques for ADCs

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 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

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

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

3:00pm - 4:00pm60 mins

Workshop 4: Tech Transfer for Biopharmaceutical Manufacturing

Tech Transfer for Biopharmaceutical Manufacturing

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

Challenges in Scale-Up Production for ADCs

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 - 4:05pm5 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