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Table 1 Characterization of PRO-169

From: Safety and tolerability evaluation after repeated intravitreal injections of a humanized anti-VEGF-A monoclonal antibody (PRO-169) versus ranibizumab in New Zealand white rabbits

Test

Method

PRO-169

Quality

Appearance

Slightly yellow, opalescent liquid

pH

6.2

Charge of heterogeneity

CEX-HPLC

55.1% main peak, 34.3% acidic variants, and 10.7 basic variants

Structure

Intact mass LC/MS, G0F/G0F

149201 Da

Deglycosylated partially reduced LC/MS

Light chain mass = 23450.8 Da, deglycosylated heavy chain mass = 49717.5 Da

Oligosaccharide profile

N-Glycan profiling

79.2% G0, 16.1% G1, and 0.9% G2

Other

SPR

KD = 6.54 × 10−6

Vitreous Pharmacokinetics

SPR

CMax ± SD = 593.7 ± 42.6 µg/ml

TMax ± SD = 0.53 ± 0.8 days

T1/2 ± SD = 4.99 ± 0.9 days

  1. CEX-HPLC: cation exchange chromatography-high performance liquid chromatography; CMax: peak maximum concentration; KD: binding constant; LC/MS: liquid chromatography/mass spectrometry; SD: standard deviation; SPR: surface plasmon resonance; T1/2: half-life time; TMax: time to maximal concentration