Mammalian Cell Culture
Sandoz has operated a cell culture plant with 3 000 L and 13 000 L fermentation/ purification lines since 2004 in Schaftenau, Austria. In 2008, the plant was further extended with an additional fully integrated 2 x 13 000 L fermentation line including a corresponding downstream unit, allowing Sandoz to offer development and cGMP production capacity at a range of scales in the field of mammalian cell culture for third parties.
The plant has a highly flexible, modular design and comprises several small scale lines as well as one 150 L line that are utilized for development and technology transfer. The fermentation units are operated in fed batch mode and are linked to fully equipped, separated downstream processing lines. All facilities are designed as multipurpose plants, thus enabling maximum flexibility in capacity utilization. The facilities have been designed in close contact with regulatory authorities and meet the latest cGMP requirements.
Sandoz is the pioneer and undisputed global leader in the rapidly emerging market for biosimilars.