- VIVEbiotech has expanded its in vivo lentiviral vector portfolio to 15 therapeutic programs, covering applications including in vivo CAR-T, rare diseases, gene editing, and vaccines.
- The CDMO highlighted its manufacturing, analytical, and GMP capabilities designed to support the development and large-scale production of in vivo cell and gene therapies.
VIVEbiotech announced that it has added its 15th in vivo lentiviral vector-based therapeutic program, further expanding its portfolio of in vivo cell and gene therapy projects. According to the company, several of these programs have already received regulatory clearance for clinical trials, including approvals from the U.S. Food and Drug Administration (FDA). The programs span multiple applications, including in vivo CAR-T therapies, rare disease treatments, gene editing, and vaccines.
The company said growing interest in in vivo cell and gene therapies is driving investment due to their potential to address manufacturing and commercialization challenges associated with ex vivo approaches. VIVEbiotech noted that direct administration of lentiviral vectors requires more stringent quality standards, placing greater emphasis on process control, product purity, and analytical characterization throughout development and manufacturing.
As a lentiviral vector CDMO, VIVEbiotech has developed a manufacturing platform designed to support large-scale production of in vivo therapies. The company stated that its platform combines upstream process intensification, optimized transfection conditions, and downstream purification technologies to improve yields, maintain vector functionality, and achieve high purity levels. Recent process optimizations have also reduced residual DNA levels to support product safety requirements.
“In vivo lentiviral vectors have the potential to transform treatment paradigms through faster administration and direct therapeutic delivery. However, these advantages come with more stringent manufacturing requirements — from achieving the required purity profile to ensuring consistent performance at scale.”
Jon Alberdi, CEO of VIVEbiotech
VIVEbiotech said it currently operates more than 3,000 square meters of GMP manufacturing space across seven cleanrooms and supports large-scale lentiviral vector production using high-capacity bioreactors. The company added that an expansion program scheduled through 2028 will further increase manufacturing capacity to support growing demand for in vivo gene therapies. The expansion follows a growth investment from Ampersand Capital Partners announced in December 2024.
