September 15-18, 2025
Hynes Convention CenterBoston, USAKey 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
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Monday 15th September: Pre-Conference Day - ET (Eastern Time, GMT-05:00)
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Monday 15th September: Pre-Conference Day - ET (Eastern Time, GMT-05:00)
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Streams
Showing 1 of 1 Streams
Registration Break
8:00am - 8:50am
Registration and Morning Coffee
Showing 4 of 4 Streams
Workshop 1: CMC Roadmap
Workshop 2: Intensified & Continuous Processing
Workshop 3: Beyond mAbs
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
- Amit Kumar - Senior Bioprocess Advisor (Independent), Formerly Moderna
9:00am - 9:40am
KEYNOTE: From Vision to Reality: Delivering Speed and On-Demand Capacity at Low Cost through High-Productivity Integrated Continuous Bioprocessing
- Christopher Hwang - Executive Vice President & CTO, Transcenta Therapeutics/HJB
9:40am - 10:10am
Cleaner Perfusion Culture with Novel Filter that Reduces Host Cell Proteins (HCPs)
- Shireen Goh - Associate Professor, Singapore University of Technology & Design (SUTD)
10:10am - 10:30am
Morning Break
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
Morning Break
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 4 of 4 Streams
Workshop 1: CMC Roadmap
Workshop 2: Intensified & Continuous Processing
Workshop 3: Beyond mAbs
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: Process Modelling and Control Strategy for Continuous Upstream Processing
- How does continuous differ fundamentally from batch in terms of process modeling requirements?
- What has been your biggest challenge when implementing model predictive control in upstream bioprocesses?
- Key process parameters (CPPs) and critical quality attributes (CQAs) in continuous upstream bioprocessing.
- Real-time monitoring: role of PAT (Process Analytical Technology) tools, sensors, and soft sensors.
- Advanced control techniques: MPC (Model Predictive Control), adaptive control, and reinforcement learning.
- Integration of control strategies with digital twins for predictive optimization
- Data requirements for robust models – balancing high-frequency vs. low-frequency measurements.
- Scaling continuous upstream processes while maintaining fidelity of the model
- Charles Sardonini, PhD - Consultant to the Biotechnology Industry, Sardonini Consulting, LLC
- Brooke Tam - Process Engineer IV, Sanofi
- Ujwal Patil - Associate Director, Biopharmaceutical Development, AstraZeneca
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 - 12:00pm
Digitalization in Bioprocessing
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
Showing 1 of 1 Streams
Break
12:00pm - 1:00pm
Lunch
Showing 4 of 4 Streams
Workshop 1: CMC Roadmap
Workshop 2: Intensified & Continuous Processing
Workshop 3: Beyond mAbs
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
Afternoon Break
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
Afternoon Break
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
- Kat Kozyrytska - Consultant, AI Implementation & Tech Commercialization
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 4 of 4 Streams
Workshop 1: CMC Roadmap
Workshop 2: Intensified & Continuous Processing
Workshop 3: Beyond mAbs
Workshop 5: BPI School
3:00pm - 4:00pm
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
4:00pm - 4:30pm
Final Q&A Session & Closing Remarks
- 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 modalities such as bi/multi-specifics, ADCs, 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.
- Marco Lobba - CEO, CatenaBio
- David Humphreys, PhD - Executive Director and Head of Antibody and Novel Therapeutics, UCB Pharma
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
4:30pm - 4:35pm
Close of Pre-Conference day
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