HUT75678A - Non-denaturing potency assay for bovine somatotropin - Google Patents

Non-denaturing potency assay for bovine somatotropin Download PDF

Info

Publication number: HUT75678A
Authority: HU; Hungary
Prior art keywords: bst; bovine somatotropin; porous polymer; exclusion hplc; polymer gel
Prior art date: 1993-01-26

Application number

HU9502233A

Other languages

English (en)

Hungarian (hu)

Other versions

HU9502233D0 (en

Inventor

Jen P Chang

Original Assignee

Lilly Co Eli

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

1993-01-26

Filing date

1994-01-24

Publication date

1997-05-28

1994-01-24 Application filed by Lilly Co Eli filed Critical Lilly Co Eli

1995-09-28 Publication of HU9502233D0 publication Critical patent/HU9502233D0/hu

1997-05-28 Publication of HUT75678A publication Critical patent/HUT75678A/hu

Links

108010006025 bovine growth hormone Proteins 0.000 title claims description 185
238000003556 assay Methods 0.000 title description 11
238000000034 method Methods 0.000 claims description 75
238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 claims description 54
102000004169 proteins and genes Human genes 0.000 claims description 44
108090000623 proteins and genes Proteins 0.000 claims description 44
230000008569 process Effects 0.000 claims description 24
239000000243 solution Substances 0.000 claims description 24
229920000642 polymer Polymers 0.000 claims description 18
ATRRKUHOCOJYRX-UHFFFAOYSA-N Ammonium bicarbonate Chemical compound [NH4+].OC([O-])=O ATRRKUHOCOJYRX-UHFFFAOYSA-N 0.000 claims description 14
229910000013 Ammonium bicarbonate Inorganic materials 0.000 claims description 14
235000012538 ammonium bicarbonate Nutrition 0.000 claims description 14
239000001099 ammonium carbonate Substances 0.000 claims description 14
239000002245 particle Substances 0.000 claims description 14
239000007864 aqueous solution Substances 0.000 claims description 10
BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims description 9
239000011148 porous material Substances 0.000 claims description 7
239000007853 buffer solution Substances 0.000 claims description 6
241000283690 Bos taurus Species 0.000 claims description 5
230000004071 biological effect Effects 0.000 claims description 5
230000007717 exclusion Effects 0.000 claims description 5
238000004128 high performance liquid chromatography Methods 0.000 claims description 5
230000005526 G1 to G0 transition Effects 0.000 claims description 4
108010051696 Growth Hormone Proteins 0.000 claims description 3
102000018997 Growth Hormone Human genes 0.000 claims description 3
238000011088 calibration curve Methods 0.000 claims description 3
238000012545 processing Methods 0.000 claims description 2
108010000521 Human Growth Hormone Proteins 0.000 claims 1
102000002265 Human Growth Hormone Human genes 0.000 claims 1
239000000854 Human Growth Hormone Substances 0.000 claims 1
206010033307 Overweight Diseases 0.000 claims 1
230000002596 correlated effect Effects 0.000 claims 1
229960004532 somatropin Drugs 0.000 claims 1
235000018102 proteins Nutrition 0.000 description 41
239000012071 phase Substances 0.000 description 29
239000000523 sample Substances 0.000 description 21
230000000694 effects Effects 0.000 description 11
DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 7
238000000926 separation method Methods 0.000 description 7
239000012062 aqueous buffer Substances 0.000 description 6
238000010828 elution Methods 0.000 description 6
230000014759 maintenance of location Effects 0.000 description 5
XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 4
239000004202 carbamide Substances 0.000 description 4
238000005119 centrifugation Methods 0.000 description 4
238000004925 denaturation Methods 0.000 description 4
230000036425 denaturation Effects 0.000 description 4
239000000463 material Substances 0.000 description 4
150000003839 salts Chemical class 0.000 description 4
238000002211 ultraviolet spectrum Methods 0.000 description 4
HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
238000004587 chromatography analysis Methods 0.000 description 3
PJJJBBJSCAKJQF-UHFFFAOYSA-N guanidinium chloride Chemical compound [Cl-].NC(N)=[NH2+] PJJJBBJSCAKJQF-UHFFFAOYSA-N 0.000 description 3
238000012986 modification Methods 0.000 description 3
230000004048 modification Effects 0.000 description 3
239000000178 monomer Substances 0.000 description 3
238000011084 recovery Methods 0.000 description 3
239000007790 solid phase Substances 0.000 description 3
238000012360 testing method Methods 0.000 description 3
230000004584 weight gain Effects 0.000 description 3
235000019786 weight gain Nutrition 0.000 description 3
108020004511 Recombinant DNA Proteins 0.000 description 2
239000000872 buffer Substances 0.000 description 2
238000005516 engineering process Methods 0.000 description 2
229960000789 guanidine hydrochloride Drugs 0.000 description 2
238000012417 linear regression Methods 0.000 description 2
238000005259 measurement Methods 0.000 description 2
244000005700 microbiome Species 0.000 description 2
239000002244 precipitate Substances 0.000 description 2
238000004153 renaturation Methods 0.000 description 2
238000004007 reversed phase HPLC Methods 0.000 description 2
239000012488 sample solution Substances 0.000 description 2
230000003381 solubilizing effect Effects 0.000 description 2
239000003643 water by type Substances 0.000 description 2
IKOKHHBZFDFMJW-UHFFFAOYSA-N 2-[4-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]-3-(2-morpholin-4-ylethoxy)pyrazol-1-yl]-1-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)ethanone Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)C=1C(=NN(C=1)CC(=O)N1CC2=C(CC1)NN=N2)OCCN1CCOCC1 IKOKHHBZFDFMJW-UHFFFAOYSA-N 0.000 description 1
241000894006 Bacteria Species 0.000 description 1
BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 description 1
241000588724 Escherichia coli Species 0.000 description 1
206010062767 Hypophysitis Diseases 0.000 description 1
239000012901 Milli-Q water Substances 0.000 description 1
239000004721 Polyphenylene oxide Substances 0.000 description 1
102000009843 Thyroglobulin Human genes 0.000 description 1
108010034949 Thyroglobulin Proteins 0.000 description 1
238000010521 absorption reaction Methods 0.000 description 1
230000002378 acidificating effect Effects 0.000 description 1
230000002776 aggregation Effects 0.000 description 1
238000004220 aggregation Methods 0.000 description 1
230000004075 alteration Effects 0.000 description 1
150000001413 amino acids Chemical class 0.000 description 1
238000004458 analytical method Methods 0.000 description 1
-1 aromatic amino acid Chemical class 0.000 description 1
230000009286 beneficial effect Effects 0.000 description 1
230000000975 bioactive effect Effects 0.000 description 1
238000004166 bioassay Methods 0.000 description 1
238000003353 bioavailability assay Methods 0.000 description 1
BVKZGUZCCUSVTD-UHFFFAOYSA-N carbonic acid Chemical class OC(O)=O BVKZGUZCCUSVTD-UHFFFAOYSA-N 0.000 description 1
230000008859 change Effects 0.000 description 1
238000012512 characterization method Methods 0.000 description 1
239000003153 chemical reaction reagent Substances 0.000 description 1
239000003795 chemical substances by application Substances 0.000 description 1
239000000084 colloidal system Substances 0.000 description 1
150000001875 compounds Chemical class 0.000 description 1
230000007423 decrease Effects 0.000 description 1
230000003247 decreasing effect Effects 0.000 description 1
239000003398 denaturant Substances 0.000 description 1
239000003599 detergent Substances 0.000 description 1
238000004090 dissolution Methods 0.000 description 1
238000002474 experimental method Methods 0.000 description 1
239000012467 final product Substances 0.000 description 1
239000010931 gold Substances 0.000 description 1
229910052737 gold Inorganic materials 0.000 description 1
239000008187 granular material Substances 0.000 description 1
239000000122 growth hormone Substances 0.000 description 1
229960004198 guanidine Drugs 0.000 description 1
229940088597 hormone Drugs 0.000 description 1
239000005556 hormone Substances 0.000 description 1
239000012535 impurity Substances 0.000 description 1
210000003000 inclusion body Anatomy 0.000 description 1
238000002347 injection Methods 0.000 description 1
239000007924 injection Substances 0.000 description 1
238000002955 isolation Methods 0.000 description 1
239000000203 mixture Substances 0.000 description 1
239000003960 organic solvent Substances 0.000 description 1
210000003635 pituitary gland Anatomy 0.000 description 1
229920000570 polyether Polymers 0.000 description 1
229920001184 polypeptide Polymers 0.000 description 1
238000001556 precipitation Methods 0.000 description 1
238000002360 preparation method Methods 0.000 description 1
102000004196 processed proteins & peptides Human genes 0.000 description 1
108090000765 processed proteins & peptides Proteins 0.000 description 1
235000004252 protein component Nutrition 0.000 description 1
238000000746 purification Methods 0.000 description 1
238000003908 quality control method Methods 0.000 description 1
239000013558 reference substance Substances 0.000 description 1
230000000717 retained effect Effects 0.000 description 1
238000009666 routine test Methods 0.000 description 1
238000009938 salting Methods 0.000 description 1
239000002904 solvent Substances 0.000 description 1
229960000364 sometribove Drugs 0.000 description 1
108010057234 sometribove Proteins 0.000 description 1
229950002069 somidobove Drugs 0.000 description 1
239000010421 standard material Substances 0.000 description 1
239000011550 stock solution Substances 0.000 description 1
239000000126 substance Substances 0.000 description 1
239000006228 supernatant Substances 0.000 description 1
238000010998 test method Methods 0.000 description 1
229960002175 thyroglobulin Drugs 0.000 description 1
238000000108 ultra-filtration Methods 0.000 description 1
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1

Classifications

- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/61—Growth hormone [GH], i.e. somatotropin
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/22—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising organic material
- B01J20/26—Synthetic macromolecular compounds
- B01J20/262—Synthetic macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. obtained by polycondensation
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/22—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising organic material
- B01J20/26—Synthetic macromolecular compounds
- B01J20/265—Synthetic macromolecular compounds modified or post-treated polymers
- B01J20/267—Cross-linked polymers
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/28—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties
- B01J20/28002—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof characterised by their form or physical properties characterised by their physical properties
- B01J20/28004—Sorbent size or size distribution, e.g. particle size
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
- B01J20/282—Porous sorbents
- B01J20/285—Porous sorbents based on polymers
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
- B01J20/291—Gel sorbents
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/50—Conditioning of the sorbent material or stationary liquid
- G01N30/52—Physical parameters
- G01N2030/524—Physical parameters structural properties
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
- G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
- G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography

Landscapes

Chemical & Material Sciences (AREA)
Health & Medical Sciences (AREA)
Organic Chemistry (AREA)
Analytical Chemistry (AREA)
Life Sciences & Earth Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Endocrinology (AREA)
General Health & Medical Sciences (AREA)
Biochemistry (AREA)
Molecular Biology (AREA)
Genetics & Genomics (AREA)
Medicinal Chemistry (AREA)
Biophysics (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Gastroenterology & Hepatology (AREA)
Zoology (AREA)
Toxicology (AREA)
General Physics & Mathematics (AREA)
Physics & Mathematics (AREA)
Immunology (AREA)
Pathology (AREA)
Dispersion Chemistry (AREA)
Peptides Or Proteins (AREA)
Investigating Or Analysing Biological Materials (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

HU9502233A 1993-01-26 1994-01-24 Non-denaturing potency assay for bovine somatotropin HUT75678A (en)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
US903493A	1993-01-26	1993-01-26

Publications (2)

Publication Number	Publication Date
HU9502233D0 HU9502233D0 (en)	1995-09-28
HUT75678A true HUT75678A (en)	1997-05-28

Family

ID=21735207

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
HU9502233A HUT75678A (en)	1993-01-26	1994-01-24	Non-denaturing potency assay for bovine somatotropin

Country Status (13)

Country	Link
EP (1)	EP0681696A1 (da)
JP (1)	JPH08509288A (da)
KR (1)	KR960700454A (da)
CN (1)	CN1119042A (da)
AU (1)	AU6094794A (da)
BR (1)	BR9405672A (da)
CA (1)	CA2154794A1 (da)
CZ (1)	CZ193595A3 (da)
HU (1)	HUT75678A (da)
NO (1)	NO952948L (da)
PL (1)	PL310053A1 (da)
WO (1)	WO1994017403A1 (da)
ZA (1)	ZA94169B (da)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US5567620A (en) *	1993-01-26	1996-10-22	Eli Lilly And Company	Non-denaturing potency assay for somatotropin
CN120685920A (zh) *	2025-06-20	2025-09-23	浙江毓昌生物技术有限公司	一种牛生长激素体外相对生物活性检测方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US4511502A (en) *	1982-12-22	1985-04-16	Genentech, Inc.	Purification and activity assurance of precipitated heterologous proteins
BG49718A3 (bg) *	1983-07-15	1992-01-15	Bio- Technology General Corp	Метод за получаване на полипептид със супероксиддисмутазна активност
US5079230A (en) *	1988-09-12	1992-01-07	Pitman-Moore, Inc.	Stable bioactive somatotropins
US5064943A (en) *	1988-12-16	1991-11-12	American Cyanamid Company	Method for solubilization and naturation of somatotropin
US4975529A (en) *	1989-08-18	1990-12-04	Monsanto Company	Method of folding somatotropins
US5047511A (en) *	1989-08-28	1991-09-10	Pitman-Moore, Inc.	Method for recovering recombinant proteins

1994
- 1994-01-11 ZA ZA94169A patent/ZA94169B/xx unknown
- 1994-01-24 BR BR9405672A patent/BR9405672A/pt not_active Application Discontinuation
- 1994-01-24 CN CN94191402A patent/CN1119042A/zh active Pending
- 1994-01-24 AU AU60947/94A patent/AU6094794A/en not_active Abandoned
- 1994-01-24 EP EP94907307A patent/EP0681696A1/en not_active Withdrawn
- 1994-01-24 JP JP6517256A patent/JPH08509288A/ja active Pending
- 1994-01-24 PL PL94310053A patent/PL310053A1/xx unknown
- 1994-01-24 HU HU9502233A patent/HUT75678A/hu unknown
- 1994-01-24 CZ CZ951935A patent/CZ193595A3/cs unknown
- 1994-01-24 WO PCT/US1994/000850 patent/WO1994017403A1/en not_active Ceased
- 1994-01-24 CA CA002154794A patent/CA2154794A1/en not_active Abandoned
- 1994-01-24 KR KR1019950703075A patent/KR960700454A/ko not_active Withdrawn
1995
- 1995-07-25 NO NO952948A patent/NO952948L/no unknown

Also Published As

Publication number	Publication date
HU9502233D0 (en)	1995-09-28
CN1119042A (zh)	1996-03-20
JPH08509288A (ja)	1996-10-01
CA2154794A1 (en)	1994-01-24
NO952948D0 (no)	1995-07-25
NO952948L (no)	1995-09-18
PL310053A1 (en)	1995-11-13
EP0681696A4 (da)	1995-11-22
AU6094794A (en)	1994-08-15
EP0681696A1 (en)	1995-11-15
KR960700454A (ko)	1996-01-20
CZ193595A3 (en)	1996-05-15
WO1994017403A1 (en)	1994-08-04
BR9405672A (pt)	1995-11-14
ZA94169B (en)	1994-09-07

Legal Events

Date	Code	Title	Description
1998-03-02	DFD9	Temporary protection cancelled due to non-payment of fee

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