Accelerating bioprocess workflows with microfluidic immunoassay-based parallel impurity analysis
Justine Collet-Brose and Pirjo Lehtonen
Gyros Protein Technologies AB, Uppsala Science Park, Dag Hammarskjölds väg 54, 751 83 Uppsala, Sweden
Minimizing the level of impurities during bioprocess development of biologics is critical and a regulatory requirement. These impurities can include host cell proteins (HCPs) from, for example, the Chinese Hamster Ovary (CHO) cell line, which is the most commonly used mammalian expression system. There is also the risk of hitchhiker antigens such as phospholipase B-like 2 (PLBL2), which co-purifies with multiple CHO-produced antibody therapeutics. Culture-related impurities can include albumin and transferrin and insulin from various species in serum-free media, while process-related impurities include protein A that has leaked from chromatographic columns.
The objective is to investigate the capability of Gyrolab® immunoassay systems for parallel impurity analysis of 5 common impurities:
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