中国生物工程杂志

Ever from FDA approved the Rituxan in 1997, an Anti-CD-20 chimeric antibody, there have been more than 20 antibodies approved and they have got into more than 56 countries. About half approvied antibodies are curing kinds of cancers and seven of them have got a excellent sale targets to be "Blockbuster Drug".As the cell culture technology improving, the large scale cell expression titer comes from 1g/L to 5g/L. At the same time, the culture scale is coming form 12,000L to 15,000L, even 20000L and it can run several bioreactors at the same time. All these are make the improvement of the antibody purification. The new edition of media, system, chromatography technology and filtration technology can product the protein to several tens kilogram antibody per cycle and tons per year, although the productivity is only several kilograms per cycle many years ago. Also the new combined technology makes a two-step chromatography production protocol come into been. This will highly improve the antibody productivity and save the investment cost. This paper will introduce this new production protocol particularly.