ISSN:
1573-904X
Keywords:
monoclonal antibody–drug conjugate
;
vinca alkaloid
;
solution stability
Source:
Springer Online Journal Archives 1860-2000
Topics:
Chemistry and Pharmacology
Notes:
Abstract A 3-month solution stability study at 5°C of the monoclonal antibody–vinca alkaloid conjugate KS1/4-DAVLB indicated that phosphate-buffered saline solutions at pH 4.5–5.5 had little tendency to lose vinca by hydrolysis, improved vinca stability, showed acceptable physical stability, and formed minimal amounts of soluble aggregates compared to solutions at pH 6.5–7.4. Hydrolysis and aggregation with concomitant loss of stability were accelerated at 30°C throughout the pH range investigated. As determined by ELISA, the binding properties of KS1/4-DAVLB to tumor antigens were not affected by pH or temperature. A formulation suitable for initial clinical trials in cancer patients is described.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1015899612117
Permalink