Providing proof that no replication-competent lentivirus (RCLs) is present in a gene therapy product is essential for authorizing its clinical use, yet it is often overlooked and could lead to dramatic consequences, significantly delaying the clinical development of the product and its commercialization.
In the present paper, the challenges related to the RCL testing will be addressed. Solutions and a strategic roadmap will be proposed to help
scientists, investigators, regulatory affairs professionals and CDMOs to build RCL testing strategy with a focus on the key points to consider
progressing serenely towards a Good Manufacturing Practice (GMP) transition and phase-appropriate testing.
