'Dramatic' Gene Therapy Demand Drives Viral Vector Delays

Some gene therapy developers are waiting more than a year for viral vectors due to the shortage in third-party services, says European CDMO Yposkesi.

French contract development and manufacturing organization (CDMO) Yposkesi claims to have the largest industrial platform for the GMP manufacture of viral vectors for gene therapies in Europe. The firm has four independent production suites and two fill & finish suites, with current capacity of 35 batches per year.

And now the manufacturer is set to grow further after the Board approved a 5,000 m² facility expansion comprising of two independent suites equipped with 1,000 L single-use bioreactors.

“The building of our commercial facility was approved in April 2018 by our Board. The work is planned to start before end of the year and is commissioned for Q3 2021,” CEO Alain Lamproye told BioProcess Insider. “We believe that it is important to provide our clients with a full service offering to include process development and the uninterrupted supply of clinical and commercial batches.”

The expansion is a necessary response to the high demand for viral vector supply, he said, stoked by a lack of third-party capacity.

“Currently the request from gene therapy companies for viral vectors manufacturing is higher than the current global capacity of the CMOs. Companies developing gene therapy products appear to have to wait more than a year before their viral vectors can be manufactured.”

Clinical and Commercial Growth

Demand has grown on the back of recent approvals, including Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec-rzyl) and two chimeric antigen receptor (CAR) T cell therapies – which incorporate lentiviral vectors – last year.

“Since the approval to market of three gene therapy products in 2017, the demand for viral vectors has dramatically increased,” Lamproye said. “A large number of biotechs and pharmaceutical companies have entered clinical phases and VCs are increasingly investing in gene therapy companies.”

Lamproye, who joined Yposkesi in January 2017 after heading up the Biopharma Business Unit at Novasep, said there are currently more than 600 trials ongoing incorporating gene therapies.

His comments mirror those made by end-users in KNect365 Life Sciences’ recent Cell and Gene Therapy Survey.

However, like Yposkesi, the outsourcing industry is looking to plug the supply-demand gap and over the past year, there has been a spate of investment in the cell and gene therapy space. Examples include Lonza, Brammer Bio, VGXI, Fujifilm, and Paragon Bioservices.

Manufacturing Equipment

It is not just manufacturing services which are under short supply in the surge of gene therapy demand.

BioProcess Insider recently reported some gene therapy makers are waiting as long as six months for multilayer, scalable, and single-use culture vessels, commonly known as hyperstacks.

These vessels are used to produce viral vectors and gene therapies, and are in huge demand for similar reasons as highlighted above.