Description:

Cell and gene therapy (CGT) research is both dynamic and promising. Cell therapies have the potential to treat various disease states, including cancer, liver diseases, primary immunodeficiency diseases, etc. This paper focuses on cell therapies and those differences associated with CGT versus classical biopharma production as it pertains to the topic of extractables and leachables (E&L). It should be noted that, although viral-vector manufacturing (VVM) can be considered part of CGT, this will not be discussed largely as VVM requires several downstream steps, which makes it more similar to classical biopharma production.