JP2023002512A - 精製ヒトミルクオリゴ糖組成物 - Google Patents
精製ヒトミルクオリゴ糖組成物 Download PDFInfo
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- JP2023002512A JP2023002512A JP2022146600A JP2022146600A JP2023002512A JP 2023002512 A JP2023002512 A JP 2023002512A JP 2022146600 A JP2022146600 A JP 2022146600A JP 2022146600 A JP2022146600 A JP 2022146600A JP 2023002512 A JP2023002512 A JP 2023002512A
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- Prior art keywords
- hmo
- human milk
- permeate
- purified
- lactase
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Abstract
Description
本出願は、その内容全体が参照により本明細書に組み込まれる、2016年9月19日に出願された米国仮特許出願第62/396,799号に対する優先権を主張する。
精製HMO組成物を作製する方法
精製HMO組成物
精製HMO組成物の使用
実施例
代表的な試料を充填プロセスから採取した。各最終バルクロット充填には、1つのバイオバーデン試料のみが必要であった。実施例:1つの最終バルクロットを0.1x及び0.2xの目標用量に充填した場合、1つの試料のみを採取して、充填された0.1x及び0.2xの目標用量の両方を表した。これらの試験の結果は、表3に示される。
1結果が100CFU/mL以上である場合、例外的条件を開始し、追加の2つの試料が試験される。最終的に報告された結果は、3つの試料の平均である。
2結果が100CFU/mL以上である場合、例外的条件を開始し、追加の2つの試料が試験される。最終的に報告された結果は、3つの試料の平均である。
1.Bao Y,Zhu L,Newburg DS.Simultaneous quantification of sialyloligosaccharides from human milk by capillary electrophoresis.Anal Biochem.2007;370:206~214.
2.Bode,L.Human milk oligosaccharides:Every baby needs a sugar mama.Glycobiology.2012 Sep;22(9):1147~1162.2012年4月18日にオンラインで公開。
3.14.Bode,et al.(2016)Nutritional Reviews,74(10):635~644
4.Chaturvedi P,Warren CD,Altaye M,Morrow AL,Ruiz-Palacios G,Pickering LK,Newburg DS.Fucosylated human milk oligosaccharides vary between individuals and over the course of lactation.Glycobiology.2001;11:365~372.
5.Coppa GV,Pierani P,Zampini L,Carloni I,Carlucci A,Gabrielli O.Oligosaccharides in human milk during different phases of lactation.Acta Paediatr.1999;88:89~94.
6.Davidson B,Meinzen-Derr JK,Wagner CL,Newburg DS,Morrow AL.Fucosylated oligosaccharides in human milk in relation to gestational age and stage of lactation.Adv Exp Med Biol.2004;554:427~430.
7.Gabrielli O,Zampini L,Galeazzi T,Padella L,Santoro L,Peila C,Giuliani F,Bertino E,Fabris C,Coppa GV.Preterm milk oligosaccharides during the first month of lactation.Pediatrics.2011;128:e1520~1531.
8.German,JB et al.Nestle Nutr Workshop Ser Pediatr Program.2008.62:205~18.
9.Grandison,et al(2002)Songklanakarin J.Sci.Technol.24(Suppl):91~928.
10.Kunz C,Rudloff S,Baier W,Klein N,Strobel S.Oligosaccharides in human milk:Structural,functional,and metabolic aspects.Annu Rev Nutr.2000;20:699~722.
11.Kunz C,Rudloff S,Schad W,Braun D.Lactose-derived oligosaccharides in the milk of elephants:Comparison with human milk.Br J Nutr.1999;82:391~399.
12.Kunz et al.「Bioactivity of Human Milk Oligosaccharides」page 5 in Food Oligosaccharides:Production,Analysis and Bioactivity,First Edition.Dr.F.Javier Moreno and Dr.Maria Luz Sanz編集
13.Morrow Ruiz-Palacios GM,Jiang X,Newburg DS.,Human-milk glycans that inhibit pathogen binding protect breast-feeding infants against infectious diarrhea.J.Nutri.135:1304~07,2005.
14.Newburg DS,Shen Z,Warren CD.Quantitative analysis of human milk oligosaccharides by capillary electrophoresis.Adv Exp Med Biol.2000;478:381~382.
15.Sarney,et al(2000)Biotechnol.Bioeng.69:461~467
16.Thum,et al.(2015)J Food Comp and Anal.,42:30~37.
17.Ward(2009)Open Glycoscience 2:9~15
18.Zivkovic,et al(2011)Proc.Natl.Acad.Sci.,108(s1):4653~4658.
本出願は、その内容全体が参照により本明細書に組み込まれる、2016年9月19日に出願された米国仮特許出願第62/396,799号に対する優先権を主張する。
精製HMO組成物を作製する方法
精製HMO組成物
精製HMO組成物の使用
実施例
代表的な試料を充填プロセスから採取した。各最終バルクロット充填には、1つのバイオバーデン試料のみが必要であった。実施例:1つの最終バルクロットを0.1x及び0.2xの目標用量に充填した場合、1つの試料のみを採取して、充填された0.1x及び0.2xの目標用量の両方を表した。これらの試験の結果は、表3に示される。
1結果が100CFU/mL以上である場合、例外的条件を開始し、追加の2つの試料が試験される。最終的に報告された結果は、3つの試料の平均である。
2結果が100CFU/mL以上である場合、例外的条件を開始し、追加の2つの試料が試験される。最終的に報告された結果は、3つの試料の平均である。
1.Bao Y,Zhu L,Newburg DS.Simultaneous quantification of sialyloligosaccharides from human milk by capillary electrophoresis.Anal Biochem.2007;370:206~214.
2.Bode,L.Human milk oligosaccharides:Every baby needs a sugar mama.Glycobiology.2012 Sep;22(9):1147~1162.2012年4月18日にオンラインで公開。
3.14.Bode,et al.(2016)Nutritional Reviews,74(10):635~644
4.Chaturvedi P,Warren CD,Altaye M,Morrow AL,Ruiz-Palacios G,Pickering LK,Newburg DS.Fucosylated human milk oligosaccharides vary between individuals and over the course of lactation.Glycobiology.2001;11:365~372.
5.Coppa GV,Pierani P,Zampini L,Carloni I,Carlucci A,Gabrielli O.Oligosaccharides in human milk during different phases of lactation.Acta Paediatr.1999;88:89~94.
6.Davidson B,Meinzen-Derr JK,Wagner CL,Newburg DS,Morrow AL.Fucosylated oligosaccharides in human milk in relation to gestational age and stage of lactation.Adv Exp Med Biol.2004;554:427~430.
7.Gabrielli O,Zampini L,Galeazzi T,Padella L,Santoro L,Peila C,Giuliani F,Bertino E,Fabris C,Coppa GV.Preterm milk oligosaccharides during the first month of lactation.Pediatrics.2011;128:e1520~1531.
8.German,JB et al.Nestle Nutr Workshop Ser Pediatr Program.2008.62:205~18.
9.Grandison,et al(2002)Songklanakarin J.Sci.Technol.24(Suppl):91~928.
10.Kunz C,Rudloff S,Baier W,Klein N,Strobel S.Oligosaccharides in human milk:Structural,functional,and metabolic aspects.Annu Rev Nutr.2000;20:699~722.
11.Kunz C,Rudloff S,Schad W,Braun D.Lactose-derived oligosaccharides in the milk of elephants:Comparison with human milk.Br J Nutr.1999;82:391~399.
12.Kunz et al.「Bioactivity of Human Milk Oligosaccharides」page 5 in Food Oligosaccharides:Production,Analysis and Bioactivity,First Edition.Dr.F.Javier Moreno and Dr.Maria Luz Sanz編集
13.Morrow Ruiz-Palacios GM,Jiang X,Newburg DS.,Human-milk glycans that inhibit pathogen binding protect breast-feeding infants against infectious diarrhea.J.Nutri.135:1304~07,2005.
14.Newburg DS,Shen Z,Warren CD.Quantitative analysis of human milk oligosaccharides by capillary electrophoresis.Adv Exp Med Biol.2000;478:381~382.
15.Sarney,et al(2000)Biotechnol.Bioeng.69:461~467
16.Thum,et al.(2015)J Food Comp and Anal.,42:30~37.
17.Ward(2009)Open Glycoscience 2:9~15
18.Zivkovic,et al(2011)Proc.Natl.Acad.Sci.,108(s1):4653~4658.
Claims (22)
- 精製ヒトミルクオリゴ糖組成物を作製する方法であって、
(a)人乳透過液を、前記人乳透過液中のラクトースの消化に好適な条件下でラクターゼと混合して、透過液/ラクターゼ混合物を作り出すことと、
(b)前記透過液/ラクターゼ混合物から前記ラクターゼを除去することと、
(c)前記混合物を濾過して、ヒトミルクオリゴ糖を精製及び濃縮することと、を含む、方法。 - 前記透過液のpHが、前記ラクターゼの添加前又はそれと同時に、約4.3~約4.7のpHに調整される、請求項1に記載の方法。
- 前記pHが、前記ラクトースを添加する前に4.5に調整される、請求項2に記載の方法。
- 前記透過液が、前記ラクターゼの添加前又はそれと同時に、約45℃~約55℃の温度に加熱される、請求項1に記載の方法。
- 前記透過液が、前記ラクターゼを添加する前に約50℃に加熱される、請求項4に記載の方法。
- ラクターゼが、工程(iii)において約0.1%~約0.5%重量/重量で添加される、請求項1に記載の方法。
- ラクターゼが、約0.1%重量/重量で添加される、請求項6に記載の方法。
- 前記混合物を、ラクターゼの除去の前に約20℃~約30℃の温度に冷却することを更に含む、請求項1に記載の方法。
- 前記温度が、約25℃である、請求項8に記載の方法。
- デプスフィルタを通して前記ラクターゼ消化透過液を浄化することを更に含む、請求項1に記載の方法。
- 前記デプスフィルタが、約1~約5ミクロンのフィルタである、請求項10に記載の方法。
- 前記濾過が、約50,000ダルトンの孔径を有する膜を通して工程(b)の前記混合物を濾過して、50ダルトンの濾過混合物を作り出すことを含む、請求項1に記載の方法。
- 約2,000ダルトン~約3,000ダルトンの孔径を有する膜を通して前記50ダルトンの濾過混合物を濾過して、2/3ダルトンの濾過混合物を作り出すことを更に含む、請求項12に記載の方法。
- 600ダルトン以下の孔径を有する膜を通して、前記50ダルトンの濾過混合物又は前記2/3ダルトンの濾過混合物を濾過することを更に含む、請求項12又は13に記載の方法。
- 工程(c)における精製後のヒトミルクオリゴ糖の濃度が、約1%~約5%重量/重量である、請求項1に記載の方法。
- ヒトミルクオリゴ糖の前記濃度が、約5%重量/重量である、請求項15に記載の方法。
- 請求項1~16のいずれか一項に記載の方法に従って作製された精製ヒトミルクオリゴ糖組成物。
- 5%以下のラクトースを含む、請求項17に記載の精製ヒトミルクオリゴ糖組成物。
- 図5E及び図5Fに示されるような、請求項17又は18に記載の精製ヒトミルクオリゴ糖組成物。
- NECを予防することを必要とする対象においてそれを行う方法であって、有効量の請求項17~19のいずれか一項に記載の精製HMO組成物を前記対象に投与することを含む、方法。
- 全身性炎症を減少させることを必要とする対象においてそれを行うための方法であって、有効量の請求項17~19のいずれか一項に記載の精製HMO組成物を前記対象に投与することを含む、方法。
- 感染を治療又は予防することを必要とする対象においてそれを行うための方法であって、有効量の請求項17~19のいずれか一項に記載の精製HMO組成物を前記対象に投与することを含む、方法。
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CA (1) | CA3037203A1 (ja) |
IL (2) | IL290057B2 (ja) |
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Publication number | Priority date | Publication date | Assignee | Title |
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CA3151145A1 (en) | 2019-09-24 | 2021-04-01 | David N. Cook | Compositions and methods for treatment of inflammatory and immune diseases |
WO2021064629A1 (en) * | 2019-10-01 | 2021-04-08 | Glycom A/S | Separation of neutral oligosaccharides from fermentation broth |
JP2023537608A (ja) * | 2020-08-14 | 2023-09-04 | プロラクタ バイオサイエンス,インコーポレイテッド | 細菌療法で使用するためのヒトミルクオリゴ糖組成物 |
CA3204530A1 (en) | 2021-01-12 | 2022-07-21 | Gregory Mckenzie | Synbiotic treatment regimens |
KR20230135089A (ko) | 2021-01-22 | 2023-09-22 | 프롤랙타 바이오사이언스, 인코포레이티드 | 국소 인간 모유 제형 |
EP4042875A1 (en) * | 2021-02-15 | 2022-08-17 | Rakesh Kumar Aggarwal | A human milk fortifier |
CN113899827A (zh) * | 2021-09-29 | 2022-01-07 | 中国科学院合肥物质科学研究院 | 一种3’-唾液酸乳糖的检测方法及其应用 |
WO2023122270A2 (en) * | 2021-12-23 | 2023-06-29 | Amyris, Inc. | Compositions and methods for improved production of human milk oligosaccharides |
WO2024130119A2 (en) | 2022-12-16 | 2024-06-20 | Prolacta Bioscience, Inc. | Synbiotic compositions for short chain fatty acid production |
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FR2459619B1 (fr) * | 1979-06-26 | 1983-07-29 | Agronomique Inst Nat Rech | Procede pour l'obtention a partir de lactoserum, d'un produit enrichi en alpha-lactalbumine et applications dudit procede |
US6045854A (en) * | 1997-03-31 | 2000-04-04 | Abbott Laboraties | Nutritional formulations containing oligosaccharides |
US6288222B1 (en) | 2000-02-16 | 2001-09-11 | Neose Technologies, Inc. | Method of filtration of a dairy stream |
CN101987107A (zh) * | 2003-10-24 | 2011-03-23 | 努特里奇亚有限公司 | 免疫调节性寡糖 |
PL1988786T3 (pl) * | 2006-02-10 | 2010-10-29 | Nestec Sa | Mieszanka oligosacharydowa |
US7531632B2 (en) * | 2006-02-16 | 2009-05-12 | Gtc Biotherapeutics, Inc. | Clarification of transgenic milk using depth filtration |
US8927027B2 (en) * | 2008-12-02 | 2015-01-06 | Prolacta Bioscience | Human milk permeate compositions and methods of making and using same |
EP2405918B2 (en) * | 2009-03-13 | 2020-09-02 | The Regents of The University of California | Prebiotic oligosaccharides |
TWI527522B (zh) | 2010-08-13 | 2016-04-01 | 愛之味股份有限公司 | 製備富含半乳寡醣及低乳糖之易吸收乳製品之方法及以該方法製備之機能性乳製品 |
ES2617508T3 (es) | 2011-03-14 | 2017-06-19 | Godo Shusei Co., Ltd. | Método para determinar actividad de arilsulfatasa |
EP2526784A1 (en) | 2011-05-24 | 2012-11-28 | Nestec S.A. | Milk oligosaccharide-galactooligosaccharide composition for infant formula containing the soluble oligosaccharide fraction present in milk, and having a low level of monosaccharides, and a process to produce the composition |
NL2007931C2 (en) * | 2011-12-07 | 2013-06-10 | Friesland Brands Bv | Methods for providing sialylated oligosaccharides and products obtainable thereby. |
AU2012363349B2 (en) * | 2012-01-01 | 2016-11-10 | Botanical Water Technologies Ip Ltd | Plant based beverages, and methods for preparation thereof |
EP2620506A1 (en) * | 2012-01-25 | 2013-07-31 | Arla Foods Amba | Method of producing a galacto-oligosaccharide-containing composition |
KR101379450B1 (ko) | 2013-07-23 | 2014-03-31 | 장세현 | 모유 성분인 갈락토실락토스가 강화된 갈락토올리고당의 제조 방법 |
EP3572521A1 (en) * | 2013-09-10 | 2019-11-27 | Jennewein Biotechnologie GmbH | Production of oligosaccharides |
US10368558B2 (en) | 2014-12-05 | 2019-08-06 | Godo Shusei Co., Ltd. | Lactase solution and dairy product using same |
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IL290057B1 (en) | 2023-05-01 |
RU2019110171A (ru) | 2020-10-19 |
CN109843073A (zh) | 2019-06-04 |
AU2017326654C1 (en) | 2022-07-21 |
RU2754463C2 (ru) | 2021-09-02 |
EP3515195A1 (en) | 2019-07-31 |
IL290057B2 (en) | 2023-09-01 |
CA3037203A1 (en) | 2018-03-22 |
RU2019110171A3 (ja) | 2021-02-11 |
AU2017326654B2 (en) | 2022-01-20 |
JP7143286B2 (ja) | 2022-09-28 |
BR112019005329A2 (pt) | 2019-06-18 |
KR20190054097A (ko) | 2019-05-21 |
MX2019002924A (es) | 2019-10-14 |
KR102593408B1 (ko) | 2023-10-25 |
JP2019528740A (ja) | 2019-10-17 |
IL290057A (en) | 2022-03-01 |
IL265373A (en) | 2019-05-30 |
AU2022202598B2 (en) | 2024-04-04 |
IL265373B (en) | 2022-02-01 |
AU2017326654A1 (en) | 2019-03-14 |
AU2022202598A1 (en) | 2022-05-12 |
AU2024204350A1 (en) | 2024-07-11 |
JP7510978B2 (ja) | 2024-07-04 |
US20200054035A1 (en) | 2020-02-20 |
KR20230130667A (ko) | 2023-09-12 |
WO2018053535A1 (en) | 2018-03-22 |
EP3515195A4 (en) | 2020-05-27 |
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