Breakout Discussion Groups

Breakout discussions provide an opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges.

TUESDAY, AUGUST 16 | 10:45 – 11:30am

Optimizing Cell Line and Cell Culture Processes

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?

Integrated Continuous Processing

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​​

Cell Therapy CMC & Analytics

CMC Challenges for Cell Therapies
Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.

  • Comparability following process change
  • Potency Assay
  • Quality Control

Host Cell Proteins

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

Rapid Methods to Access Stability and Impurities in Biologics

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

Vaccine Development and Manufacturing

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

Bioproduction: Smart Biomanufacturing and Digitalization

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 in Purification & Recovery

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​

Gene Therapy Manufacturing

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

Cell Therapy Manufacturing

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

Accelerating Analytical Development

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

Formulation and Delivery of Biologics and New Modalities

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

mRNA-Based Therapeutics

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