CDMO quadruples lentiviral capacity on the back of cell gene demand

VIVEbiotech has responded to the high demand for lentiviral vectors in the cell and gene therapy space by expanding its facilities.

While no financial details have been disclosed, the Spanish contract development manufacturing organization (CDMO) said it is ramping up its manufacturing capacity and processes enabling it to respond to lentiviral demand.

“We are based in San Sebastian in northern Spain, very close to the French border,” a spokesperson told BioProcess Insider. “Our facilities will be increased in around 3,000 m2 [with] all this space dedicated to increasing our manufacturing capabilities.”

Image/iStock: oatawa

In addition, the expansion will enable the firm to invest in further manufacturing equipment and capital, preparing it for current and future phases of projects.

According to VIVEbiotech, the versatility in its design results in flexible configuration meaning there is potential for further cleaning rooms with future development and the possibility to accommodate a larger number of batches.

“On average, we manufactured around 20 batches in 2020. The batches expected for 2021 are 40, and this number will be doubled to 80 in 2022 reaching commercial-scale manufacturing,” a spokesperson told us.

The new facilities are expected to be operational by April 2021 and the firm intends for the transition between facilities to be completed in October. According to the firm, it expects “the headcount to increase [by] 30% in the coming two years.”

Following its completion, VIVEbiotech aims to cater for an international market offering further advanced optimization of lentiviral vector properties and manufacturing processes.

Cell and gene therapies and lentiviral demand

The firm says the expansion is “required” due to the global gene and cell therapy sectors moving quickly into a wider spread of indications that impact “more patients and use more innovative applications.”

According to VIVEbiotech it “will have the biggest bioreactor sizes available in the market that are suitable for commercial scale manufacturing,” adding “we have made significant investment in developmental equipment both to increase the quality and quantity of our lentiviral vectors in order to increase their final functionality.”

Lentiviral vectors are being used in cell and gene therapies as they are devoid of viral proteins, free from replication competent virus, and able to transduce non-dividing cells.

Many cell and gene therapy companies are using lentiviral vectors in their prospective therapies. Examples include Bluebird Bio’s sickle cell gene therapy LentiGlobin, Mustang Bio’s bubble boy candidate MB-107, and Orchard Therapeutics, which last year received approval for its lentiviral-based therapy Libmeldy.