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

Table 1

Data of Perjeta® and N-glycan-related characterization results.

Group	Batch	Expiry date	N-glycan profile		ADCC (%relative activity)
			%Afucose	%Galactose	EC50	Maximum response	-prob
High	H0323B07	Aug-20	4.2	11.8	100	100	RS
	H0324B01	Aug-20	4.1	9.7	96	103	0.609
	H0382B04	Aug-21	3.7	9.1	84	96	0.129
Medium	H0337B01	Oct-20	2.6	15.4	82	86	4.8-6
	H0340B01	Nov-20	2.4	18.5	73	88	4.0-6
Low	H0371B01	May-21	2.1	12.4	91	72	1.1-5
	H0388B01	Sep-21	2.3	14.3	81	74	1.3-4
	H0394B01	Sep-21	2.1	15.2	73	74	1.6-11
	H0391B01	Sep-21	2.1	15.3	71	78	9.4-12
	H0389B01	Sep-21	1.9	15.0	76	70	3.6-8
	H0383B01	Sep-21	1.8	15.4	78	70	1.7-8
	H0395B02	Oct-21	2.1	15.4	76	75	2.4-10
	H0396B01	Oct-21	2.1	15.6	71	80	9.1-10
Mean ()			2.6	14.1	80.9	82.0	NA
SD ()			0.8	2.6	9.5	11.5
RSD (%)			30.8	18.4	11.7	14.0