VIVEbiotech, a leading lentiviral vector Contract Development and Manufacturing Organization (CDMO), underscored its industry leadership in the development and manufacturing of in vivo cell and gene therapy (CGT) vectors with 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.”
Platform excels for in vivo
VIVEbiotech’s platform has been specifically designed to preserve lentiviral vector integrity throughout the manufacturing process by minimizing shear stress and maintaining cell health, thereby ensuring high vector functionality. By integrating process intensification strategies with optimized transfection conditions, reduced reagent usage, and improved productivity, the upstream setup contributes to enhanced yields and a significant reduction in cost of goods.
By including a state-of-the-art downstream process, the platform achieves high functional performance alongside industry-leading purity levels. This approach enables strong recovery of functional titers and efficient removal of process-related impurities, maintaining vector infectivity from harvest to final product.
In terms of purity, VIVEbiotech’s platform meets the high standards required for in vivo use. Recent optimizations have achieved logarithmic reductions in residual DNA levels, further strengthening the safety profile of its lentiviral vectors. This balance between performance, purity, and scalability is particularly critical for in vivo applications, where both functional quality and manufacturing efficiency are key to clinical and commercial success.
Beyond manufacturing, VIVEbiotech has developed a fully customized analytical framework tailored to in vivo lentiviral vectors. Its dedicated analytical development team specializes in advanced vector characterization, including potency assay development and a full testing panel is proposed following regulatory feedback received for direct in vivo administration. All raw materials, including critical components such as plasmids, are sourced and qualified according to the highest quality standards.
The company also supports large-scale manufacturing of in vivo programs, leveraging some of the largest bioreactor capacities available for lentiviral vector production. With more than 3,000 sqm of GMP facilities and seven cleanrooms, VIVEbiotech ensures timely delivery across development stages. An ongoing expansion plan will further increase manufacturing capacity by 2028, supporting the growing demand for in vivo therapies.
VIVEbiotech’s lentiviral vector platform, optimized for in vivo applications, supports a broad range of applications, including CAR-T therapies, vaccines, and rare disease programs, and offers extensive flexibility through multiple pseudotypes, production approaches, and vector configurations. The platform consistently delivers high quality lentiviral vectors with strong performance and competitive cost of goods, positioning partners for success across the development lifecycle.
The expansion of VIVEbiotech’s capabilities has been further supported by a growth investment from Ampersand Capital Partners, secured in December 2024, aimed at strengthening large-scale and commercial manufacturing capacities.
