Comparability studies can be the biggest challenge in developing a cell or gene therapy product, but they are essential to maintain your product’s critical quality attributes (CQA). When the smallest changes to processes or analytical methods can derail a product’s approval, it’s essential to make sure you’ve covered every detail.   

Scott R. Burger, MD, the principal of Advanced Cell & Gene Therapy, and William E. Janssen, PhD, the principal of WEJ Cell and Gene Therapy Consulting Services, will explain exactly what you need to know about comparability so you can meet all requirements and obtain approvals. 

Webinar Takeaways:

  • FDA requirements for comparability studies for gene and cell therapy products 

  • Best practices for risk analysis and mitigation using comparability studies 

  • How to design an effective comparability protocol for a gene or cell therapy product 

  • How to construct a statistical approach to comparability 

  • How to assemble the comparability package to comply with FDA requirements 

Understanding — and meeting — comparability requirements is crucial to developing gene and cell therapy products. This is your opportunity to ensure yours comply. Join us by registering now. 

Who Will Benefit:

  • Quality professionals 

  • Regulatory affairs professionals

  • Manufacturing process development professionals 

  • Analytics professionals 

  • Research and development personnel 

  • Senior management at cell and gene therapy (pharma/biotech) companies