Other

Emd Millipore Corporation

Tongbo Jiang

Ronald L Bruening

Anthony J DiLeo

Krzysztof E Krakowiak

Cheryl Follo

Maurice G Phelan

In accordance with an embodiment of the invention, there is provided a method for reducing or eliminating matrix interfering components in a biopharmaceutical product in a liquid chromatography-mass spectrometry system. The method comprises diverting to waste the entire flow of an eluant emerging from liquid chromatography of a sample, for a time period to remove contaminants that cause matrix interference to a degree sufficient to allow a desired accuracy in detection of an extractable; and, after the time period, directing the entire flow of the eluant to a mass spectrometer to detect the presence of the extractable.

System and method for diversion of a liquid chromatography eluant

The invention uses liquid chromatography-mass spectrometry to verify the presence or absence of the extractables introduced into a biopharmaceutical product during manufacture, filtration or storage at above a certain concentration. The method disclosed herein can be used to detect the presence of extractables in the actual biopharmaceutical product rather than a surrogate solvent system. Detection of the extractables in the actual drug product provides an accurate description of the leachables profile likely to be introduced to the human or animal patient. In one embodiment, the extractable are introduced by filtration of the bio-pharmaceutical product.

Method of detecting filter extractables in biopharmaceutical products by liquid chromatography-mass spectrometry

Compositions and methods for selectively binding specific metal ions, such as Ca and Cd , contained in a source solution are disclosed and described. This is accomplished by the use of a composition comprised of an EGTA ligand covalently bonded to a membrane support. The composition formula of the present invention is M&mdash;B&mdash;L where M is a membrane having a hydrophilic, partially hydrophilic or a composite membrane with a hydrophilic surface, B is a covalent linkage, and L is an EGTA ligand. The separation is accomplished by passing a source solution containing the ions to be separated through a device containing the membrane-ligand composition, causing the selected ions to be complexed to the EGTA ligands and subsequently removing the selected ions from the device by passing an aqueous receiving solution through the device and quantitatively stripping the selected ions from the EGTA ligand.

Polymeric membranes functionalized with EGTA ligands, and process of separating ions

The present invention provides methods for removing species of ions from biological solutions, thereby allowing controlled study of the biological effect of one or more ion on a biological system or environment. In general, a solution from which one or more ion species are to be removed is contacted with an ion binding ligand having an affinity for the desired ion wherein the ligand is bound to a substrate such as a solid support or membrane. After the ions have been bound by the ligand-substrate composition, the composition having the ions bound thereto is removed, leaving a solution with a reduced concentration of the one or more ions which were targeted. The biological solution may then be compared to a control biological solution in its original state, or ions may added back into the depleted biological solution at known concentrations. Under either scenario, the biological effects of one or more ions may be studied.

Use of ion binding ligands attached to solid supports and membranes for ion removal from a biological system

Methods, compositions and devices for purifying polypeptides and/or proteins using metal loaded ligand bound membranes by metal ion affinity chromatography are described.

Metal loaded ligand bound membranes for metal ion affinity chromatography

Compositions and methods for selectively binding specific metal ions, such as Ca and Cd , contained in a source solution are disclosed and described. This is accomplished by the use of a composition comprised of an EGTA ligand covalently bonded to a membrane support. The composition formula of the present invention is M-B-L where M is a membrane having a hydrophilic, partially hydrophilic or a composite membrane with a hydrophilic surface, B is a covalent linkage, and L is an EGTA ligand. The separation is accomplished by passing a source solution containing the ions to be separated through a device containing the membrane-ligand composition, causing the selected ions to be complexed to the EGTA ligands and subsequently removing the selected ions from the device by passing an aqueous receiving solution through the device and quantitatively stripping the selected ions from the EGTA ligand.

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Bedford, MA, United States of America

Tongbo Jiang