Proteinsimple

Jiaqi Wu

Christopher Heger

Tiemin Huang

Hui Xu

David John Roach

Tom Weisan Yang

Jessica Dermody

Roland Y Wang

Arthur H Watson

Cheng Zhou

Embodiments disclosed include systems, devices, and methods for analysis of samples containing particles used for gene delivery to determine a quality of the sample and/or an indication that the gene delivery particles are in a full, partial, and/or empty state. The present disclosure also relates to determining a protein and/or NA content in samples with known proportions of gene delivery particles in a full, partial, and/or empty state and based on the determination, establish a relationship between NA content and proportions of gene delivery particles in a full state. The present disclosure also relates to using such an established relationship to predict a proportion of the gene delivery particles in a full, partial, and/or empty state in test samples having the gene delivery particles in an unknown state.

Methods and systems for analysis of samples containing particles used for gene delivery

Embodiments include systems, apparatuses, and methods to efficiently separate analytes in a sample and elute fractions of the separated analytes. In some embodiments, a method includes introducing a sample in a capillary with a first end ionically coupled to a first running buffer and a second end ionically coupled to a second running buffer to form a pH gradient. The method includes applying a voltage between the first running buffer and the second running buffer, to separate a plurality of analytes in the sample. The method includes disposing the second end of the capillary in a collection well including a chemical mobilizer and applying a voltage to elute one or more analytes from the plurality of analytes in the sample, that have been separated, into the collection well. Embodiments include detection methods to monitor separation of analytes, mobilization of analytes, and/or elution of fractions containing analytes.

Systems and methods for fractionation and collection of analytes in a sample

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.

Dual wavelength isoelectric focusing for determining drug load in antibody drug conjugates

A method and apparatus are provided for performing capillary isoelectric focusing followed by mobilization of the focused zones by induced hydrodynamic flow or chemical mobilization. These two dimensions of separation are integrated with real-time whole-channel electrophoresis detection and automatic sample injection to achieve a separation resolution superior to that obtainable using known orthogonal capillary two dimensional arrangements.

Method to perform limited two dimensional separation of proteins and other biologicals

An apparatus and method are disclosed for the precise selection and extraction of a selected analyte in a focused zone produced by isoelectric focusing performed in micro-channels. A cross-channel microfluidic device comprises a sample mixture introduction and separation channel and an extraction channel, which are in fluid communication with each other at a point of intersection. Means are provided for selectively moving the pattern of separated zones following cIEF to the intersection point, and means are provided for applying an extraction pressure to direct a single zone containing a selected analyte into and then out of the extraction channel for collection.

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Woodbridge, Canada

Jiaqi Wu