. 2023 Oct 13;23(4):421–438. doi: 10.1007/s40268-023-00441-7

Table 2.

Summary of select physicochemical attribute results from the analytical similarity assessment of ABP 654 and ustekinumab (US and EU)

Analytical testing/attributes	ABP 654 [range (n)]	Ustekinumab US [range (n)]	Ustekinumab EU [range (n)]
Glycan map (%)^a
High mannose Sialylation Afucosylation β-Galactosylation α-Galactosylation	2.0–3.7 (22) 22.3–29.5 (22) 1.2–2.2 (22) 54.1–58.8 (22) NA	0.7–1.8 (27) 8.5–24.8 (27) 3.7–4.8 (27) 19.2–56.5 (27) 0.4–4.9 (27)	0.7–1.2 (40) 16.7–26.4 (40) 3.2–5.1 (40) 47.9–54.1 (40) 1.3–4.9 (40)
FTIR/spectral similarity (%)^b
US RP as standard EU RP as standard	98.47–99.96 (6) 99.18–99.94 (6)	98.69–100.00 (6) 98.59–99.96 (6)	98.59–99.96 (6) 99.20–100.00 (6)
Near UV-CD/spectral similarity (%)^b
US RP as standard EU RP as standard	97.21–98.52 (6) 97.00–98.84 (6)	97.19–100.00 (6) 96.96–98.53 (6)	96.94–98.53 (6) 95.95–100.00 (6)
DSC (°C)^b
T_m1 T_m2	75.1–75.2 (6) 84.5–84.6 (6)	75.1–75.2 (6) 84.3–84.4 (6)	75.1–75.2 (6) 84.4–84.5 (6)
Size variants by SE-UHPLC (%)^b,c
HMW	0.5–0.8 (22)	0.3–0.5 (22)	0.3–0.4 (33)
Size variants by rCE-SDS^b
Heavy chain + light chain^c Fragments^c Non-glycosylated heavy chain	97.8–98.8 (22) 0.4–0.9 (22) 0.4–0.5 (22)	98.6–99.3 (22) 0.2–0.7 (22) 0.2–0.3 (22)	98.3–99.3 (33) 0.2–0.7 (33) 0.2–0.3 (33)
Size variants by nrCE-SDS^b,c
Main peak Pre-peaks	96.4–97.8 (22) 2.0–3.4 (22)	98.3–99.0 (22) 1.0–1.6 (22)	98.0–98.8 (33) 1.2–1.7 (33)
Charge variants by CEX-HPLC^b
Acidic peaks Main peak Basic peaks	46.3–56.4 (22) 41.2–47.2 (22) 2.3–6.5 (22)	14.8–27.5 (22) 30.1–47.6 (22) 34.3–46.3 (22)	23.0–27.0 (33) 28.7–42.0 (33) 34.1–46.3 (33)
AUC-SV monomer (%)^b	98.1–99.4 (6)	98.5–99.6 (6)	98.8–99.5 (6)
SE-HPLC–LS MW (kDa)^b
Monomer HMW	144–147 (6) 282–312 (6)	144–147 (6) 286–312 (6)	144–147 (6) 282–340 (6)

Analytical testing/attributes

ABP 654 [range (n)]

Ustekinumab US [range (n)]

Ustekinumab EU [range (n)]

Glycan map (%)^a

High mannose

Sialylation

Afucosylation

β-Galactosylation

α-Galactosylation

2.0–3.7 (22)

22.3–29.5 (22)

1.2–2.2 (22)

54.1–58.8 (22)

0.7–1.8 (27)

8.5–24.8 (27)

3.7–4.8 (27)

19.2–56.5 (27)

0.4–4.9 (27)

0.7–1.2 (40)

16.7–26.4 (40)

3.2–5.1 (40)

47.9–54.1 (40)

1.3–4.9 (40)

FTIR/spectral similarity (%)^b

US RP as standard

EU RP as standard

98.47–99.96 (6)

99.18–99.94 (6)

98.69–100.00 (6)

98.59–99.96 (6)

99.20–100.00 (6)

Near UV-CD/spectral similarity (%)^b

US RP as standard

EU RP as standard

97.21–98.52 (6)

97.00–98.84 (6)

97.19–100.00 (6)

96.96–98.53 (6)

96.94–98.53 (6)

95.95–100.00 (6)

DSC (°C)^b

T_m1

T_m2

75.1–75.2 (6)

84.5–84.6 (6)

75.1–75.2 (6)

84.3–84.4 (6)

75.1–75.2 (6)

84.4–84.5 (6)

Size variants by SE-UHPLC (%)^b,c

HMW

0.5–0.8 (22)

0.3–0.5 (22)

0.3–0.4 (33)

Size variants by rCE-SDS^b

Heavy chain + light chain^c

Fragments^c

Non-glycosylated heavy chain

97.8–98.8 (22)

0.4–0.9 (22)

0.4–0.5 (22)

98.6–99.3 (22)

0.2–0.7 (22)

0.2–0.3 (22)

98.3–99.3 (33)

0.2–0.7 (33)

0.2–0.3 (33)

Size variants by nrCE-SDS^b,c

Main peak

Pre-peaks

96.4–97.8 (22)

2.0–3.4 (22)

98.3–99.0 (22)

1.0–1.6 (22)

98.0–98.8 (33)

1.2–1.7 (33)

Charge variants by CEX-HPLC^b

Acidic peaks

Main peak

Basic peaks

46.3–56.4 (22)

41.2–47.2 (22)

2.3–6.5 (22)

14.8–27.5 (22)

30.1–47.6 (22)

34.3–46.3 (22)

23.0–27.0 (33)

28.7–42.0 (33)

34.1–46.3 (33)

AUC-SV monomer (%)^b

98.1–99.4 (6)

98.5–99.6 (6)

98.8–99.5 (6)

SE-HPLC–LS MW (kDa)^b

Monomer

HMW

144–147 (6)

282–312 (6)

144–147 (6)

286–312 (6)

144–147 (6)

282–340 (6)

AUC-SV analytical ultracentrifugation sedimentation velocity, CEX-HPLC cation exchange high-performance liquid chromatography, DSC differential scanning calorimetry, FTIR Fourier-transform infrared spectroscopy, HMW high molecular weight, MW molecular weight, n number of lots tested, NA not available, nrCE-SDS non-reduced capillary electrophoresis—sodium dodecyl sulfate, PFS prefilled syringe, T_m thermal transition temperature, rCE-SDS reduced capillary electrophoresis—sodium dodecyl sulfate, RP reference product, SE-UHPLC size-exclusion ultra-high-performance liquid chromatography, SE-HPLC–LS size exclusion high-performance liquid chromatography with light scattering, ustekinumab (EU) European Union-authorized ustekinumab, UV-CD ultraviolet circular dichroism, ustekinumab (US) United States Food and Drug Administration-licensed ustekinumab

^a130 mg vial results included with PFS and 45 mg vial ustekinumab results

^bPFS, 45 mg vial, and/or drug substance

^cAge-adjusted