Lentiviral Vector
Lentiviral Vector refers to a gene delivery system derived from lentiviruses, engineered to safely introduce genetic material into target cells while removing pathogenic replication capability. Lentiviral vectors are capable of transducing both dividing and non-dividing cells, enabling stable gene integration and long-term expression. This makes them particularly valuable in ex vivo gene therapy and cell therapy manufacturing, where durable modification of patient-derived cells is required.
The biopharmaceutical industry relies on lentiviral vectors as a core enabling technology for CAR-T cell therapies and other genetically engineered cell products. Manufacturing involves stringent quality control testing for vector titre, purity, residual host cell DNA, replication-competent lentivirus, and genetic integrity. Regulatory scrutiny is high due to insertional mutagenesis risks, requiring comprehensive safety evaluation and long-term patient monitoring in clinical trials. Scale-up challenges include maintaining consistent yield, ensuring batch reproducibility, and securing sufficient manufacturing capacity as clinical demand rises. As advanced therapies expand globally, lentiviral vector innovation continues through improved production platforms, safer designs, and more efficient transduction processes.
