USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES - Quality by Design for Biopharmaceuticals - page 73

Figure 4.20. Fractionation by IEC. Panel A: IEC profile of motivation; panel B: IEC fraction 1;
panel C: IEC fraction 2.

TABL E 4.4. Biological Characterization and IEC Fractions

F Protein Binding
ELISA (%) a

RSV
Microneutralization

F Protein Binding
Kinetics (SPR) K d (pM) Sample

Motavizumab
(unfractionated)

114 Neutralizes RSV 3.87

IEC fraction 1 112 Neutralizes RSV 4.58

IEC fraction 2 104 Neutralizes RSV 4.17

a Value listed is % binding relative to the reference standard.

Figure 4.21. Native IEF analysis of motavizumab spiked in human plasma. Lanes: (1) pI marker;
(2) reference standard; (3) initial time point; (4) 1 week in human plasma; (5) 2 weeks in human
plasma; (6) 3weeks in humanplasma; (7) 4weeks inhumanplasma; (8) 5weeks in humanplasma.