The CDMO VIVEbiotech has added its 15th in vivo lentiviral vector-based therapeutic programme to its roster.
The company's programmes — several of which have already received regulatory clearance for clinical trials — span a wide range of applications, including in vivo CAR-T, rare diseases, gene editing and vaccines.
VIVEbiotech cited growing interest in in vivo approaches, given their potential to address some of the manufacturing and commercialisation challenges associated with current ex vivo methods, as a driver of significant investment in the technology.
However, it noted that direct administration of lentiviral vectors requires stricter quality standards for the final product. Thus, optimising process control is essential for improving yield and purity, especially as manufacturing complexity increases and the need for thorough analytical characterisation grows.
"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," added 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.
The company already supports large-scale manufacturing of in vivo programmes, leveraging its extensive bioreactor capacity, more than 3000 sqm of GMP facilities and seven cleanrooms.
An ongoing expansion plan will further increase manufacturing capacity by 2028, supporting the growing demand for in vivo therapies.
The expansion of VIVEbiotech's capabilities has been further enhanced by a growth investment from Ampersand Capital Partners, secured in December 2024, to bolster large-scale and commercial manufacturing capacity.