USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES - Quality by Design for Biopharmaceuticals - page 79

Figure 4.26. Native IEF analysis of palivizumab isolated from human PK samples. Lanes: (1) pI
marker; (2) palivizumab reference standard; (3) palivizumab 15min PK sample; (4) palivizumab 7
days PK sample.
Figure 4.27. Comparison of palivizumab reference standard and buffer-deamidated material
in the RSV microneutralization assay.
Figure 4.28. Cotton rat PK analysis of serumpalivizumab levels after dosingwithuntreated and
buffer-deamidated palivizumab.