Yposkesi inaugurates €60M biomanufacturing site for cell and gene therapies

Additional 5,000 m² site expansion doubles Yposkesi’s viral vector production capacity; clients can more easily scale-up cell and gene products from clinical to commercial batches

Evry-Courcouronnes (near Paris), France, June 22, 2023 – Yposkesi, SK pharmteco’s clinical and commercial viral vector manufacturing subsidiary for Cell and Gene Therapies (C&GT), today announces the inauguration of its new 5,000 m² (50,000 ft²) industrial bioproduction site for C&GT manufacturing, its second facility. This €60M ($65.3M) expansion, which doubles Yposkesi’s cGMP manufacturing footprint to 10,000 m² (100,000 ft²), supports the biopharma industry’s need to address shortfalls in the supply of viral vectors, the preferred gene delivery system used to manufacture C&GT products.

Viral vectors are key enablers in manufacturing C&GT products, the most advanced personalized forms of medicine for treating critical diseases and rare disorders.

By doubling its production capacity up to 75 batches per year, Yposkesi is providing clients with significantly improved year-round access to higher yields of high-quality viral vectors for their C&GT projects, from early drug development to large-scale commercial manufacturing.

Yposkesi CEO, Alain Lamproye, CEO of SK pharmteco, Joerg Ahlgrimm, and Yeontae Kim, EVP head of the Biotech Investment Center at SK Inc. presided over the ribbon cutting ceremony attended by clients, French government officials and employees.

“It is with great pleasure and pride that today we open the new Yposkesi viral vector manufacturing facility,” said Lamproye. “This twin site enables us to stay up to pace with demand by producing larger quantities of C&GT products approved for commercialization. The facility’s state-of-the-art design will allow us, in collaboration with our clients, to manufacture advanced therapies more efficiently and cost-effectively in line with their C&GT pipelines and commitments, making these treatments more accessible to patients.”

Yposkesi’s twin viral vector manufacturing sites are located next to each other on the Genopole campus, the largest biotech cluster in France.

This multi-product facility’s added capacity enables Yposkesi to manufacture products in parallel and to stagger batch starts to optimize its use. The twin facility reinforces Yposkesi’s business continuity plan with back-up production and quality control capabilities to safeguard delivery guarantees for clients. It is compliant with both European and American current GMP guidelines.

Better access to viral vector manufacturing, to accelerate time to market for cell and gene therapies and hence better patient outcomes, was the driver for this €60M ($65.3M) investment.

The growing global viral vector manufacturing market, estimated at $5.5bn in 2023 and forecast to reach $12.8bn by 2028, increasing at a CAGR of 18.2%, and market drivers, including the rising prevalence of target diseases and disorders, the availability of drug development funding and the effectiveness of viral vectors in gene delivery, also factored into the decision to extend Yposkesi’s production capacity.

The new site, currently undergoing qualification, is scheduled to be fully operational in 2024. It will create roughly 90 new jobs.

The site is equipped to run both AAV and LV platforms, notably Lentisure™, a CAR T-cell platform designed to optimize higher yields. The facility is designed with six USP (Upstream Process) and two DSP (Downstream Process) clean rooms. This more than triples Yposkesi’s bioreactor capacity from 2,000 L to 7,000 L and reduces the turnaround on projects from 18- to 12-months. It has fill and finish capacities with semi-automated suites for a total of 12,000 vials per year.

In line with SK pharmteco’s ESG initiatives, Yposkesi contracted CBI, a subsidiary of Vinci Construction France, as general contractor. Pharmaplan, an engineering service for the pharmaceutical industry, assisted on the building’s design. Incorporating green solutions into the design and construction was of key importance. These included:

• Appropriate management of installations and reduction of losses to minimize energy consumption during construction
• Use of renewable energies such as solar panels to heat water and charging stations for electric vehicles
• Selection of more energy-efficient equipment, especially for manufacturing processes and production systems
• Energy recovery to reduce the carbon footprint

Yposkesi is among only a small group of global CDMOs with decades of bioprocessing experience and expertise. It is one of the few in Europe to operate two bioproduction platforms for the most used viral vectors: Adeno Associated Virus (AAV) and Lentiviral Vector (LV). It has more experience than most players at producing viral vectors at an industrial scale.