Achieving Best Practice in Quality Control and Assurance
Changing the Cell Therapy Landscape with In-Vivo Therapies: Is this a Viable Alternative for Point of Care Therapeutics?
Implementing New and Enabling Technologies into Existing Processes for Improved Commercial Outcomes
Implementing New and Enabling Technologies into Existing Processes for Improved Commercial Outcomes
Analytics, Data and IT Tech Solutions: An Overview of Best Practices and Technology
Delivery Solutions, Improvements and Alternatives for Gene & Cell Therapy
Industry 4.0 Approaches Transforming Cell and Gene Therapy
Accelerating the Digitalisation Revolution in Cell and Gene Therapy Development
Viral Vector Development: Safe and Effective Viral Vectors for Therapeutic Success

Achieving Best Practice in Quality Control and Assurance

28 Jan 2022

11:00 Chairperson’s Opening
Richard McFarland, Chief Regulatory Officer, ARMI

11:05 Building Robust Quality Systems in a Cell Therapy Company

This presentation will provide an overview of our experience building and evolving quality management systems in an early-stage cell therapy company, including:

  • Transitioning from discovery science to manufacturing for clinical programs
  • Building a quality organization from scratch
  • Developing risk-based, scientifically-informed quality systems

Emily English, Director of Quality, Cartesian Therapeutics

11:20 Accellix Implementation for Cell Therapy Manufacturing

  • Describe the testing burden with cell analysis in cell therapy manufacturing and challenges
  • How the technical feasibility for the Accellix platform was assessed to implement the technology in the GMP environment
  • Showcase data from Accellix T Cell Subset assay and algorithm-based automated data analysis

Rhessa Diaz, Senior Manager of Cell Therapy Analysis, Bristol Myer Squibb

11:35 One-Hour Testing For Mycoplasma Contamination In C&GT Samples Using The Biofire® Filmarray® 2.0 Industry System

  • The BIOFIRE® FILMARRAY® 2.0 Industry system provides 1 hour detection of mycoplasma contamination with less than 2 minutes of hands-on time
  • Internal validation data indicate suitable specificity and limit of detection to be used as both an in-process control and release test
  • Evaluations performed by bioproduction and Cell and gene therapy manufacturers confirm suitability of the BIOFIRE FILMARRAY 2.0 Industry system in the presence of high density monoclonal antibody producing Chinese hamster ovary (CHO) cells or human cells as a rapid mycoplasma test for in-process control or release at harvest

Félix Montero-Julian, Scientific Director, bioMérieux

11:50 CMC Progression from Early to Late Phase, Practical Considerations

The principles for developing traditional biologics do not always translate well to cell and gene therapy products.  Creative yet practical adaptations are necessary to advance gene therapy programs toward licensure.  Key areas where practical adaptations are required:

  • Change control and managing product evolution for non-traditional development pathways, comparability challenges
  • Maturation of analytics – the expected level of product understanding, method advancement from early to late phase, evolving regulatory expectations

Sarah Thomas, Vice President of Quality, REGENXBIO

12:05 Panel Discussion & Speaker Q&A


Richard McFarland
Chief Regulatory Officer
Emily English
Director of Quality
Cartesian Therapeutics
Rhessa Diaz
Senior Manager of Cell Therapy Analysis
Bristol Myer Squibb
Sarah Thomas
Vice President of Quality