Panel discussion: potency assays for comparability, characterisation and release
11 Sep 2018
- What type of release assays are adequate for a regulator to approve the product in both cell and gene therapies?
- How do regulators define quality in release assays and how can the industry use this as a guide for regulatory approval?
- How do regulators validate assays? What kind of assays can actually be validated?
- Viral vectors and gene modified cell products: are these release assays really necessary? Do you need one for your starting material and one for your end product?
- Advice on extractables and leachables - what is the regulatory guidance on determining the purity of the final product? Which tests have worked well for products that have made it to market?
- Different regulations for EU and US- can we harmonise on the quality aspect of release testing?
- How do you predict if a batch will be successful at a clinical level?
- Consistency: How do you define your critical quality attributes and assays so you know each batch is the same?
Have your say: panel discussion to be opened up to the audience for input after each discussion point