JP6389170B2 - ペプチド溶液のためのフィル−フィニッシュ過程 - Google Patents
ペプチド溶液のためのフィル−フィニッシュ過程 Download PDFInfo
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- JP6389170B2 JP6389170B2 JP2015520684A JP2015520684A JP6389170B2 JP 6389170 B2 JP6389170 B2 JP 6389170B2 JP 2015520684 A JP2015520684 A JP 2015520684A JP 2015520684 A JP2015520684 A JP 2015520684A JP 6389170 B2 JP6389170 B2 JP 6389170B2
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/12—Sterilising contents prior to, or during, packaging
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B63/00—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/04—Linear peptides containing only normal peptide links
- C07K7/08—Linear peptides containing only normal peptide links having 12 to 20 amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K5/00—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof
- C07K5/04—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing only normal peptide links
- C07K5/10—Tetrapeptides
- C07K5/1002—Tetrapeptides with the first amino acid being neutral
- C07K5/1005—Tetrapeptides with the first amino acid being neutral and aliphatic
- C07K5/101—Tetrapeptides with the first amino acid being neutral and aliphatic the side chain containing 2 to 4 carbon atoms, e.g. Val, Ile, Leu
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K5/00—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof
- C07K5/04—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing only normal peptide links
- C07K5/10—Tetrapeptides
- C07K5/1019—Tetrapeptides with the first amino acid being basic
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Water Supply & Treatment (AREA)
- Peptides Or Proteins (AREA)
- Degasification And Air Bubble Elimination (AREA)
- Physical Water Treatments (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
Description
本明細書は、2013年7月3日に「2004837−0032_Sequences_ST25」に指定されたASCII.txtファイルとして電子書式で提出された配列表に言及する。txtファイルは、2013年6月10日に作成され、11KBのサイズである。
定義
自己集合性ペプチド
*これらのペプチドは、NaClを含有する溶液中でインキュベートされるとき、βシートを形成するが、それらは、巨視的骨格を形成するように自己集合することが観察されていない。
溶解
第1の脱気
濾過
第2の脱気
充填
洗浄装置
実施例
自己集合性ペプチド溶液の例示的な生成検証
Claims (28)
- 0.01MPa/分以下の速度で、および/または、ペプチド溶液の大きい表面積が空気と接触する条件下で、圧力を低下させることによって、水溶液中の自己集合性ペプチドを含む混合物が脱気される、第1の脱気工程と、
滅菌フィルタを通して前記混合物を濾過する工程と、
滅菌条件下で、振動、および圧力を低下させることによって、前記濾液が脱気される、第2の脱気工程と、
を含む、
均一に混合された、滅菌溶液を得るための方法。 - 前記滅菌フィルタは、0.22μm未満の平均細孔径を有する、請求項1に記載の方法。
- 前記自己集合性ペプチドは、RADA16−I(配列番号1)を含む、請求項1に記載の方法。
- 前記自己集合性ペプチドは、IEIK13(配列番号39)を含む、請求項1に記載の方法。
- 前記第1の脱気工程は、0.01MPa/分未満の速度で、前記混合物の前記圧力を低下させることを含む、請求項1に記載の方法。
- 前記第1および/または第2の脱気工程は、少なくとも0.095MPa、前記圧力を低下させることを含む、請求項1に記載の方法。
- 前記圧力を低下させた後、前記圧力が少なくとも30分間維持される、請求項6に記載の方法。
- 前記第2の脱気工程は、150回転/分で前記混合物を振動させることを含み、前記振動運動の偏心距離は、−10cm〜10cmの間である、請求項1に記載の方法。
- 前記第1の脱気工程の前に、前記ペプチドを溶媒と混合することをさらに含む、請求項1に記載の方法。
- 前記溶媒は水である、請求項9に記載の方法。
- 前記第2の脱気工程の後に、前記混合物で物品を無菌充填することをさらに含む、請求項1に記載の方法。
- 前記物品は、前記第2の脱気工程の少なくとも5時間後に充填される、請求項11に記載の方法。
- 前記物品は、注射器、パウチ、バイアル、チューブである、請求項11に記載の方法。
- 前記充填工程後に、ガス透過性材料で充填された物品を包装することと、滅菌工程とをさらに含む、請求項11に記載の方法。
- ガス滅菌は、エチレンオキサイドガスまたは過酸化水素ガスによって実施される、請求項14に記載の方法。
- 前記物品を包装することは、単一包装または二重包装で実施される、請求項14に記載の方法。
- 前記濾過は、0.5MPaの圧力で実施される、請求項1に記載の方法。
- 前記濾過は、周囲温度前後で実施される、請求項17に記載の方法。
- 前記フィルタは、以下:セルロースナイトレート、セルロースアセテート、ビニルポリマー、フッ化炭素、ポリエチレン、超高分子量ポリエチレン、ポリプロピレン、EVAコポリマーおよびαオレフィン、メタロセンオレフィンポリマー、PFA、MFA、PTFE、ポリカーボネート、ビニルコポリマー、ポリアミド、ナイロン、ポリエステル、セルロース、セルロースアセテート、再生セルロース、セルロース複合体、ポリスルホン、ポリエーテルスルホン、ポリアリルスルホン、ポリフェニルスルホン、ポリアクリロニトリル、ポリビニリデンフルオライド(PVDF)、およびそれらのブレンドからなる群より選択される材料から構成される、請求項1に記載の方法。
- 前記フィルタは、ポリエーテルスルホンから構成される、請求項1に記載の方法。
- 前記濾過工程は、第1の圧力で前記フィルタを充填し、次いで、前記濾過を実施するために前記圧力を上昇させる工程を含む、請求項1に記載の方法。
- 前記フィルタは、完全性試験の前に洗浄される、請求項1に記載の方法。
- 前記フィルタは、完全性試験の前に水で洗浄され、任意に、前記フィルタは、温水および/または高圧水で洗浄される、請求項22に記載の方法。
- 前記濾過を実施するための圧力源として前記圧力を保持するために、圧力源と濾過供給タンクとの間に追加のタンクが配置される、請求項1に記載の方法。
- スクレーパが、濾過供給タンクからフィルタにほぼ全ての前記溶液を供給するために使用される、請求項1に記載の方法。
- 前記濾過工程は、濾過を補助するためのピグの使用を含む、請求項1に記載の方法。
- 前記濾過工程は、並列に動作される2つのフィルタで実施される、請求項1に記載の方法。
- 蒸気を前記濾過および脱気装置に添加することを含む、洗浄工程をさらに含む、請求項1に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261668688P | 2012-07-06 | 2012-07-06 | |
US61/668,688 | 2012-07-06 | ||
PCT/US2013/049327 WO2014008400A2 (en) | 2012-07-06 | 2013-07-03 | Fill-finish process for peptide solutions |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2015530970A JP2015530970A (ja) | 2015-10-29 |
JP2015530970A5 JP2015530970A5 (ja) | 2016-09-01 |
JP6389170B2 true JP6389170B2 (ja) | 2018-09-12 |
Family
ID=49882610
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015520684A Active JP6389170B2 (ja) | 2012-07-06 | 2013-07-03 | ペプチド溶液のためのフィル−フィニッシュ過程 |
Country Status (7)
Country | Link |
---|---|
US (3) | US10793307B2 (ja) |
EP (2) | EP2869903B1 (ja) |
JP (1) | JP6389170B2 (ja) |
CN (1) | CN104902974B (ja) |
AU (1) | AU2013286676B2 (ja) |
ES (1) | ES2706065T3 (ja) |
WO (1) | WO2014008400A2 (ja) |
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2013
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US20210024236A1 (en) | 2021-01-28 |
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WO2014008400A2 (en) | 2014-01-09 |
EP2869903B1 (en) | 2018-11-28 |
WO2014008400A3 (en) | 2015-07-16 |
EP2869903A2 (en) | 2015-05-13 |
US20220258900A9 (en) | 2022-08-18 |
EP3466964A1 (en) | 2019-04-10 |
AU2013286676A1 (en) | 2015-02-26 |
CN104902974B (zh) | 2017-07-28 |
ES2706065T3 (es) | 2019-03-27 |
CN104902974A (zh) | 2015-09-09 |
JP2015530970A (ja) | 2015-10-29 |
US20150197359A1 (en) | 2015-07-16 |
US12006085B2 (en) | 2024-06-11 |
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