Table 2.
Summary of attributes for ABP 215, bevacizumab (US), and bevacizumab (EU).
| Analytical Testing/Attributes | ABP 215 Range (n) | Bevacizumab US Range (n) | Bevacizumab EU Range (n) |
|---|---|---|---|
| Intact molecular weight (Da) | |||
| A: Glycosylation – A2G0F:A1G0F | 149008–149017 (4) | 149007–149015 (4) | 149009–149025 (4) |
| B: Glycosylation – A2G0F:A2G0F | 149210–149219 (4) | 149210–149218 (4) | 149209–149218 (4) |
| C: Glycosylation – A2G0F:A2G1F | 149371–149381 (4) | 149374–149378 (4) | 149373–149381 (4) |
| D: Glycosylation – A2G1F:A2G1F or A2G0F:A2G2F | 149536–149541 (4) | 149531–149535 (4) | 149531–149538 (4) |
| E: Glycosylation – A2G1F:A2G2F | 149694–149698 (4) | 149673–149698 (4) | 149663–149710 (4) |
| Reduced and deglycosylated heavy chain (Da) | 49744–49752 (4) | 49741–49753 (4) | 49742–49753 (4) |
| Reduced and deglycosylated light chain (Da) | 23479–23482 (4) | 23479–23481 (4) | 23479–23482 (4) |
| Glycosylation at Asn303 (%) | 99.2–99.4 (13) | 97.9–98.3 (24) | 97.9–98.4 (26) |
| Glycan map (%) | |||
| High mannose | 1.2–2.7 (13) | 0.3–1.3 (23) | 0.5–1.2 (25) |
| Afucosylation | 1.2–1.7 (13) | 1.7–3.8 (23) | 1.9–2.6 (25) |
| Galactosylation | 17.1–29.4 (13) | 8.7–21.8 (23) | 7.8–21.2 (25) |
| Sialic acid | 0.2–0.3 (13) | 0.1–0.2 (23) | 0.1–0.2 (25) |
| FTIR/spectral similarity (%) | |||
| US RP | 97.6–99.8 (6) | 97.9–99.3 (6) | 97.2–99.0 (6) |
| EU RP | 97.9–99.8 (6) | 98.3–99.7 (6) | 97.5–99.3 (6) |
| Near UV-CD/spectral similarity (%) | |||
| US RP | 98.5–99.4 (6) | 98.5–99.6 (6) | 97.3–99.4 (6) |
| EU RP | 97.1–99.4 (6) | 97.0–99.6 (6) | 97.6–99.5 (6) |
| DSC (°C) | |||
| Tm1 | 72.7–73.1 (11) | 72.6–73.1 (12) | 72.5–73.1 (12) |
| Tm2 | 83.2–83.7 (11) | 83.2–83.9 (12) | 83.0–84.0 (12) |
| LO subvisible particle (particles/container) | |||
| ≥ 2 µm | 320–5736 (19) | 48–4749 (14) | 77–15493 (15) |
| ≥ 5 µm | 48–1488 (19) | 14–755 (14) | 24–688 (15) |
| ≥ 10 µm | 16–219 (19) | 3–112 (14) | 8–224 (15) |
| ≥ 25 µm | 0–96 (19) | 0–32 (14) | 0–32 (15) |
| MFI subvisible particle (particles/mL) | |||
| ≥ 5 µm spherical particles | 16–218 (19) | 42–3439 (11) | 51–588 (12) |
| ≥ 5 µm non-spherical particles | 0–65 (19) | 6–2157 (11) | 8–430 (12) |
| AUC-SV/monomer (%) | 98.0–99.3 (6) | 97.3–98.6 (6) | 97.3–98.6 (6) |
| SE-HPLC-LS MW (kDa) | |||
| Monomer | 148 (3) | 148 (3) | 148 (3) |
| Dimer | 297–304 (3) | 300–301 (3) | 294–298 (3) |
| Protein concentration (mg/mL) | 24.4–25.8 (13) | 23.9–25.9 (24) | 24.5–25.8 (26) |
| Volume (mL) | |||
| 100 mg/4 mL | 4.1–4.3 (7) | 4.2–4.3 (6) | 4.3–4.7 (5) |
| 400 mg/16 mL | 16.3–16.5 (12) | 16.2–16.6 (6) | 16.3–16.8 (8) |
| CHO cell protein by ELISA (ng/mg) | 4–12 (13) | 6 (3) | 5–6 (3) |
n indicates a number of samples tested