Dual wavelength isoelectric focusing for determining drug load in antibody drug conjugates
US9804079B2 · kind B2 · utility
Assignee
Inventor
Key dates
| Filing date | Apr 19, 2013 |
| Grant date | Oct 31, 2017 |
| Priority date | — |
| Expiry date | Sep 13, 2034 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG01N33/6857
- WIPO fieldMeasurement
- WIPO sectorInstruments
Abstract
Provided herein are IEF focusing methods for determining the number of drug molecules present in at least one antibody-drug conjugate (ADC) species subpopulation. In one embodiment, the method comprises performing free solution isoelectric focusing on a sample comprising at least one ADC species, to obtain a focused sample. The absorbance of the sample at two different wavelengths is then measured, for example, over a range of pI values. Absorbance values at the two different wavelengths are compared at at least one corresponding pI value, where the at least one corresponding pI value is the pI of the ADC subpopulation. The number of drug molecules in the at least one ADC species subpopulation is then determined based on the comparison. The methods provided herein can also be used to determine the number of specific binding pair members bound to its target specific binding pair member.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.