Long-term stability of clinical-grade lentiviral vectors for cell therapy.

ABSTRACT: The use of lentiviral vectors in cell and gene therapy is steadily increasing, both in commercial and investigational therapies. Although existing data increasingly support the usefulness and safety of clinical-grade lentiviral vectors used in cell manufacturing, comprehensive studies specifically addressing their long-term stability are currently lacking. This is significant considering the high cost of producing and testing GMP-grade vectors, the limited number of production facilities, and lengthy queue for production slots. Therefore, an extended shelf life is a critical attribute to justify the investment in large vector lots for investigational cell therapies. This study offers a thorough examination of essential stability attributes, including vector titer, transduction efficiency,

SUBMITTER: Jadlowsky JK 

PROVIDER: S-EPMC10811425 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature