VIVEbiotech announced the addition of its 15th in vivo lentiviral vector-based therapeutic program using its well-established platform. These programs, several of which have already received regulatory clearance for clinical trials, including from the FDA, span a wide range of applications such as in vivo CAR T, rare diseases, gene editing, and vaccines.
Growing interest in in vivo cell and gene therapies is driving significant investment, given their potential to address some of the manufacturing and commercialization challenges associated with current ex vivo approaches. However, the direct administration of lentiviral vectors imposes significantly more stringent requirements on the quality attributes of the final product. Accordingly, process control must be optimized to improve both yield and purity. As manufacturing becomes increasingly complex, the scope of analytical characterization is also expanding.
VIVEbiotech has built a differentiated position in this field by combining deep expertise in lentiviral vector development with a platform specifically designed to deliver high-quality lentiviral vectors while overcoming the challenges of large-scale manufacturing for in vivo applications. The company is among the few CDMOs globally authorized to release GMP-grade lentiviral vectors as final products, a key milestone for therapies requiring direct patient administration.
In vivo lentiviral vectors have the potential to transform treatment paradigms through faster administration and direct therapeutic delivery,” said Jon Alberdi, CEO of VIVEbiotech. “However, these advantages come with more stringent manufacturing requirements — from achieving the required purity profile to ensuring consistent performance at scale. Our expertise allows us to meet these demands and support innovators pushing the boundaries of gene therapy."
“As interest in in vivo delivery continues to grow, we are witnessing a fundamental shift in how gene therapies are developed and brought to patients,” said Marie Fertin, Chief Custom Solution & Process Development Officer of VIVEbiotech. “Our continued investment in capabilities reflects both our confidence in this field and our commitment to enabling our partners to succeed in increasingly complex manufacturing environments.”