VIVEbiotech has expanded its in vivo lentiviral vector portfolio to 15 therapeutic programmes as demand grows for manufacturing technologies that support next-generation cell and gene therapies.

The contract development and manufacturing organisation said the programmes span applications including in vivo CAR-T therapies, rare diseases, gene editing and vaccines. Several have already received regulatory clearance to enter clinical trials, including from FDA.

Interest in in vivo approaches has increased because they could simplify treatment delivery compared with ex vivo methods, although direct administration places greater demands on manufacturing quality, purity and analytical testing.

VIVEbiotech said it is among a limited number of CDMOs able to release GMP-grade lentiviral vectors as final products for direct patient administration, positioning the company to support developers working in the emerging field.

Chief executive Jon Alberdi said manufacturing standards become increasingly important as therapies move from laboratory development towards clinical use.

Alberdi said: “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. Our expertise allows us to meet these demands and support innovators pushing the boundaries of gene therapy.”

The company said its manufacturing platform has been designed to maintain vector integrity while improving yields and reducing production costs through process intensification and optimised transfection conditions. It also highlighted downstream processing designed to improve purity and remove process-related impurities while maintaining vector infectivity.

According to VIVEbiotech, recent process improvements have reduced residual DNA levels and strengthened the safety profile of its lentiviral vectors, an important consideration for therapies administered directly to patients.

The company has also developed analytical methods tailored specifically to in vivo lentiviral vectors, including potency assays and testing approaches informed by regulatory feedback for direct administration programmes.

Marie Fertin, chief custom solution and process development officer, said the sector is undergoing significant change as developers increasingly explore in vivo delivery strategies.

Fertin said: “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. 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.”

VIVEbiotech currently operates more than 3,000 square metres of GMP manufacturing space across seven cleanrooms and said it continues to invest in expanding production capacity. The company expects an ongoing expansion programme to increase manufacturing capabilities by 2028 as demand for in vivo therapies grows.

Its platform supports multiple lentiviral vector configurations and pseudotypes for applications ranging from CAR-T therapies and vaccines to rare disease programmes. The company said it combines scalability with manufacturing flexibility to support partners throughout development and commercialisation.

The expansion of its manufacturing capabilities follows investment secured from Ampersand Capital Partners in late 2024, which was intended to strengthen large-scale and commercial production capacity for advanced therapy programmes.