SK pharmteco, SK Inc.’s contract development manufacturing organization (CDMO) for pharmaceuticals, completed its second facility for cell and gene therapies (CGT) manufacturing in Europe. With this milestone, SK pharmteco is rapidly expanding its presence in the global market.

SK pharmteco announced on June 22nd that Yposkesi, its commercial viral vector manufacturing subsidiary for CGTs in France, successfully completed the construction of its second industrial bioproduction site for CGT manufacturing.

Yposkesi’s second bioproduction site is situated in its Genopole campus, the largest biotech cluster in France. The newly completed site is a 5,000 square meter facility designed in accordance with current Good Manufacturing Practices (GMP) guidelines of the U.S. and Europe. Together with the first bioproduction site, which is also located in the Genopole campus, Yposkesi now boasts one of Europe’s largest biomanufacturing facility for CGT that spans 10,000 square meters.

The new site specializes in the bioproduction of adeno-associated virus (AAV) and lentiviral vector (LV)—the widely used viral vectors in the field of cell and gene therapies, spanning from clinical to commercial applications.

With commitments from multiple clients already secured for the second facility, the company is preparing for mass production in 2024. According to the global research firm MarketsandMarkets, the global viral vector market, estimated at $5.5 billion in 2023 and forecast to reach $12.8 billion by 2028, is projected to increase by a compound annual growth rate (CAGR) of approximately 18%.

Yposkesi is poised to enhance its global presence due to the increasing demand for viral vectors and few cGMP-compliant facilities for large-scale production.

Furthermore, Yposkesi is expanding its presence in the anti-cancer and immune cell therapy market with the introduction of 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.

Lentivirus, a prominent viral vector utilized in gene therapy and cell-based immune anticancer drugs, has experienced a surge in demand, driven by the expanding CAR-T cell therapy* market. Yposkesi, leveraging its high-yield cell culture/harvesting capabilities and cost competitiveness, has successfully ensured exceptional quality and time to market delivery of Lentiviral Vectors.

“It is with great pleasure and pride that today we open the new Yposkesi viral vector manufacturing facility,” said Alain Lamproye, CEO of Yposkesi. “This twin site enables us to stay up to pace with demand by producing larger quantities of CGT 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 CGT pipelines and commitments, making these treatments more accessible to patients.”

“We anticipate Yposkesi to become a leading global cell and gene therapy CDMO through the synergy achieved with the Center for Breakthrough Medicines (CBM), a US-based cell and gene therapy CDMO and a subsidiary of SK pharmteco,” said Yeontae Kim, head of the Bio Investment Center at SK Inc.

www.yposkesi.com
www.skpharmteco.com