Biomanufacturing of monoclonal antibodies (MAb) involves a number of unit operations, including cell culture in a bioreactor followed by chromatography and filtration. Purification is intended to remove impurities, such as protein aggregates, but some such operations may actually generate protein aggregation (1). Table 1 summarizes potential sources of aggregate formation during biomanufacturing processes. Aggregates are multimers of native, partially denatured, or fully denatured proteins. Their presence in biological formulations can trigger detrimental immunogenic responses upon administration (2). Moreover, aggregates can…