Key Sessions

Christopher Hwang

KEYNOTE: From Vision to Reality: Delivering Speed and On-Demand Capacity at Low Cost through High-Productivity Integrated Continuous Bioprocessing

Transcenta Therapeutics/HJB

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

Showing 1 of 1 Streams

Registration Break

8:00am - 8:50am

Registration and Morning Coffee

Showing 5 of 5 Streams

Workshop 1: CMC Roadmap

Workshop 2: Intensified & Continuous Processing

Workshop 3: Beyond mAbs

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Workshop 5: BPI School

8:50am - 9:00am

Extended Chairperson’s Workshop Opening

9:00am - 10:30am

Setting the Scene : CMC Studies in the life cycle

Introduction
Objectives and outline of course
Main development stages and regulatory cadre
The main streams of activity from cell line to drug product
The CTD for Regulatory filings. Quality Module – overview of main sections
The importance of CMC : Quality (and Safety and Efficacy)
Supply
The pillars of pharmaceutical development
Criticality Assessment
Control strategy & Validation
QBD Principles
Most relevant regulatory Guidance and where to find it MH

Quiz

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

8:50am - 9:00am

Extended Chairperson’s Workshop Opening

9:00am - 9:30am

KEYNOTE: From Vision to Reality: Delivering Speed and On-Demand Capacity at Low Cost through High-Productivity Integrated Continuous Bioprocessing

Continuous biomanufacturing enhances productivity, control, cost efficiency, and sustainability. We implemented a late-stage hybrid continuous biomanufacturing platform achieving >10-fold productivity gains via high-intensity perfusion (up to 8 g/L-day), integrated with single-use Protein A capture and fully automated flow-through polishing system. We will share our development and implementation strategy, key learnings, and a case study demonstrating successful deployment at manufacturing scale.

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

9:30am - 10:00am

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

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

10:00am - 10:30am

Spotlight Presentation – Calling all Technology Thought Leaders!

8:50am - 9:00am

Workshop Opening

Matthias Müllner - CEO, bespark*bio

9:00am - 9:30am

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

Matthias Müllner - CEO, bespark*bio

9:30am - 10:00am

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

10:00am - 10:30am

Spotlight Presentation – Calling all Technology Thought Leaders!

8:50am - 9:00am

Extended Chairperson's Workshop Opening

9:00am - 9:30am

Next Generation Upstream - Host Options

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

9:30am - 10:00am

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

Nathan Crook - Assistant Professor, NC State University

10:00am - 10:30am

Spotlight Presentation – Calling all Technology Thought Leaders!

8:50am - 9:00am

Extended Chairperson’s Workshop Opening

9:00am - 9:45am

Introduction to Upstream Manufacturing

Michael Butler - Principal Investigator, Cell Technology, NIBRT

9:45am - 10:30am

Introduction To Downstream Manufacturing

Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University

Showing 1 of 1 Streams

Break

10:30am - 11:00am

Morning Break

Showing 5 of 5 Streams

Workshop 1: CMC Roadmap

Workshop 2: Intensified & Continuous Processing

Workshop 3: Beyond mAbs

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Workshop 5: BPI School

11:00am - 12:00pm

Requirements from Pre-Clinical to Phase 2 CT

Review of the main streams and initial status
Broad requirements for Tox and for First in Human Studies
Cell banking
Other Raw materials
Drug Substance Process and Manufacture
Minimum requirements
Understanding your process :
Impurities : identity, clearance, control
First steps towards a control strategy
Adventitious contamination and Viral Clearance Studies
Drug formulation and Drug Product Processing
Analytical package
Release methods definition and development
From method performance to method validation
In Process Controls (else cover under process?)
Batch data in the submission
Product Characterisation and Reference standard
Stability ( DS and DP)
Forced degradation studies : necessity and importance
Why is stability important ?
Different type of stability studies and typical package for PhI
Shelf life assignment

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

11:00am - 12:00pm

Round Tables: Challenges with Continuous Processing

Round Table 1: Scaling CP: From Bench to Plant

What breaks between lab-scale CP and full-scale implementation?
What scale counts as “commercially viable” for CP?
What's missing in current tech to make this easier

Round Table 2: The Business Case for Hybrid and CP Models

How do you model ROI on continuous or hybrid investments?
What incentives drive adoption (speed, cost of goods, flexibility)?
When is it worth revisiting old filings to modernize an existing process?

Round Table 3: Continuous But Flexible: Connected vs Fully Continuous Systems

Is connected processing a stepping stone or an endpoint?
When is hybrid actually better than true CP?

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

11:00am - 11:30am

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

Yue Liu, PhD - CEO, Ab Studio Inc.

11:30am - 12:00pm

ADCs and Beyond in Radiopharmaceuticals

Jarrod Longcor - Chief Operating Officer, Cellectar Biosciences

11:00am - 11:30am

Future targets – bispecific antibodies

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

11:30am - 12:00pm

Host Cell Protein Profiling To Understand Process Change

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

11:00am - 12:00pm

Digitalization in Bioprocessing

Mark Duerkop - Chief Executive Officer, Novasign, Austria

Showing 1 of 1 Streams

Break

12:00pm - 1:00pm

Lunch

Showing 5 of 5 Streams

Workshop 1: CMC Roadmap

Workshop 2: Intensified & Continuous Processing

Workshop 3: Beyond mAbs

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Workshop 5: BPI School

1:00pm - 2:00pm

Requirements from Pre-Clinical to Phase 2 CT

Review of the main streams and initial status
Broad requirements for Tox and for First in Human Studies
Cell banking
Other Raw materials
Drug Substance Process and Manufacture
Minimum requirements
Understanding your process :
Impurities : identity, clearance, control
First steps towards a control strategy
Adventitious contamination and Viral Clearance Studies
Drug formulation and Drug Product Processing
Analytical package
Release methods definition and development
From method performance to method validation
In Process Controls (else cover under process?)
Batch data in the submission
Product Characterisation and Reference standard
Stability ( DS and DP)
Forced degradation studies : necessity and importance
Why is stability important ?
Different type of stability studies and typical package for PhI
Shelf life assignment

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

2:00pm - 2:30pm

Requirements from Pre-Clinical to Phase 2 CT

Anticipating the needs on the work streams
Process Understanding and Design
Technology Transfer
Dealing with changes and Comparability

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

1:00pm - 1:30pm

Process Intensification Evolution – Yesterday, Today and Tomorrow’s portfolio will shape the Future Operating landscape

Jonathon Romero - Distinguished Scientist, BioProcess Development & Mfg, Merck

1:30pm - 2:00pm

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

Jaeweon Lee, MSE - Student, University of Massachusetts Lowell

2:00pm - 2:30pm

Spotlight Presentation – Calling all Technology Thought Leaders!

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

1:00pm - 1:30pm

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

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

1:30pm - 2:00pm

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

Marco Lobba - CEO, CatenaBio

2:00pm - 2:30pm

Spotlight Presentation – Calling all Technology Thought Leaders!

Contact us today to learn more: Partners@informaconnectls.com

1:00pm - 1:30pm

Next generation downstream - possibility of an all membrane process

Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University

1:30pm - 2:00pm

Next generation integrated process

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

2:00pm - 2:30pm

Spotlight Presentation – Calling all Technology Thought Leaders!

1:00pm - 2:00pm

PANEL DISCUSSION: An Introduction to Emerging Therapies: Unlocking the Future of Medicine

Frank Riske, Ph.D. - Founder and Principal Consultant, Deep Dive Biotech Consulting

2:00pm - 2:30pm

Analytical & Quality PART 1

Kevin Zen, PhD - CMC Technical Operations, Opthea

Showing 1 of 1 Streams

Break

2:30pm - 3:00pm

Afternoon Break

Showing 5 of 5 Streams

Workshop 1: CMC Roadmap

Workshop 2: Intensified & Continuous Processing

Workshop 3: Beyond mAbs

Workshop 4: Accelerated Next Generation Manufacturing Workshop

Workshop 5: BPI School

3:00pm - 4:30pm

Case Study & Group Exercise

Gap analyses of the studies available to prepare a Phase 1 submission.
4 teams (Analytics, DS, DP, Materials) to cover different parts of case
30 – 45 min work in groups : Brief :
do the existing studies support a Phase 1 file and what are the risks involved?
Recommendation on eventual additional or superfluous studies
Map studies / data onto CTD modules (if time)
60 min debrief (15 min / group)
General Conclusions and End of Session

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

3:00pm - 3:30pm

Enabling robust continuous biomanufacturing using Digital Twins

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

3:30pm - 4:00pm

CMC Considerations for Continuous Bioprocess Design, Development, and Manufacturing

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

4:00pm - 4:30pm

From Data Stream to Control Scheme: Mastering Process Chemistry with MPC

Thomas Toupy - Scientist, Takeda

3:00pm - 3:30pm

From Antibodies to siRNA-Loaded Exosomes: AbbVie vs. NurExone in Advancing Spinal Cord Injury Treatments

Lior Shaltiel - CEO, NurExone Biologic

3:30pm - 4:15pm

ROUND-UP PANEL: The Future of Complex Biologics

Revisiting key challenges and the latest innovations in bi/multi-specifics, ADCs, and radiopharmaceuticals explored throughout the day.
Discussing game-changing strategies in engineering and process development for complex molecules.
Leveraging emerging technologies to accelerate the path to novel biologics.
Peering into the future of beyond-mAb formats and anticipating the next wave of industry breakthroughs.
Q&A

Matthias Müllner - CEO, bespark*bio
Yue Liu, PhD - CEO, Ab Studio Inc.

3:00pm - 3:30pm

Next generation support technologies - digital twins

Krist V. Gernaey - Professor, Technical Univirtsity of Denmark

3:30pm - 4:00pm

Next generation support technologies - analytics

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

4:00pm - 4:30pm

Educational support to implement the next generation of processes

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

4:30pm - 4:45pm

Wrap Up Q & A

3:00pm - 3:30pm

Analytical & Quality PART 2

Kevin Zen, PhD - CMC Technical Operations, Opthea

3:30pm - 4:00pm

BPI School Round Up

Michael Butler - Principal Investigator, Cell Technology, NIBRT
Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, North Carolina State University
Mark Duerkop - Chief Executive Officer, Novasign, Austria
Kevin Zen, PhD - CMC Technical Operations, Opthea

Showing 1 of 1 Streams

Break

4:45pm - 4:50pm

Close of Pre-Conference day

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

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