Drifts in N-Linked Glycosylation Result in ADCC Potency Variation of Perjeta® from August 2020 to October 2021 in China

Figure 1

Quality attributes of Perjeta®, which are consistent among all the monitored batches. Size variant profiles assessed by (a) SEC-HPLC and (b) NR CE-SDS; charge variant profiles assessed by (c) IEX-HPLC and (d) icIEF; unpaired cysteine variant profiles assessed by (e) HIC-HPLC: the samples were digested by CpB and IgdE enzyme. (f) RP-HPLC: the samples were reduced by DTT. Three typical batches of Perjeta® are displayed, including one batch (H0382B04) from the high-afucose level group, one batch (H0340B01) from the medium-afucose level group, and one batch (H0383B01) from the low-afucose level group. HMW: high molecular weight impurities; LMW: low molecular weight impurities.

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