cGMP manufacturing of clinical & commercial batches
30+ years' experience in Cell & Gene Therapy
Yposkesi has four independent cGMP manufacturing suites where we perform either adherent (using 24CF10 cell factories) or suspension (total capacity of 2,000 L single use bioreactors) production processes. These suites are spacious enough to accommodate the installation of additional specific equipment, such as large single-use bioreactors (up to 500-1,000 L scale) as well as additional chromatography steps. These suites are Grade C and are operated at Biosafety level 2. Typical purification steps performed in these cGMP manufacturing areas include depth filtration, tangential flow filtration, chromatography (affinity, ion-exchange, and size exclusion).
The facility has an operational capacity of up to 32 batches per year, and Yposkesi is extending this capacity. By 2023, Yposkesi’s global footprint will double to 100,000 sq ft (approx. 10,000 m2) with a second large-scale facility designed for commercial production and in compliance with EMA and FDA regulations. Yposkesi invests significantly in innovation and bioprocessing to deliver on high quality and cost-effective production.