ORAL PRESENTATION Open Access Identification of process parameters influencing product quality in mammalian cell culture

apeutics in the treatment of various diseases [1]. During manufacturing of mAbs higher molecular weight (HMW) aggregates can be formed during upstream (USP) and downstream (DSP) processing, which nega-tively influence product yields, reduce the therapeutic efficacy of the mAbs and trigger immunogenic responses upon administration [2,3]. Reducing the level of aggre-gates during USP could improve the production of bio-pharmaceuticals and reduce the burden on expensive DSP removal of the HMW species [4]. However, the lack of analytical tools to detect mAb aggregates in USP restricts understanding the origin of the aggregates and identifying cell culture conditions influencing product quality to reduce the level of mAb aggregates [5]. We present a high-throughput compatible method whic