Waters Technologies Corporation

Bristol-myers Squibb Compnay

Xin Zhang

Pamela Carmen Iraneta

Frank John Marszalkowski, Jr

Kevin Daniel Wyndham

Raymond P Fisk

Thomas H Walter

Daniel P Walsh

Moon Chul Jung

Zhengjian Li

Pamela J Longenbach

Letha Chemmalil

Julia Ding

The present disclosure provides icIEF sample matrices that enable icIEF analysis of PEGylated proteins in their real conjugated states. The sample matrices of the present disclosure can include glycine, which enables the separation of co-migrated PEGylated protein charge variants. The sample matrices can also include taurine, which further improves icIEF assay by depleting matrix induced baseline interferences. Accordingly, a sample matrix of the present disclosure including a combination of glycine and taurine enables icIEF separation of acidic and basic species from the main peak for PEGylated proteins, allowing the identification/separation, characterization and quantification of discrete PEGylated protein species. By using the sample matrices of the present disclosure to characterize PEGylated proteins by icIEF, repeatability, linearity, accuracy, sample stability, and method robustness are achieved.

Isoelectric focusing sample matrix

Disclosed is a device for a solid phase extraction comprising two or more of the sorbents to remove phospholipids and salts from a sample, to thereby eliminate matrix effects during mass spectrometry analysis. In particular, the sorbents includes at least one sorbent which is water-wettable and contains at least one hydrophobic component and at least one hydrophilic component and at least one of sorbent having a specific affinity for a matrix interference like phospholipids. Further disclosed is a method using the device of the present invention.

Device for solid phase extraction and method for use thereof

Methods, kits and devices for separating phospholipids and proteins from small molecules in biochemical samples can feature an apparatus having a wetting barrier, at least one frit and a separation media. For example, an apparatus can include at least one wall defining a chamber having an exit and an entrance; a wetting barrier disposed between the exit and entrance, so as to define a separation media space located between the wetting barrier and the exit and a sample receiving area located between the wetting barrier and the entrance; and a separation media disposed adjacent to the wetting barrier and having a specific affinity for phospholipids.

Methods, compositions, devices, and kits, for performing phospholipid separation

Methods, kits and devices for separating phospholipids and proteins from small molecules in biochemical samples can feature an apparatus having a wetting barrier, at least one fit and a separation media. For example, an apparatus can include at least one wall defining a chamber having an exit and an entrance; a wetting barrier disposed between the exit and entrance, so as to define a separation media space located between the wetting barrier and the exit and a sample receiving area located between the wetting barrier and the entrance; and a separation media disposed adjacent to the wetting barrier and having a specific affinity for phospholipids. The wetting barrier is adapted to (i) retain the liquid sample and a protein precipitating agent in the sample receiving area under a first force, thereby facilitating the formation of a protein precipitate and a processed sample, and (ii) flow the processed sample through the wetting barrier and separation media under a second force, wherein the second force is greater than the first force, thereby retaining the protein precipitate in the sample receiving area, retaining phospholipids in the separation media, and eluting small molecules.

Methods, compositions, devices, and kits for performing phospholipid separation

Described is a biological sample carrier based on a rigid hydrophilic object fabricated from a non-absorbing inert porous material. A biological fluid sample applied to the surface of the object is absorbed into the pores and constituents of the biological fluid sample remain in the pores after drying. Unlike a disc punched from a conventional dried blood spot (DBS) card, the object is easily handled. In contrast to DBS cards containing glass fiber structures that interact with basic analytes and other DBS card having adsorbing fibers that tend to separate blood constituents as the sample spreads through the fibers, the biological sample carrier is substantially inert to drug analytes.

Growing community of inventors

Newton, MA, United States of America

Xin Zhang