PL3298139T3 - Sposób zmniejszenia lub inaktywacji zawartości wirusów i drobnoustrojów w sposobach wytwarzania pankreatyny - Google Patents

Sposób zmniejszenia lub inaktywacji zawartości wirusów i drobnoustrojów w sposobach wytwarzania pankreatyny

Info

Publication number
PL3298139T3
PL3298139T3 PL16797318T PL16797318T PL3298139T3 PL 3298139 T3 PL3298139 T3 PL 3298139T3 PL 16797318 T PL16797318 T PL 16797318T PL 16797318 T PL16797318 T PL 16797318T PL 3298139 T3 PL3298139 T3 PL 3298139T3
Authority
PL
Poland
Prior art keywords
pancreatin
manufacture
processes
reducing
microbial content
Prior art date
Application number
PL16797318T
Other languages
English (en)
Inventor
Kenneth S. MANNING
Dustin Nielsen
Ryan RUF
Colin Crowley
Jon RESTIVO
Dana SPANGENBERG
Karla ANHALT
Mark ROMICH
Anisha Akula
Carmen FRITZ
Yan Wang
Original Assignee
Scientific Protein Laboratories Llc
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
Application filed by Scientific Protein Laboratories Llc filed Critical Scientific Protein Laboratories Llc
Publication of PL3298139T3 publication Critical patent/PL3298139T3/pl

Links

Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/327—Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37—Digestive system
    • A61K35/39—Pancreas; Islets of Langerhans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • 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
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • 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
    • C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011—Details
    • C12N2750/10011—Circoviridae
    • C12N2750/10061—Methods of inactivation or attenuation
    • C12N2750/10063—Methods of inactivation or attenuation by chemical treatment
    • 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
    • C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011—Details
    • C12N2750/14011—Parvoviridae
    • C12N2750/14311—Parvovirus, e.g. minute virus of mice
    • C12N2750/14361—Methods of inactivation or attenuation
    • C12N2750/14363—Methods of inactivation or attenuation by chemical treatment
    • 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
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/32011—Picornaviridae
    • C12N2770/32211—Cardiovirus, e.g. encephalomyocarditis virus
    • C12N2770/32261—Methods of inactivation or attenuation
    • C12N2770/32263—Methods of inactivation or attenuation by chemical treatment

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Developmental Biology & Embryology (AREA)
  • Physiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)
PL16797318T 2015-05-19 2016-05-19 Sposób zmniejszenia lub inaktywacji zawartości wirusów i drobnoustrojów w sposobach wytwarzania pankreatyny PL3298139T3 (pl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562163779P 2015-05-19 2015-05-19
EP16797318.9A EP3298139B1 (en) 2015-05-19 2016-05-19 Method for reducing or inactivating viral and microbial content in the processes for the manufacture of pancreatin
US15/159,345 US10093916B2 (en) 2015-05-19 2016-05-19 Method for reducing or inactivating viral and microbial content in the processes for the manufacture of pancreatin
PCT/US2016/033329 WO2016187455A1 (en) 2015-05-19 2016-05-19 Method for reducing or inactivating viral and microbial content in the processes for the manufacture of pancreatin

Publications (1)

Publication Number Publication Date
PL3298139T3 true PL3298139T3 (pl) 2022-01-31

Family

ID=57320830

Family Applications (1)

Application Number Title Priority Date Filing Date
PL16797318T PL3298139T3 (pl) 2015-05-19 2016-05-19 Sposób zmniejszenia lub inaktywacji zawartości wirusów i drobnoustrojów w sposobach wytwarzania pankreatyny

Country Status (7)

Country Link
US (2) US10093916B2 (pl)
EP (1) EP3298139B1 (pl)
CN (2) CN107849552B (pl)
CY (1) CY1124679T1 (pl)
MX (1) MX380367B (pl)
PL (1) PL3298139T3 (pl)
WO (1) WO2016187455A1 (pl)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107849552B (zh) * 2015-05-19 2021-11-02 科学蛋白实验室有限责任公司 在生产胰液素过程中减少或灭活病毒和微生物内容物的方法
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
CN109810968B (zh) * 2019-03-13 2021-03-02 淮安麦德森制药有限公司 胰酶的制备方法
CN112708611A (zh) * 2021-01-19 2021-04-27 四川菲德力制药有限公司 一种胰酶制备方法

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3956483A (en) 1968-10-24 1976-05-11 Wilson Pharmaceutical & Chemical Corporation Preparing pancreatin
US4986963A (en) 1989-01-24 1991-01-22 Corcoran Richard A Method of disinfecting contact lenses with peracetic acid
US20020192731A1 (en) * 2001-04-12 2002-12-19 H. Shih Jason C. Method and composition for sterilizing surgical instruments
US6749851B2 (en) 2001-08-31 2004-06-15 Clearant, Inc. Methods for sterilizing preparations of digestive enzymes
AU2003278929A1 (en) * 2002-10-18 2004-05-13 Amylin Pharmaceuticals, Inc. Treatment of pancreatitis with amylin
RU2413532C2 (ru) * 2005-07-29 2011-03-10 Зольвай Фармасьютиклз Гмбх Способ получения стерилизованного порошкообразного панкреатина
KR101562682B1 (ko) * 2007-11-15 2015-10-22 애보트 래버러토리즈 게엠베하 판크레아틴 샘플내의 바이러스 로드의 분리 및 정량을 위한 신규방법
US20090130063A1 (en) * 2007-11-15 2009-05-21 Solvay Pharmaceuticals Gmbh Process for separating and determining the viral load in a pancreatin sample
EP2165717A1 (de) 2008-08-27 2010-03-24 Nordmark Arzneimittel GmbH & Co.KG Verfahren zur Verringerung der viralen und mikrobiellen Belastung feststoffhaltiger biologischer Extrakte
PL2295086T3 (pl) 2008-11-03 2012-09-28 Nordmark Arzneimittel Gmbh & Co Kg Sposób zmniejszania skażenia pankreatyny wirusami i drobnoustrojami
RU2012106760A (ru) * 2009-07-21 2013-08-27 Трансген Са Ферментативная композиция для ферментативного расщепления куриного эмбриона
US9511125B2 (en) * 2009-10-21 2016-12-06 Curemark Llc Methods and compositions for the treatment of influenza
CN102762720B (zh) 2009-11-12 2015-03-11 Vbi技术有限责任公司 类孢子细胞子群及其用途
CN102884181A (zh) * 2010-03-19 2013-01-16 加拿大阿普塔利斯制药公司 用于药用胰腺酶制剂中的病毒灭活的β-丙内酯
CN107849552B (zh) * 2015-05-19 2021-11-02 科学蛋白实验室有限责任公司 在生产胰液素过程中减少或灭活病毒和微生物内容物的方法

Also Published As

Publication number Publication date
EP3298139A1 (en) 2018-03-28
CN113750224B (zh) 2024-04-30
MX380367B (es) 2025-03-12
MX2017014743A (es) 2018-01-26
CY1124679T1 (el) 2022-07-22
US20180362958A1 (en) 2018-12-20
CN113750224A (zh) 2021-12-07
CN107849552A (zh) 2018-03-27
WO2016187455A1 (en) 2016-11-24
EP3298139B1 (en) 2021-09-15
EP3298139A4 (en) 2019-02-06
US20170037392A1 (en) 2017-02-09
US11952603B2 (en) 2024-04-09
US10093916B2 (en) 2018-10-09
BR112017024920A2 (pt) 2018-07-31
CN107849552B (zh) 2021-11-02

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