The facility’s bioreactor hall contains three seed bioreactor trains to allow cell expansion for the production bioreactors.
These scale up cells from 24L, to 120L, to 600L, to 4,500L before being transferred to the 15,000L commercial scale tanks.
According to Jeong Won Yun, the seed trains use gravity flow for the transfer of cells and are equipped with fully automated controls and equipment for cleaning (CIP) and sterilisation (SIP).
“We have up to twenty inspections per year, and inspectors are always concerned about cross-contamination. We’ve never had any regulatory issues.”
As for the production bioreactors, the 15,000L tanks were made by Swiss firm BiOENGiNEERiNG. We asked whether Celltrion was looking into single-use systems at all, and while some disposable systems are being used at lab scale, Jeong Won Yun said that for now Celltrion believes single-use systems place control in the hands of the suppliers rather than the manufacturer – a view many large-scale manufacturers share.