A survey was used to gather initial data to benchmark member company experience with replication competent AAV testing (Dec 2021). Members working with in vivo gene therapies using AAV were invited to complete the survey. Members were asked:
- What are the typical titers of your AAV vector(s)?
- What are the typical dose ranges of your AAV in vivo gene therapy(s)?
- How much material do you allocate for rcAAV testing?
- In your organization, typically what level of rcAAV do you see in Drug Product(s) and how is this expressed (units)?
- Since there is no defined acceptable criteria for rcAAV in current FDA guidance, does your organization set an acceptable limit on rcAAV in DP?
- Has it been possible to release a drug product in your organization if rcAAV is above LOD?
- What cell lines does your organization use for rcAAV assay?
- At what phase of product development is rcAAV generally investigated within your organization?
Results from this survey are intended to stimulate further discussion of this topic within the workstream.