BRPI0917840B1 - Processo para redução da contaminação viral e microbiana de extratos biológicos, que contêm sólidos, e uso de um extrato biológico - Google Patents

Processo para redução da contaminação viral e microbiana de extratos biológicos, que contêm sólidos, e uso de um extrato biológico Download PDF

Info

Publication number
BRPI0917840B1
BRPI0917840B1 BRPI0917840-6A BRPI0917840A BRPI0917840B1 BR PI0917840 B1 BRPI0917840 B1 BR PI0917840B1 BR PI0917840 A BRPI0917840 A BR PI0917840A BR PI0917840 B1 BRPI0917840 B1 BR PI0917840B1
Authority
BR
Brazil
Prior art keywords
high pressure
pressure treatment
biological
extract
biological extract
Prior art date
Application number
BRPI0917840-6A
Other languages
English (en)
Portuguese (pt)
Inventor
Christian Rämsch
Thomas Schräder
Manfred Kurfürst
Thomas Moest
Original Assignee
Nordmark Arzneimittel Gmbh & Co. Kg
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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41110856&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0917840(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Nordmark Arzneimittel Gmbh & Co. Kg filed Critical Nordmark Arzneimittel Gmbh & Co. Kg
Publication of BRPI0917840A2 publication Critical patent/BRPI0917840A2/pt
Publication of BRPI0917840B1 publication Critical patent/BRPI0917840B1/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/94—Pancreatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
BRPI0917840-6A 2008-08-27 2009-08-27 Processo para redução da contaminação viral e microbiana de extratos biológicos, que contêm sólidos, e uso de um extrato biológico BRPI0917840B1 (pt)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
DE102008039860 2008-08-27
DE102008039860.8 2008-08-27
EP09007797.5 2009-06-12
EP09007797A EP2165717A1 (de) 2008-08-27 2009-06-12 Verfahren zur Verringerung der viralen und mikrobiellen Belastung feststoffhaltiger biologischer Extrakte
PCT/EP2009/004318 WO2010022808A1 (de) 2008-08-27 2009-06-16 Verfahren zur verringerung der viralen und mikrobiellen belastung feststoffhaltiger biologischer extrakte
EPPCT/EP2009/004318 2009-06-16
PCT/EP2009/006216 WO2010022946A1 (de) 2008-08-27 2009-08-27 Verfahren zur verringerung der viralen und mikrobiellen belastung feststoffhaltiger biologischer extrakte

Publications (2)

Publication Number Publication Date
BRPI0917840A2 BRPI0917840A2 (pt) 2015-08-11
BRPI0917840B1 true BRPI0917840B1 (pt) 2018-08-14

Family

ID=41110856

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0917840-6A BRPI0917840B1 (pt) 2008-08-27 2009-08-27 Processo para redução da contaminação viral e microbiana de extratos biológicos, que contêm sólidos, e uso de um extrato biológico

Country Status (7)

Country Link
US (1) US9107966B2 (https=)
EP (2) EP2165717A1 (https=)
JP (2) JP2012500636A (https=)
BR (1) BRPI0917840B1 (https=)
ES (1) ES2532637T3 (https=)
PL (1) PL2328623T3 (https=)
WO (2) WO2010022808A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2165717A1 (de) 2008-08-27 2010-03-24 Nordmark Arzneimittel GmbH & Co.KG Verfahren zur Verringerung der viralen und mikrobiellen Belastung feststoffhaltiger biologischer Extrakte
ES2488407T3 (es) 2009-01-29 2014-08-27 Nordmark Arzneimittel Gmbh & Co. Kg Preparación farmacéutica que contiene lipasa de origen bacteriano
PL2295039T5 (pl) * 2009-08-28 2023-02-27 Nordmark Pharma Gmbh Sposób wytwarzania granulek zawierających pankreatynę, w szczególności mikrogranulek zawierających pankreatynę, oraz wytworzone tym sposobem granulki zawierające pankreatynę
EP2489349B1 (de) 2011-02-17 2014-05-28 Nordmark Arzneimittel GmbH & Co.KG Pankreatin-Pellets, insbesondere Pankreatin-Mikropellets, und Verfahren zu deren Herstellung
MX380367B (es) 2015-05-19 2025-03-12 Scient Protein Laboratories Llc Metodo para reducir o inactivar contenido viral o microbiano en los procesos para la fabricacion de pancreatina.
DE102015119006A1 (de) 2015-11-05 2017-05-11 Nordmark Arzneimittel Gmbh & Co. Kg Verfahren zur Reduzierung der Belastung von Pankreatin mit Mikroorganismen
CN108795920B (zh) * 2018-06-22 2022-04-08 苏州良辰生物医药科技有限公司 一种胰酶的制备方法

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA394981A (en) * 1941-03-04 The Griffith Laboratories Pancreatin sterilization
US2189948A (en) * 1938-10-31 1940-02-13 Griffith Laboratories Sterilization of pancreatin
US3493399A (en) 1967-04-11 1970-02-03 Ezra Levin Pancreatic food product
DE2923279C2 (de) 1979-06-08 1987-07-09 Kali-Chemie Pharma Gmbh, 3000 Hannover Verfahren zur Herstellung von Pankreatin-Pellets und diese enthaltende Arzneimittel
DE3377506D1 (en) 1982-12-30 1988-09-01 Nordmark Arzneimittel Gmbh Process for obtaining pancreatin
DE3248588A1 (de) 1982-12-30 1984-07-12 Nordmark-Werke Gmbh, 2000 Hamburg Verfahren zur gewinnung von pankreatin von hohem schuettgewicht
CA2030581C (en) 1989-11-24 2000-06-27 Gunther Atzl Pancreatin preparations
DE4227385A1 (de) 1992-08-19 1994-02-24 Kali Chemie Pharma Gmbh Pankreatinmikropellets
US6696019B2 (en) † 1998-06-15 2004-02-24 Bbi Bioseq, Inc. Rapid cryobaric sterilization and vaccine preparation
US6270723B1 (en) * 1998-06-15 2001-08-07 Bbi Bioseq, Inc. Rapid cryobaric sterilization and vaccine preparation
FR2804326B1 (fr) * 2000-01-27 2002-10-18 Ellipse Pharmaceuticals Procede de sterilisation par traitement sous hautes pressions de principes actifs sensibles
WO2002056824A2 (en) 2000-08-10 2002-07-25 Boston Biomedica, Inc. Pressure cycling inactivation of pathogens in biological materials used for therapeutics or vaccines
CA2560613C (en) 2004-03-22 2015-11-24 Solvay Pharmaceuticals Gmbh Oral pharmaceutical compositions of lipase-containing products, in particular of pancreatin, containing surfactants
WO2006044529A1 (en) 2004-10-14 2006-04-27 Altus Pharmaceuticals Inc. Compositions containing lipase; protease and amylase for treating pancreatic insufficiency
KR101555058B1 (ko) * 2005-07-29 2015-09-22 애보트 래버러토리즈 게엠베하 살균된 판크레아틴 분말의 제조방법
US11266607B2 (en) 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
WO2008127567A1 (en) 2007-04-13 2008-10-23 Beth Israel Deaconess Medical Center, Inc. Novel nutritional food products for improved digestion and intestinal absorption
EP2165717A1 (de) 2008-08-27 2010-03-24 Nordmark Arzneimittel GmbH & Co.KG Verfahren zur Verringerung der viralen und mikrobiellen Belastung feststoffhaltiger biologischer Extrakte
ES2488407T3 (es) 2009-01-29 2014-08-27 Nordmark Arzneimittel Gmbh & Co. Kg Preparación farmacéutica que contiene lipasa de origen bacteriano
PL2295039T5 (pl) 2009-08-28 2023-02-27 Nordmark Pharma Gmbh Sposób wytwarzania granulek zawierających pankreatynę, w szczególności mikrogranulek zawierających pankreatynę, oraz wytworzone tym sposobem granulki zawierające pankreatynę
EP2489349B1 (de) 2011-02-17 2014-05-28 Nordmark Arzneimittel GmbH & Co.KG Pankreatin-Pellets, insbesondere Pankreatin-Mikropellets, und Verfahren zu deren Herstellung

Also Published As

Publication number Publication date
WO2010022808A1 (de) 2010-03-04
JP6109881B2 (ja) 2017-04-05
EP2328623B1 (de) 2014-12-24
JP2015198670A (ja) 2015-11-12
JP2012500636A (ja) 2012-01-12
US9107966B2 (en) 2015-08-18
WO2010022946A1 (de) 2010-03-04
PL2328623T3 (pl) 2015-08-31
US20110268844A1 (en) 2011-11-03
EP2328623A1 (de) 2011-06-08
ES2532637T3 (es) 2015-03-30
EP2328623B2 (de) 2024-04-03
EP2165717A1 (de) 2010-03-24
BRPI0917840A2 (pt) 2015-08-11

Similar Documents

Publication Publication Date Title
ES2385958T3 (es) Procedimiento para reducir la carga viral y microbiana de pancreatina
BRPI0917840B1 (pt) Processo para redução da contaminação viral e microbiana de extratos biológicos, que contêm sólidos, e uso de um extrato biológico
US5342752A (en) Method of inactivation of viral blood contaminants using acridine deriatives
RU2413532C2 (ru) Способ получения стерилизованного порошкообразного панкреатина
CN101613394B (zh) 鼠神经生长因子的制备方法和注射用鼠神经生长因子的制备方法
CN112028980B (zh) 丝胶蛋白、提取方法、作为细胞抗病毒免疫增强剂和应用
CN101757651B (zh) 一种动物纤维蛋白原病毒灭活方法
US20100119654A1 (en) Method for reducing the virus and micro-organism content of biological extracts which contain solids and extract produced according to the method
JPS59130819A (ja) 血しようタンパク製品の溶媒処理法
JP2004105740A (ja) タンパクを含む生物学的組成物の滅菌プロセス
CN101757616B (zh) 一种安全的冻干哺乳动物源凝血酶制剂及其制备方法
CN1302009C (zh) 用有机溶剂病毒灭活法制备鼠神经生长因子的工艺
EP2087897A1 (en) Method for producing apyrogenic immunomodulator
CN118064419A (zh) 一种去除病毒制备胰酶的方法
KR102511149B1 (ko) E-빔을 이용한 봉독 멸균 공정 및 a형 간염 바이러스를 이용한 멸균 공정의 검증
KR102511147B1 (ko) E-빔을 이용한 봉독 멸균 공정 및 모델 바이러스를 이용한 멸균 공정의 검증
KR102511148B1 (ko) E-빔을 이용한 봉독 멸균 공정 및 돼지 파보바이러스를 이용한 멸균 공정의 검증
CN101759766B (zh) 一种动物源可凝固蛋白的制备方法
EP1400248A1 (en) Process for sterilization of protein containing biological compositions
CN116747326A (zh) 一种紫外线照射灭活血浆中病毒的方法
CN116440223A (zh) 一种灭活sars病毒的溶毒仿生酶及其制备方法
CN110885814A (zh) 一种在制备饲料级胰酶中的灭活病毒的方法
BR112017024920B1 (pt) Método de fabricação de uma preparação de pancreatina
JPH02289253A (ja) 天然物質中の外被のないウイルスの不活性化用組成物及びその製造方法
DE102009038758A1 (de) Verfahren zur Verringerung der viralen und mikrobiellen Belastung feststoffhaltiger biologischer Extrakte

Legal Events

Date Code Title Description
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]
B25D Requested change of name of applicant approved

Owner name: NORDMARK ARZNEIMITTEL HOLDING GMBH AND CO. KG (DE)

B25A Requested transfer of rights approved

Owner name: NORDMARK PHARMA GMBH (DE)

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 16A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2846 DE 22-07-2025 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.