Patent US6566490B1 successfully refreshed from Google Patents.
US6566490B1
Expired / Lapsed
US
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Seeding crystals for the preparation of peptides or proteins
Assignee: Novo Nordisk AS
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Filing: 2000-12-20
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Granted: 2003-05-20
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Expires: 2020-12-20
Abstract
Abstract Disclosed is a method for producing seeding microcrystals for the production of human insulin, the microcrystals being free of non-human pancreatic insulin, the method comprising providing an unseeded suspension of human insulin, the suspension being free of non-human pancreatic insulin, and homogenizing the insulin suspension under pressure to result in human insulin microcrystals suitable for use as seeding microcrystals for the production of zinc insulin products. The method of homogenization under pressure may also be used for the production of seeding mnicrocrystals for other peptides and proteins, in particular pharmaceutical peptides or proteins such as insulin, GLP-1, glucagon and growth hormones.
Inventors
- 👤 Flemming Manique
- 👤 Christian Ilsoe
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 16:44
CPC Classifications
C; C07; C07K; C07K14/00; C07K14/435; C07K14/575; C07K14/62; C30; C30B; C30B29/00; C30B29/54; C30B29/58; C30B7/00
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
51 words
A method for producing seeding microcrystals for the production of a peptide or protein, comprising: providing an unseeded suspension of a peptide or protein and homogenizing said suspension under pressure to result in peptide or protein microcrystals suitable for use as seeding microcrystals for the production of said peptide or protein.
Claim 2
Independent Claim
51 words
A method for producing seeding microcrystals for the production of a peptide or protein, comprising: providing an unseeded suspension of a peptide or protein and homogenizing said suspension under pressure to result in peptide or protein microcrystals suitable for use as seeding microcrystals for the production of said peptide or protein.
Claim 3
Dependent Claim
17 words
The method of claim 1 , wherein the peptide or protein is a pharmaceutical peptide or protein.
Claim 4
Dependent Claim
31 words
The method of claim 2 , wherein the peptide or protein is selected from the group consisting of insulin, GLP-1, glucagon, and growth hormones, as well as analogues and derivatives thereof.
Claim 5
Dependent Claim
65 words
The method of claim 1 for producing seeding microcrystals for the production of human insulin, said microcrystals being free of non-human pancreatic insulin, comprising: providing an unseeded suspension of human insulin, said suspension being free of non-human pancreatic insulin, and homogenizing said insulin suspension under pressure to result in human insulin microcrystals suitable for use as seeding microcrystals for the production of zinc insulin products.
Claim 6
Dependent Claim
19 words
The method of claim 1 , wherein homogenization is performed at a pressure of at least about 500 bars.
Claim 7
Dependent Claim
14 words
The method of claim 1 , wherein homogenization is performed using multiple homogenization cycles.
Claim 8
Dependent Claim
22 words
The method of claim 6 , wherein the temperature of the suspension during said homogenizing step is controlled using a heat exchanger.
Claim 9
Dependent Claim
25 words
The method of claim 7 , wherein the temperature of the suspension during said homogenizing step is maintained within the range of about 10-40° C.
Claim 10
Dependent Claim
30 words
The method of claim 1 , wherein the microcrystals have an average particle size, as defined by the longest diagonal of the crystals, in the range of about 0.5-4 μm.
Claim 11
Independent Claim
59 words
A method for the production of a peptide or protein product, said method comprising: (i) providing a first unseeded suspension of a peptide or protein; (ii) homogenizing said unseeded suspension under pressure to result in microcrystals of said peptide or protein; and (iii) seeding a second unseeded suspension of said peptide or protein with microcrystals produced in step ii.
Claim 12
Independent Claim
59 words
A method for the production of a peptide or protein product, said method comprising: (i) providing a first unseeded suspension of a peptide or protein; (ii) homogenizing said unseeded suspension under pressure to result in microcrystals of said peptide or protein; and (iii) seeding a second unseeded suspension of said peptide or protein with microcrystals produced in step ii.
Claim 13
Dependent Claim
39 words
The method of claim 10 , wherein the peptide or protein product to be produced is a zinc insulin product, the first and second unseeded suspensions are suspensions of human insulin, and the seeding microcrystals are human insulin microcrystals.
References Cited (Backward Citations)
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WO1988002633A1
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 2006-05-19 | 2006-11-18 | 2007-05-20 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2010-05-19 | 2010-11-18 | 2011-05-20 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2014-05-19 | 2014-11-18 | 2015-05-20 | $7700.00 | Window Closed / Lapsed |