Breakout Discussions

Engage in in-depth discussions with industry experts and your peers about the progress, trends and challenges you face in your research!

Interactive discussion groups play an integral role in networking with potential collaborators, provide an opportunity to share examples from your work, vet ideas with peers, and be part of a group problem-solving endeavor.

Discussion Topics & Moderators Include:

Biggest Challenges Today Limiting Scale-Up

Moderator: Jeffrey Chalmers, Ph.D., Professor, Chemical and Biomolecular Engineering, The Ohio State University

  • Clone selection?
  • Optimized media?
  • Different equipment/different sites?

 

Standardization Versus Customization of Disposables

Moderator: Stefan Schmidt, Ph.D., MBA., Senior Vice President, Process Science and Production, Rentschler Biotechnology

  • Lead times
  • Flexibility
  • Interchangeability
  • Inventory cost
  • Supplier sourcing
  • Quality control

 

Cell Engineering to Optimize Therapeutic Protein Production

Moderator Helene Faustrup Kildegaard, Ph.D., Senior Researcher and Co-Principal Investigator, The Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark

  • To which extent is cell engineering being applied to optimize protein production?
  • What is the potential of applying cell engineering?
  • Which technologies are being applied?
  • What are the concerns, hurdles and successes?

 

Continuous Biomanufacturing - An Implementation Consideration

Moderator: Robert Dream, Ph.D., Managing Director, HDR Company LLC. 

  • Will CB applicable to my process and operation?
  • Integrated Continuous Biomanufacturing
  • Hybrid “Batch-Continuous” Biomanufacturing
  • What type of equipment/system will I implement to accomplish the task
  • What type of control system will I implement to operate my process
  • Do I need any training for existing operation, QC, QA, Maintenance, Engineering, etc. personnel/departments
  • How do I perform my process validation
  • How do I define my batch and what will define my batch records?
  • As continuous Manufacturing requires continuous control of the process… what and how much of the data generated I save for future reference?

 

Engaging with Regulatory Agencies on Continuous Manufacturing

Moderator: Stephanie Krogmeier, Ph.D., Senior Director, Global Regulatory Affairs, Vertex Pharmaceuticals 

  • What have you found to be the most successful approach to engaging regulatory agencies or alternatively, can you provide an example of a mistake or misstep with respect to engaging Agencies?
  • What approaches have you tried to align across regulatory agencies?
  • What is the biggest challenge we face across the industry in our attempts to engage with Regulatory Agencies on Continuous Manufacturing?

 

Advanced Process Monitoring and Hybrid Modeling - a Basis for QbD/PAT Implementation in Mammalian Cell Culture Bioprocesses?
Moderator: Gerald Striedner, Ph.D., Associate Professor, Biotechnology (BOKU), Principal Investigator, Austrian Center of Industrial Biotechnology (ACIB)

  • Advanced on- and offline monitoring strategies
  • Implementation of hybrid modeling approaches in mAB production processes
  • Transferability of hybrid models along scales from shaker to laboratory and pilot scale
  • Towards Model predictive control (MPC) in bioprocesses

Regulatory Requirements for HCPs

Moderators: Erika Friedl, Quality Expert, Haematology and Transfusion Medicine, Paul-Ehrlich Institute

Ruth Paul, Independent Consultant

  • HCP regulatory expectations throughout development
  • Common pitfalls made by companies
  • European vs. US expectations

 

Best Practices for Host Cell Protein Analysis Using Mass Spectrometry

Ying Zhang, Senior Scientist, Analytical Research & Development, Pfizer

  • Choice of Instrumentation
  • System Suitability and Performance Validation
  • Best Practice for Quantitation
  • Next Gen HCP Analysis

 

Biologics Formulation and Stability

Moderator: Haresh T. More, Ph.D., Research Investigator I, Parenteral Science and Technology, Bristol-Myers Squibb

  • Current Formulation development in biologics, protein and peptides
  • High Concentration Protein Formulation
  • High Throughput methods, new technologies in protein biophysical assessment

 

Management of DP Temperature Excursions during Shipping and in Clinic

Moderator: Tatiana Nanda, Ph.D., Biopharm Product Development Investigator, Biopharm Product Sciences, GlaxoSmithKline

  • Ways to allocate the allowable temperature excursion perids
  • Ways for self-management of temperature excursions in clinic

Use of a Platform Formulation Versus Innovative Formulation Approaches for Accelerated Development

Moderator: Radhakrishna Maroju, Ph.D., Senior Scientist, Biologics CMC, Teva Biopharmaceuticals USA

  • Risk-based analysis in the decision process.
  • Unique formulation challenges for novel biologic modalities
  • QbD applications in development of drug products – formulation to container closure selection

New Tools for Characterization of Protein Aggregation and Stability

Moderator: Sanket Patke, Ph.D., Research Investigator, Drug Product Science and Technology, Pharmaceutical Development, Bristol-Myers Squibb

  • Novel high-throughput tools
  • Strategies to detect and manage chemical degradation
  • PAT for in process/ in line detection

 

Regulator Expectations for Cell and Gene Therapies

Moderators: Matthias Renner, Ph.D., Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute

Bernadette Keane, Ph.D., Principal, Keane Consultancy

  • Cell therapy regulatory expectations throughout development
  • Common pitfalls
  • CMC Strategies for Expedited pathways
  • European vs. US expectations

 

The Role of CQAs, In-Line Measurements, Flexible Automation and Standards

Moderator: Krishnendu Roy, Ph.D., The Robert A. Milton Chair and Professor, Biomedical Engineering; Director, Marcus Center for Cell Therapy Characterization Manufacturing (MC3M), Georgia Tech

  • Setting CQAs
  • Process analytics in cell therapy development
  • Flexible Adaptive Automation
  • Analytical Strategies

Benefits And Risks of Using Metagenomics In a Quality Environment

Moderator: Edward Mee, Ph.D., Senior Scientist, Live Viral Vaccines, Virology, National Institute for Biological Standards and Control

  • Potential to improve testing sensitivity and/or reduce reliance on in vivo tests
  • Incidental findings of unknown relevance
  • Finding the signal in an ocean of noise

New Trends in Viral Clearance

Moderator: David Cetlin, Founder & CEO, MockV Solutions LLC

  • Technologies
  • Regulatory Thoughts,
  • End-user Value
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