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The Effects Of Media Formulations On The Biochemical Profile Of IgG Expressed In Sp2/0 Cells As Measured By Cation Exchange HPLC
October 1, 2007
•The Effects Of Media Formulations On The Biochemical Profile Of IgG Expressed In Sp2/0 Cells As Measured By Cation Exchange HPLC
One of the major concerns for the biopharmaceutical industry is maintaining the product quality parameters of recombinant proteins such as humanized monoclonal antibodies (MAb's) when process changes occur during product development. Changes in the biochemical profile of a protein product could affect its therapeutic or pharmacokinetic properties and require repeating preclinical or clinical studies(1-3). Since charge heterogeneity is commonly observed with recombinant MAb's, one of the assays typically used to analyze product quality is cation exchange (CEX) HPLC(4). Charge heterogeneity can result from multiple causes such as deamidation, oxidation, amino acid changes, sialic acid addition to glycoforms, N-terminal pyroglutamic acid, and C-terminal lysine clipping(4-7).
In a recent media development project for a recombinant IgG expressed in Sp2/0 cells, our goal was to maintain a specifi c CEX profile while achieving target productivity levels. We used a combination of media screening and mixing experiments in shake flask cultures to identify formulations that maximized cell growth and productivity while maintaining the desired product quality parameters as measured by CEX HPLC. Further productivity and product quality improvements were achieved by optimizing feed supplements. The final media formulation and fed-batch process identified by these studies exceeded the target productivity of 800 mg/L and closely matched the reference CEX HPLC profile for product quality.
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•The Effects Of Media Formulations On The Biochemical Profile Of IgG Expressed In Sp2/0 Cells As Measured By Cation Exchange HPLC
SOURCE: SAFC
