French contract manufacturer Yposkesi, which specializes in cell and gene therapies, has begun construction on the company’s second commercial facility for developers of advanced biologics. Backed by the resources of its new majority stakeholder, SK Pharmteco, Yposkesi is investing $71 million in the new, 5,000 m2 site which will make the plant one of Europe’s largest ATMP (Advanced Therapy Medicinal Products) facilities. CBI will build the facility while engineering firm Pharmaplan will serve as the prime contractor.
“Project SKY,” as the expansion is named, will create approximately eighty new jobs. It doubles Yposkesi’s production capacity footprint, and is expected to address current shortages in manufacturing capacity for drug developers in general ATMP areas.
Alain Lamproye, executive chairman of Yposkesi, notes that Project SKY was “the culmination” of his firm’s industrial strategy and would support “early clinical drug development through … the manufacture of large-scale commercial batches of ATMPs.” This capability comes through the construction of two new production lines incorporating several 1000-L bioreactors.
Construction on Project SKY began in late May 2021, on a site adjacent to Yposkesi’s current 5,000m2 commercial facility. The large-capacity (for ATMPs) bioreactors, chromatography skids, and other purification capabilities will be in place by 2023, with full qualification expected at some point in 2023.
Morad El Gueddari, production director and head of Project SKY, noted that “manufacturing is an essential part of any drug developer’s success … [and] SKY is the key to getting us there.”
However, when asked specifically about Biopharma 4.0—designing the plant for advanced sensors and controls—Lamproye says that, given constant improvement in production technology and the novelty of ATMPs, the company would follow normal practice and implement these technologies as needed.
“Processes for producing viral vectors are rapidly evolving, with new technologies and innovation continuously coming into play,” Lamprove tells GEN. “We did not implement advanced controls and sensors at this stage for our processes, but will continuously evaluate this going forward.”
In other words, meeting urgent, current market demand is a higher priority, at least for now, than Biopharma 4.0.
“As the gene therapy pipeline matures and with so many products entering pivotal or late-stage clinical trials, combined with an overall increase in the number or programs, there is great need for additional, large scale capacities for manufacturing these products,” according to Lamproye.