Formation of acidic antibody variants can occur at any point during product manufacturing or product storage, and may affect product efficacy and antibody stability. Our protein of interest (POI) was found to contain inherently high levels of acidic variants, due to its multiple deamidation sites. High throughput screening (HTS) and design of experiment (DoE) showed that designing a purification scheme to clear acidic variants once generated would be cost-prohibitive, and the resulting impact on process yield would be consequential. As an alternative, parameters such as cell culture duration in conjunction with harvest and product storage conditions, as well as the early purification steps were optimized to minimize the rate of variant formation. This poster presents data around the integrated upstream and early purification efforts that led to an effective control of acidic variant formation.  Acceptable variant levels in the final drug substance were achieved without any effect on process yield.

Integrated upstream and downstream strategy to control the level of acidic variants and improve downstream productivity for a monoclonal antibody

243rd National Meeting (2012)

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