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US 9,068,957 B2Granted
Evaluating heparin preparations
AssigneeMomenta Pharmaceuticals, Inc.
InventorsNur Sibel Gunay, Miroslaw Lech, Sucharita Roy, John Schaeck, Jennifer Ozug, Daniela Beccati, Ishan Capila
Life of this patent
Estimating the term…
Abstract
Methods of evaluating heparin preparations, e.g., for suitability for use as a drug or for use in making a drug, by determining the absence, presence or amount of a structural signature, wherein, e.g., the structural signature is indicative of the methods used to make the heparin preparation.
Claims21
A method of identifying if a process was used to make a heparin preparation, comprising:
- performing a separation process on a sample of the heparin preparation determining if a structural signature of one or more of:
- wherein R═SO3− or H and Y═SO3− or Acetyl, is absent from, present in, or present in an amount in, the separated heparin sample, wherein the presence or amount of the structural signature in the separated heparin sample indicates that the heparin preparation was made by a treatment method that includes treatment with a base, and/or an oxidation process, followed by treatment with a sulfite, and the absence of the structural signature in the separated heparin sample indicates that the heparin preparation was not made by the treatment method;
- and
- if the heparin preparation was made by the treatment method, performing a step, wherein the step is one or more of classifying, selecting, accepting, discarding, releasing, withholding, processing into a drug product, shipping, formulating, labeling, packaging, releasing into commerce, selling, and offering for sale the heparin preparation.
1 more element
A method of evaluating a heparin preparation, comprising:
- identifying if a process was used to make the heparin preparation
- performing a separation process on a sample of the heparin preparation determining if a structural signature of one or more of:
- wherein R═SO3− or H and Y═SO3− or Acetyl, is absent from, present in, or present in an amount in, the separated heparin sample, wherein the presence or amount of the structural signature in the separated heparin sample, indicates that the heparin preparation was made by a treatment method that includes treatment with a base, and/or an oxidation process, followed by treatment with a sulfite, and the absence of the structural signature in the separated heparin sample, indicates that the heparin preparation was not made by the treatment method;
- and
- if the heparin preparation was made by the treatment method, performing a step, wherein the step is one or more of classifying, processing into a drug product, formulating, labeling, and packaging the heparin preparation.
2 more elements
A method of producing a LMWH comprising:
- providing an unfractionated heparin (UFH) sample from an UFH preparation;
- performing a separation process on the UFH sample to determine if a structural signature of one or more of:
- wherein R═SO3− or H and Y═SO3− or Acetyl, is absent from, present in, or present in an amount in, the separated UFH sample, wherein the presence or amount of the structural signature in the separated UFH sample, indicates that the UFH preparation was made by a treatment method that includes treatment with a base, and/or an oxidation process, followed by treatment with a sulfite, and the absence of the structural signature in the separated UFH sample, indicates that the UFH preparation was not made by the treatment method;
- and
- processing the UFH preparation made by the treatment method into a LMWH.
2 more elements
A method of producing a LMWH comprising:
- performing a separation process on a LMWH sample from a LMWH preparation to determine if a structural signature of one or more of:
- wherein R═SO3− or H and Y═SO3− or Acetyl, is absent from, present in, or present in an amount in, the separated LMWH sample, wherein the presence or amount of the structural signature in the separated LMWH sample, indicates that the LMWH preparation was made by a treatment method that includes treatment with a base, and/or an oxidation process, followed by treatment with a sulfite, and the absence of the structural signature in the separated LMWH sample, indicates that the LMWH preparation was not made by the treatment method;
- and
- processing the LMWH preparation made by the treatment method into a drug product or formulating the LMWH preparation.
1 more element
Dependencies are inferred from the claim text.