The San Sebastián, Spain based contract development and manufacturing organization (CDMO), which develops and manufactures lentiviral vectors, says its Good Manufacturing Practice (GMP)-accredited new facility is now fully operational after receiving the renewal of its GMP accreditation for a further three years.
“As the cell and gene therapy industry continues to grow, we are seeing an exponential increase in the demand for lentiviral vectors. Our facility now being fully operational puts us in the best position to support our customers, from those in early-stage clinical development up to commercialization,” said Gurutz Linazasoro, CEO, VIVEbiotech. “VIVEbiotech is one of the few companies to be solely focused on the manufacture and development of lentiviral vectors. Furthermore, our expertise in virology allows us to support our customers throughout the development cycle, maximizing production and thus guaranteeing success in more advanced phases.”
Founded in 2015, the CDMO’s technology development strategy is focused on providing a response to the main hurdles that currently exist within the gene therapy field, mainly the need of cost-effective processes.
Workforce increased by over 50%
Through expansion of its production capabilities and workforce, VIVEbiotech said it will be able to meet the industry’s rising demand for viral vectors.
The organization says it has increased the number of manufacturing slots available to produce lentiviral vectors, to support customers throughout the development cycle, while it added that it has also managed to more than double the number of its employees in the past two years.
Natalia Elizalde, business development director, VIVEbiotech, told us about the initiatives the CDMO has in place in relation to recruitment:
"We have collaboration agreements both with nearby universities and Vocational Training Centers so that students are assigned to VIVEbiotech every year routinely. This is so they can proceed with a very well-defined training program aimed at our activity in lentiviral vector manufacturing.
"Additionally, our region, the Basque Country in northern Spain, is becoming a well-known gene therapy hub, which makes the recruitment process more straightforward."
The company has also enhanced its internal training programs, she said.
Additionally, it has incorporated an automated fill/finish system into its processes, which, it outlined, removes several costly and labor intensive tasks from the manufacturing process.
The company also reported that its new GMP accreditation has a greater scope than its previous one - it is now GMP certified for in-vivo applications in addition to ex-vivo.
"We are GMP-certified to manufacture lentiviral vectors to be used both as intermediate as well as final product. This means we can assure our process is appropriate and safe both for ex-vivo and in-vivo applications in terms of regulation. Indeed, we are currently manufacturing four lentiviral vectors to be used in in-vivo applications," added Elizalde.
The US is the CDMO’s main market, representing 70% of its client base, with European and Asian players accounting for the remaining 30%.