When developing processes, it is important to start with the end in mind, which is the successful manufacture of the product of interest. To do this, a key focus from the start must be your analytical strategy. Analytical development can take a significant amount of time, expertise and assays, particularly within the Cell and Gene Therapy (CGT) sector, are often initially crude and imprecise, so building an Analytical development strategy into your high-level CMC plan from the get-go is crucial.
This webinar will explore how to take an assay from a Critical Quality Attribute (CQA) to a validated method highlighting necessary areas of focus, challenges and lessons learnt. A case study will also be presented to illustrate real world examples of challenges faced and obstacles overcome in the journey to success. The webinar will focus on both Cell and Gene Therapies.
Key Learning Objectives
- How to build an analytical strategy.
- How to transition from CQA to having a validated method ready for transfer to QC.
- How to set up for success and an illustration of the lessons learned when developing a qPCR/ddPCR assay for AAV and a Flow Cytometry method for a Cell Therapy product.
