Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

Figure 7

Immunogenicity assessment of ABD variants. (a) Predicted immunogenicity scores for three ABD variants and parental sequence ABD001. (b) Relative CD4+ T cell proliferation responses to ABD variants in a cohort of 52 donors, expressed as number of donors with proliferative responses to each of the ABD variants compared to negative (rHSA) and positive (KLH) controls. (c) CD4+ T cell proliferation responses to ABD variants in a cohort of 52 donors expressed as mean stimulation indices (SI) over the population. rHSA is used as a reference (SI = 1).

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