Biomedical Engineering Reference
In-Depth Information
Figure
4.16.
Glycoform levels in palivizumab isolated from human serum PK samples.
samples from clinical PK studies, and the major glycoform proportions in the isolated
products were determined. An example of such results for palivizumab is shown in
Fig. 4.16. We found no significant differences in the clearance rates for the major
glycoforms within the constraints of the method.
A mathematical model was used to calculate the individual clearance rates of the
major glycoforms in palivizumab and motavizumab, with a good fit of the data to the
model. Antibody concentration in time course serum samples from PK studies and
the relative oligosaccharide amount in the isolated antibody were used to develop this
mathematical model. The estimated AUC of the glycoforms G0, G1
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Man-5, and G2
relative to drug product are shown in Fig. 4.17.
For the purpose of thismodel, the relativeAUC estimates were computed, alongwith
90% confidence limits, at the outer bounds of the glycoform ranges that give rise to
Figure
4.17.
Modeling relative AUC for palivizumab and motavizumab glycoforms. (See the
insert for color representation of this figure.)
