Demand for lentiviral vectors will continue to outstrip supply until the industry has access to more efficient, purpose-built manufacturing and bioprocessing technologies.
The warning comes from Natalia Elizalde, PhD, chief business development officer at Spanish contract manufacturer and vector supplier VIVEbiotech, who told GEN that demand for lentiviral vectors has increased as new therapeutic modalities have emerged.
“The applications of lentiviral vectors are diverse,” she says, pointing out that while 65% of the CDMO’s customers are developing immunotherapies, like CAR-Ts, TCRs, NK-CARs, NK-TCRs, TILs, some 15% are targeting rare diseases with another 10% working on vaccines.
The demand surge also reflects the maturity of lentiviral vector technology, according to Elizalde, who adds: “This technology is based on a pre-existing system, which has been in use for many years and therefore is a very well optimized mechanism.
“Approved successful products are being administered using this delivery method to an increasing number of patients. Moreover, a great number of clinical trials demonstrating the safety and efficacy of lentiviral vectors are ongoing.”
Increased industry demand is a commercial opportunity for CDMOs. However, producing lentiviral vectors at a scale sufficient to meet this demand is not without challenges.
Complex process
Elizalde says, “The manufacture of lentiviral vectors is a complex process…The biggest challenges are linked to the intrinsic characteristics of the vectors—they are very sensitive to shear forces and physicochemical parameters, for example.
“That is why it is so key that every single manufacturing step—everything from transfection, transient transfection, and TFF—is well adapted and considers both productivity and purity as key factors to be preserved all along the process while guaranteeing scalability,” she continues.
Chromatography is particularly challenging with current technologies, according to Elizalde, who adds that while available methods are adequate, there is room for improvement.
“One area that could improve is chromatography. At present, chromatography systems achieve between 30–40% recovery when used in vector production. However, we think a more specific step designed for lentiviral vectors—rather than classical anion exchange chromatography—would be beneficial for the field as it would boost productivity and therefore cost-effectiveness.”
VIVEbiotech is also working to incorporate other innovative technologies into its vector production operations, Elizalde says.
“[Artificial intelligence] (AI) and automation have a role and for VIVEbiotech it is a strategic and multidisciplinary project to incorporate both automation and AI within our processes. This will be beneficial to model and control production which will enhance the reproducibility and predictability of processes.”
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