SK pharmteco's contract development manufacturing organization (CDMO) for pharmaceuticals, successfully completed its second facility for Cell and Gene Therapies (C>) manufacturing in Europe.
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SK pharmteco announced that Yposkesi, its commercial viral vector manufacturing subsidiary for C> in France, successfully completed the construction of its second industrial bioproduction site for C> 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 m2 facility designed in accordance with current Good Manufacturing Practices (GMP) guidelines of the US 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 C> that spans 10,000 m2.
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.
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.
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 (KRW 7.5 trillion) in 2023 and forecast to reach $12.8 billion (KRW 16.5 trillion) 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 rapidly 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.
In 2022, SK pharmteco became the second largest shareholder of the Center for Breakthrough Medicines, a leading cell and gene therapy CDMO in the United States, thereby securing state of the art production facilities for cell and gene therapy in both Europe and the United States. ■