Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics
Fig 6
The IVCIA assay can be used to compare mAb lots from both the same manufacturer and from different manufacturers (biosimilars).
A) Several different lots of Erbitux (2 lots), Remicade (2 lots) and Humira (5 lots) were tested in the IVCIA assay for a response at the early (20 h) phase (n = 12 donors), at 40 μg/mL. The concentration (pg/mL) of signature cytokines that were secreted 20 hours after stimulation is shown. B) Biosimilars, Humira and ABP 501, from two different manufacturers were compared in the IVCIA assay for the secretion of signature cytokines at the early (20 h) and late (7 day) phases (n = 4 donors), at 100 μg/mL. C) Multiple lots of another set of biosimilars, Herceptin and ABP 980, from two different manufacturers (which are both associated with a low rate of clinical immunogenicity), were assessed in the IVCIA assay at 40 μg/mL for T-cell proliferative responses on Day 7 only. No statistically different responses in the assay were observed between different lots of Herceptin and mAb5-B (p = 0.12). In all assays, the average response across the population tested was similar, although slightly different responses in specific donors could be observed. In all panels, bars in shades of white and grey show the average level of cytokine secretion at the early and late phases, and purple bars depict the average level of T-cell proliferation, across the population. Colored and black circles represent the response of individual donors and show the variability of the population tested.