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The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Patent No.:

US 11524987 B1

PDFFull Text
Date of Patent:
Dec. 13, 2022

Filed:

Sep. 25, 2019

Highly purified recombinant human insulin (rhi) api and methods of producing the same

Applicant:

Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA (US);

Inventors:

Jie Fei Ding, Riverside, CA (US);

Aili Bo, La Verne, CA (US);

Jack Yongfeng Zhang, Diamond Bar, CA (US);

Mary Zi-ping Luo, Diamond Bar, CA (US);

Zhongli Bao, Chino Hills, CA (US);

Assignee:

AMPHASTAR PHARMACEUTICALS, INC., Rancho Cucamonga, CA (US);

Attorney:

Lewis Roca Rothgerber Christie LLP

Primary Examiner:

Jeanette M Lieb

Int. Cl.
CPC ...
C07K 14/62 (2006.01); B01D 9/00 (2006.01); B01D 15/18 (2006.01); B01D 15/32 (2006.01); B01D 15/36 (2006.01); C07K 1/06 (2006.01); C07K 1/16 (2006.01); C07K 1/18 (2006.01); C07K 1/30 (2006.01); C07K 1/36 (2006.01);
U.S. Cl.
CPC ...
C07K 14/62 (2013.01); B01D 9/0059 (2013.01); B01D 15/1871 (2013.01); B01D 15/325 (2013.01); B01D 15/363 (2013.01); C07K 1/063 (2013.01); C07K 1/16 (2013.01); C07K 1/18 (2013.01); C07K 1/306 (2013.01); C07K 1/36 (2013.01); C07B 2200/13 (2013.01);
Abstract

Methods are disclosed for producing highly purified recombinant human insulin (RHI) having a purity of 99.0% (w/w) or greater, a Total Impurity (not including the related substance desamido Asn-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclosed are API compositions of highly purified RHI having a purity of 99.0% (w/w) or greater, a Total Impurity of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less.

Find Patent Forward Citations

Ding, Jie. (2022). Highly purified recombinant human insulin (rhi) api and methods of producing the same (U.S. Patent No. 11524987). U.S. Patent and Trademark Office. https://idiyas.com/patent/badge/11524987

Data source: USPTO (United States Patent and Trademark Office) public patent records. Weekly synchronization. How IDiyas builds this profile

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