TUESDAY, AUGUST 16 | 10:45 – 11:30am
Considerations in Successful Scale-Up of Cell Culture Processes from Bench to GMP Production
Susan D. Jones, PhD, Chief Technical Officer, Tourmaline Bio
- How representative are different small scale process development models?
- Factors to incorporate in planning scale-up of cell culture processes
- Discuss selected case studies of successful and unsuccessful scale-up
- Do different CHO hosts have different responses and considerations during scale-up? What are some typical areas of concern for CHO cells?
Process Intensification – When and Where Is It Appropriate?
Ricardo J.S. Silva, PhD, Senior Scientist, Downstream Process Development, Animal Cell Technology, iBET Instituto de Biologia Experimental Tecnologica
- Lessons learned from mAbs, can we use them for gene therapy products?
- What tools are out there to enable process integration? What are the current needs for USP, DSP, and process control?
- New opportunities and challenges along the road with new modalities
PAT and Process Intensification - Finding the Tools to De-Risk the Process
Jennifer Zhang, Senior Engineer, Biogen
- In-line, at-line, off-line: what is the right fit and where in the process?
- How to control/monitor bioreactor excursions for material diversion - characterizing and understanding residence time distribution to minimize impact to productivity
- Real-time release to alleviate analytical strain and sub-batching strategies
CMC Challenges for Cell Therapies
Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.
- Comparability following process change
- Potency Assay
- Quality Control
New Directions for HCP Detection, Analysis and Control
Abraham M. Lenhoff, PhD, AP Colburn Professor, Chemical & Biomolecular Engineering, University of Delaware
- ELISA vs. LC-MS: current status and prospects
- Methods for enhancing HCP detection
- New technologies for HCP clearance
- HCP control in non-mAb products
Stability and Developability of Novel Modalities
Bharathi Vellalore, PhD, Scientist, Biotherapeutics Drug Product Development, Janssen
- Analytical methods for high concentration biologics and cell and gene therapies
- Phase appropriate methods for process monitoring and control
- Analytical methods for drug products characterization
- Stability and impurities in novel modalities
Production of Vaccines in a Closed System
Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)
- Production technologies for large viruses and vaccines
- Sterile interconnection of unit operations
- Testing/validation of sterility of the production system
THURSDAY, AUGUST 18 | 11:00am – 12:00pm
Smart Manufacturing and Bioprocessing Excellence
Robert F. Dream, PhD, Managing Director, HDR Co. LLC
- The rapid adoption of intelligent manufacturing and Industry 4.0/Pharma 4.0
- How to integrate digital tools in bioprocessing design and optimization?
- How to achieve smart manufacturing and contamination control strategies?
- How to integrate flexible networks, cutting-edge innovation in a quality culture
- Continuous process verification and manufacturing (CPV-M) in a new paradigm shift (US-FDA vs EU-EMA)
- AI-enabled proactive quality response – Is it applicable?
Vaccine/Bioprocess Development Opportunities From Digitalization
Antonio G. Cardillo, PhD, Senior Scientist, GSK
- Digital twin: definition, application, and how to create one
- Monitoring and controlling Vaccine bioprocesses the challenge and opportunity to create a reliable data pipeline
- Process Analytical Technologies (PAT), how and when its use generate a return of investment
Advances and Challenges in Protein Purification
Maria Lorenzo, Principal Scientific Researcher, Protein Chemistry, Genentech, Inc.
- Challenges in the high throughput purification of intracellular proteins
- Elements of a robust protein purification platform
- High throughput in protein stability determination
- New technologies in protein purification and processes
Non-Viral Gene Therapy Development
Meisam Bakhshayeshi, PhD, Senior Director and Head, Process Development, Intergalactic Therapeutics
- Non-Viral Gene Therapy Approaches
- Available Platforms
- Delivery Mechanisms
- Challenges
Manufacturing Challenges for Cell-based Therapies
Patrick J. Hanley, PhD, Assistant Research Professor, Pediatrics & Director, GMP for Immunotherapy & Cellular Lab Therapy, Children's National Health System
- Process Development
- Scaling issues
- Emerging Challenges
Opportunities and Challenges in Analytical Method Lifecycle Management (AMLM)
Chengdong (Jason) Xu, PhD, Senior Scientist, Merck
- Platform method and phase-appropriate analytical method development
- Current challenges in IPC, QC release and extended characterization
- Emerging techniques for IPC, QC release and extended characterization
- Method validation strategy
Advantages and Disadvantages of Machine Learning Approach for Antibody Stability Prediction
Pin-Kuang Lai, PhD, Assistant Professor, Department of Chemical Engineering and Materials Science, Stevens Institute of Technology
- Machine learning algorithms for small data
- Feature creation and selection for antibody
- Apply the machine learning protocol to a new platform
Non-Viral Gene Therapy Development
Meisam Bakhshayeshi, PhD, Senior Director and Head, Process Development, Intergalactic Therapeutics
- Non-Viral Gene Therapy Approaches
- Available Platforms
- Delivery Mechanisms
- Challenges