Cell line development is often a critical activity that limits the availability of material for starting other studies, e.g. formulation and buffer evaluation. The rapid availability of antibody produced in the same host cell and cell culture process as used in the final cGMP manufacturing process has the potential to reduce the duration of process development programs. Lonza has developed a generic method using pooled transfectants grown in chemically defined, animal-free (CDACF) medium, for the rapid production of small quantities (up to 50 g) of antibodies in CHO cells. Although slightly slower than a true transient system, the advantages include a higher product concentration and use of the same host and process as the production cell line.
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Figures 1 and 2: Example of growth and productivity of GS-CHO pools, expressing a model antibody, in a disposable bioreactor. Bioreactor culture was a 5 L working volume, operated in fed-batch mode with a harvest antibody concentration of 2 g/L within 9 weeks of transfection.