会前研讨会 座谈会
会前研讨会 座谈会
8:00am - 8:50am50 mins
Coffee and Registration
Pre-Conference Symposium: Cell Line Development & Engineering
8:50am - 9:00am10 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Chairperson’s Opening Remarks
- Alessandro Mora - Principal Scientist, CMC Operations, Jounce Therapeutics
9:00am - 9:30am30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Advances In Cell Line Development And Process Development To Speed Mab And Non Mab Assets Faster To Clinic
- Anurag Khetan - Site Director, Biologics Process Development, Bristol-Myers Squibb
9:30am - 10:00am30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Streamlining Early Cell Line Development to Increase Speed and Efficiency
- Thomas Jostock, PhD - New Technologies Network Leader/Novartis Leading Scientist, Novartis
10:00am - 10:30am30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Optimizing Cell Line Development with Beacon®: On-Chip Cloning Technology To Improve Performance And Reduce Timelines
- Rachel Ferguson - Associate Scientist III, Proteins Cell Line Development, Biogen
Pre-Conference Symposium: Raw Materials
9:20am - 9:30am10 mins
Pre-Conference Symposium: Raw Materials
Chairperson’s Opening Remarks
- Jeanet S.K. Kring - Senior Development Scientist, CMC API GMP Material Responsible, Novo Nordisk A/S, Denmark
9:30am - 10:00am30 mins
Pre-Conference Symposium: Raw Materials
Overview of BioPhorum Raw Material Variability (RMV) Workstream
- Chiali Liu, Ph.D. - Principal Scientist, Janssen Supply Chain
- Julian Goy - Facilitator, BioPhorum
10:00am - 10:30am30 mins
Pre-Conference Symposium: Raw Materials
Digitization of Raw Material Data and The Application of Data Analytics to Better Understand and Control Variation
- Susan Burke, Ph.D. - Director Process Development, Amgen
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
8:50am - 9:00am10 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Chairperson’s Opening Remarks
- James Colandene, Ph.D. - Manager, Biopharmaceutical Product Sciences, GSK
9:00am - 9:30am30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Annex 1 Draft/Preventing Contamination and Cross Contamination during Aseptic Fill-Finish
- Richard Denk - Senior Consultant Aseptic Processing & Containment., SKAN AG
9:30am - 10:00am30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Mitigating Particle Problems During Biopharmaceutical Formulation, Storage, and Use
- James Colandene, Ph.D. - Manager, Biopharmaceutical Product Sciences, GSK
10:00am - 10:30am30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Challenges And Complexities Related To The Development Of A Lyophilized Drug Product For An Acute Neurology Indication: A Case Study
- Deirdre Lowe - Senior Engineer, Protein Pharmaceutical Development, Biogen
Pre-Conference Symposium: PAT and Advanced Process Control
8:50am - 9:00am10 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Chairperson's opening Remarks
9:00am - 9:30am30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
PAT in Freeze Drying - Measurement of Residual Moisture Content by Non-Invasive Methods
- Richard Affleck - Scientist, Sanofi Genzyme
9:30am - 10:00am30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Using Raman Spectroscopy for Monitor and Control of Critical Quality Attributes in Ultrafiltration/Diafiltration of Biotherapeutics
- Christina Passno - Process Development Engineer III, Regeneron Pharmaceuticals, Inc.
10:00am - 10:30am30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Accurate Biomass Soft-Sensor Using 2-D Fluorescence and MARS Modeling
- Mark Durkop - Scientist Department of Biotechnology and Co-Founder of “Novasign”, University of Natural Resources and Life Sciences/ Novasign
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
8:50am - 9:00am10 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Chairperson’s Opening Remarks
9:00am - 9:30am30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Development of Tissue Therapies as compared to the Development of Cell and Gene Therapies: A Look Back, A Look Ahead
- Jennifer Briggs Braswell, PhD - Chief Administrative Officer, ARMI, BioFab, USA
9:30am - 10:00am30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Raw Materials/Starting Materials
- Derek Hei - Senior VP, Manufacturing, Quality & Regulatory, BlueRock Therapeutics, USA
10:00am - 10:30am30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Cell Culture and Expansion
- Taby Ahsan - Director of Development, RoosterBio Inc., USA
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
8:50am - 9:00am10 mins
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Chairperson's Opening Remarks
- James Dean Vogel - Founder and Director , The BioProcess Institute
9:00am - 10:30am90 mins
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
8:50am - 10:20am90 mins
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
- Thomas Zahel - Head of Innovation, Exputec
10:30am - 11:00am30 mins
Networking Refreshment Break
Pre-Conference Symposium: Cell Line Development & Engineering
11:00am - 11:30am30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Anticipating Cell Lines Challenges for CMC Readiness
- Alessandro Mora - Principal Scientist, CMC Operations, Jounce Therapeutics
11:30am - 12:00pm30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
High Performance Accelerated Cell Line Development at Samsung BioLogics
- John E. Gill IV - Director, Cell Line Development, Samsung BioLogics
12:00pm - 12:30pm30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Consistently Delivering Outperforming Cell Lines Leveraging Extensive CLD Expertise and Innovative Seeding Platform
- Camille Evenou - Scientist, Celonic AG
Pre-Conference Symposium: Raw Materials
11:00am - 11:30am30 mins
Pre-Conference Symposium: Raw Materials
Understanding and Controlling the Impact of Elemental Impurities in Cell Culture
- Thomas Matthews - Scientist II, Biogen
11:30am - 12:00pm30 mins
Pre-Conference Symposium: Raw Materials
Media Raw Material Variability: Case Studies in Different Stages of Product Lifecycle
- Divya Vasudevan - Engineer II, Pharma Innovation, Technology and MSAT, Genentech
12:00pm - 12:30pm30 mins
Pre-Conference Symposium: Raw Materials
Networking Luncheon
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
11:00am - 11:30am30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Syringe Filling of a High-Concentration mAb Formulation: Issues and Mitigation Strategies
- Kashappa-Goud Desai - Scientific Leader, Biopharmaceutical Product Sciences, GSK
11:30am - 12:00pm30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Feasibility of Frozen BDS Storage Of Ultra-High Concentration mAbs
- Eric Falcone - Development Scientist I, Pharmaceutical Development, Alexion
12:00pm - 12:30pm30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
The Effect of Surfactant Excipients on the Stabilization of Proteins during Mechanical, Oxidative and Thermal Stress
- Frank Romanski, Ph.D - Head of Global Marketing, BASF
Pre-Conference Symposium: PAT and Advanced Process Control
11:00am - 11:30am30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Real-time titer measurement methods to control Protein A column loading during continuous antibody production - a technology overview
- Jeff Goby - Scientist II, Boehringer Ingelheim
11:30am - 12:00pm30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Evaluation of PAT Co-Laboratory Process Development Model
- Zachary Houle - Senior Development Specialist, Upstream Process Development, Takeda
12:00pm - 12:30pm30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Networking Luncheon
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
11:00am - 11:30am30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Cell Culture and Expansion
- Bruce A Bunnell - Professor, Director of the Tulane Center for Stem Cell Research & Regenerative Medicine, USA
11:30am - 12:00pm30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Scaffold Fabrication - 3D Printing
12:00pm - 12:30pm30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Biomaterial Scaffold Fabrication - Additive Manufacturing Materials and Methods
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
11:00am - 12:30pm90 mins
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
11:00am - 12:30pm90 mins
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle - Cont'd
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
- Thomas Zahel - Head of Innovation, Exputec
12:30pm - 1:30pm60 mins
Networking Luncheon
Pre-Conference Symposium: Cell Line Development & Engineering
1:30pm - 2:00pm30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Accelerating Timelines through Implementation of TLA Sequencing in Cell Line Selection
- Marieke Koedood Zhao - Director, Cell Line Development, Mersana Therapeutics
2:00pm - 2:30pm30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Further Streamlining CLD: Combining Single Cell Cloning and Enrichment using FACS into Semi-Solid Media
- Eric Lee - Associate Scientist II, Cell Culture Development, Biogen
2:30pm - 3:00pm30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Trypan Blue vs. Dual-Fluorescence Nuclear Stains: Systematic Experimental Design for Cell Concentration and Viability Method Selection
- Jean Qiu - Chief Technology Officer, Founder, Nexcelom Bioscience
Pre-Conference Symposium: Raw Materials
1:30pm - 2:00pm30 mins
Pre-Conference Symposium: Raw Materials
Raw Material Control Strategies: From User Requirements to Design of Specifications
- Tatsiana Mironava - Senior Specialist Technical Specifications, Amgen
2:00pm - 2:30pm30 mins
Pre-Conference Symposium: Raw Materials
Development of A Holistic Approach to Raw Material Risk Assessments Through Industry Collaboration
- Kara Quinn - Global Technical Operations Raw Material Center of Excellence, Merck & Co., Inc
2:30pm - 3:00pm30 mins
Pre-Conference Symposium: Raw Materials
Qualification of Raw Material for Clinical Trials
- Jeanet S.K. Kring - Senior Development Scientist, CMC API GMP Material Responsible, Novo Nordisk A/S, Denmark
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
1:30pm - 2:00pm30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Overcoming Challenges in Developing Subcutaneous Formulations for Biologics
- Arvind Srivastava, PhD - Vice President, Avantor, Inc.
2:00pm - 2:30pm30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Challenges and Strategies for Low-Dose Drug Product Development During In-Use Administration Studies
- Apurva More - Scientist, Global Pharmaceutical Development Biologics, Sanofi
2:30pm - 3:00pm30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Cyclodextrins as a functional alternative to polysorbates within biologic formulations.
- Peter Ferguson - Global Market Manager, ROQUETTE
Pre-Conference Symposium: PAT and Advanced Process Control
1:30pm - 2:00pm30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Enhancing Process Optimization Using Advanced Analytical and Data Handling
- Melvin Koch - Principal Scientist, CPAC, University of Washington
2:00pm - 2:30pm30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Development and Implementation of a PAT System in GMP for Real-Time Manufacturing Process Monitoring and Control
- Ting-Kuo Huang, PhD - Principal Engineer, Genentech
2:30pm - 3:00pm30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Investigating USP & DSP Tools For Analysis: Round Table:
- Christina Passno - Process Development Engineer III, Regeneron Pharmaceuticals, Inc.
- Mark Durkop - Scientist Department of Biotechnology and Co-Founder of “Novasign”, University of Natural Resources and Life Sciences/ Novasign
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
1:30pm - 2:00pm30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Scaffold Fabrication Using 3D Printing
2:00pm - 2:30pm30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Tissue Maturation and Bioreactor Culture
2:30pm - 3:00pm30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Tissue Maturation and Bioreactor Culture
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
1:30pm - 3:00pm90 mins
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
1:30pm - 3:00pm90 mins
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle - Cont'd
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
- Thomas Zahel - Head of Innovation, Exputec
3:00pm - 3:30pm30 mins
Networking Refreshment Break
Pre-Conference Symposium: Cell Line Development & Engineering
3:30pm - 4:30pm60 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Panel Discussion: Integrating New Engineering and Cell Line Development Technologies into Established Workflows
- Anurag Khetan - Site Director, Biologics Process Development, Bristol-Myers Squibb
- Michael Brem - Senior Scientist, Cell Line Development, Cytovance Biologics Inc.
- Jean Qiu - Chief Technology Officer, Founder, Nexcelom Bioscience
- Marieke Koedood Zhao - Director, Cell Line Development, Mersana Therapeutics
Pre-Conference Symposium: Raw Materials
3:30pm - 4:00pm30 mins
Pre-Conference Symposium: Raw Materials
From Sequence to Product in Hours - Cell Free Expression for Next-Generation Therapeutics
- Philip Probert, PhD - Senior Upstream Scientist, CPI Biologics
4:00pm - 4:30pm30 mins
Pre-Conference Symposium: Raw Materials
End of Symposium
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
3:30pm - 4:00pm30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
In Pursuit of Robust Drug Product Manufacturing Process for mAbs
- Omkar Dhamale, Ph.D. - Research Investigator, Drug Product Technologies, Incyte
4:00pm - 4:30pm30 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
End of Symposium
Pre-Conference Symposium: PAT and Advanced Process Control
3:30pm - 4:00pm30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Smart Data Analytics for Biomanufacturing Process Modeling and Advanced Process Control
- Richard Braatz, PhD - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology
4:00pm - 4:30pm30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
End of Symposium
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
3:30pm - 4:00pm30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Magic on Ice: Ice-free cryopreservation at high-sub zero temperature for advanced CGT processing
4:00pm - 4:30pm30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Process Development Through multiomic platform
4:30pm - 5:00pm30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Data Management and Process Optimization Software
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
3:30pm - 5:00pm90 mins
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
- James Dean Vogel - Founder and Director , The BioProcess Institute
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
3:30pm - 5:00pm90 mins
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle - Cont'd
- Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
- Thomas Zahel - Head of Innovation, Exputec
5:00pm - 5:05pm5 mins
End of Pre-Conference Symposia
* 活动内容有可能不事先告知作更动及调整。