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Yposkesi doubles its viral vector production capabilities with a 5,000 m2 industrial bioproduction site expansion for cell and gene therapy manufacturing.
Yposkesi, a SK pharmteco subsidiary, will be able to provide its clients with improved year-round access to more easily scale-up cell and gene products with higher yields of high-quality viral vectors for cell and gene therapy projects, supporting the biopharma industry needs from early drug development to large-scale commercial manufacturing.
Yposkesi’s CEO, Alain Lamproye commented at the ribbon-cutting ceremony:
‘It is with great pleasure and pride that today we open the new Yposkesi viral vector manufacturing facility.’
The $65.3M expansion, located on the Genopole campus, adds to the existing 5,000 m2 cGMP manufacturing site, now 10,000m2 ,enabling product capacity to reach up to 75 batches per year, addressing the shortfalls in the supply of viral vectors, the preferred gene delivery system used to manufacture cell and gene therapy products. Yposkesi will be able to manufacture products in parallel and stagger batch starts to optimize its use.
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“This twin site enables us to stay up to pace with demand by producing larger quantities of C> 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> pipelines and commitments, making these treatments more accessible to patients,” explained Lamproye.
Currently undergoing qualification, the new site is scheduled to be fully operational in 2024, creating approximately 90 new jobs. In summary, the facility is designed with:
- Six Upstream Process and two Downstream Process clean rooms, tripling Ypokesi’s bioreactor capacity from 2000 L to 7,000 L – reducing turnaround times on projects from 18 months to 12 months
- Fill and finish capacities with semi-automated suites for a total of 12,000 vials per year
- Equipped to run both Adeno Associated Virus (AAV) and Lentiviral Vector (LV) platforms, notably LentisureTM, a CAR T-cell platform designed to optimize higher yields.
- Production capacity increased to up to 75 batches per year
- Current European and American GMP guidelines compliance
Yposkesi’s decision to extend its production capacity was fueled by its business continuity plan that aims to safeguard delivery guarantees for clients. Better access to viral vector manufacturing can accelerate the time to market for cell and gene therapies, creating better patient outcomes. Yposkei, in line with SK pharmteco’s ESG initiatives, also strived to be conscientious of incorporating green solutions into the design and construction.
Source: Yposkesi’s Press Release
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