Wspólnotowy Serwis Informacyjny Badan i Rozwoju - CORDIS

Evaluation of bcl-2 over-expressing NS0 cell lines in state-of-the-art antibody manufacturing process

The behaviour of a GS-NS0 cell line expressing a model antibody was compared with that of the same cell line over-expressing the Bcl-2 protein (this cell line was generated in a previous EU project) in state-of-the-art antibody manufacturing process.

The process was scaled down from a fermentation process used at the 5000 L scale for the commercial manufacture to GMP of therapeutic antibodies by Lonza Biologics. The expected increase in space-time yield of viable biomass was seen. However, no increase in antibody concentration was seen: this is in contrast with results generated with these cell lines by one of the contractors (Al-rubeai) in the previous EU-funded programme. The over-expression of Bcl-2 also appeared to adversely affect the operations to separate cell debris from the feedstream for the purification process.

These data, which to the contractors' knowledge are the first time that Bcl-2 over-expressing cell lines have been evaluated in a state-of-the-art manufacturing process, show that introduction of such cell lines into current manufacturing processes will not simply be a case of making minor adjustments to existing processes.

Work has been presented at a number of meetings where other manufacturers of therapeutic antibodies were present.

Reported by

Lonza Biologics
228 Bath Road
SL1 4DX, Slough
United Kingdom
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