You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 10,267,754


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,267,754
Title:Assessing biopharmaceutical aggregation using magnetic resonance relaxometry
Abstract: The present invention generally relates to a method of using NMR relaxation rates (R.sub.2) of water molecules as an indicator of the extent of aggregation of biopharmaceutical formulations. The biopharmaceutical can be evaluated nondestructively without the vial or container being opened or protective seal compromised (i.e., broken). The method is applicable to all biopharmaceuticals and the water signal obtained by magnetic resonance relaxometry is very strong and sensitive because water is used as the solvent and is present in high (>90%) concentrations in every biopharmaceutical formulation.
Inventor(s): Yu; Yihua Bruce (Baltimore, MD), Taraban; Marc (Baltimore, MD), Feng; Yue (Baltimore, MD)
Assignee: UNIVERSITY OF MARYLAND, BALTIMORE (Baltimore, MD)
Application Number:14/780,711
Patent Claims:1. A method of measuring an extent of aggregation of a biopharmaceutical in a biopharmaceutical-containing product, said method comprising: measuring the transverse relaxation rate of water R.sub.2 in the biopharmaceutical-containing product, wherein the biopharmaceutical-containing product is contained in a vial; and comparing the measured R.sub.2 of water to a calibration curve to determine the extent of aggregation of the biopharmaceutical in the vial, wherein the water R.sub.2 is measured without opening the vial or otherwise accessing the contents of the vial containing the biopharmaceutical-containing product.

2. The method of claim 1, wherein the R.sub.2 is measured using nuclear magnetic resonance (NMR) or magnetic resonance imaging (MRI).

3. The method of claim 1, wherein the calibration curve is prepared by plotting relaxation rate R.sub.2 versus the extent of known aggregation at a given temperature.

4. The method of claim 1, wherein the R.sub.2 can be measured without adding any additives to the vial containing the biopharmaceutical-containing product.

5. The method of claim 1, wherein the biopharmaceutical is selected from the group consisting of a protein, a peptide, a nucleic acid, and a polysaccharide.

6. The method of claim 1, wherein the biopharmaceutical is selected from the group consisting of a hormone, a blood factor, an interferon, a haematopoietic growth factor, an interleukin-based product, a vaccine, and a monoclonal antibody.

7. The method of claim 1, wherein the biopharmaceutical is selected from the group consisting of bovine serum albumin, human serum albumin, human .gamma.-globulin, insulin, glucagon, gonadotrophins, growth hormone, erythropoetin, Factor VIII, Factor IX, thrombolytic agents, interferon-.alpha., interferon-.beta., interferon-.gamma., interleukin-2, influenza vaccine, adalimumab, rituximab, infliximab, trastuzumab, ustekinumab, denosumab, golimumab, Fc fragments, Fab fragments, intravenous immunoglobulin (WIG), tumor necrosis factor, abatacept, alefacept, etanercept, denileukin diftitox, OPTISON, NEUPOGEN, albumin, and ribonuclease A.

8. The method of claim 1, wherein the extent of aggregation is the % aggregation of the biopharmaceutical, the concentration of the biopharmaceutical aggregates, or the molecular weight of the biopharmaceutical aggregates.

9. The method of claim 1, further comprising comparing the extent of aggregation to the maximum acceptable extent of aggregation to determine if the biopharmaceutical is still viable.

Details for Patent 10,267,754

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 2033-04-12
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2033-04-12
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2033-04-12
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2033-04-12
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 02/17/1995 ⤷  Try a Trial 2033-04-12
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 06/11/2003 ⤷  Try a Trial 2033-04-12
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.