JP5579966B2 - 生体分子の一貫連続製造のための装置及び方法 - Google Patents

生体分子の一貫連続製造のための装置及び方法 Download PDF

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JP5579966B2
JP5579966B2 JP2007534832A JP2007534832A JP5579966B2 JP 5579966 B2 JP5579966 B2 JP 5579966B2 JP 2007534832 A JP2007534832 A JP 2007534832A JP 2007534832 A JP2007534832 A JP 2007534832A JP 5579966 B2 JP5579966 B2 JP 5579966B2
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tissue culture
flow rate
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protein
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JP2008514237A (ja
JP2008514237A5 (https=
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ボーゲル、ジェンス、ホルガー
ジョバンニーニ、ロベルト
コンスタンティノフ、コンスタンティン、ビー．
グエン、フーン、マイ
ウー、ペング
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バイヤー ヘルスケア エルエルシー
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M47/00—Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
    • C12M47/12—Purification
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins
    • C12P21/06—Preparation of peptides or proteins produced by the hydrolysis of a peptide bond, e.g. hydrolysate products
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • 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
    • 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
    • C07K1/145—Extraction; Separation; Purification by extraction or solubilisation
    • 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
    • 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
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/24—Apparatus for enzymology or microbiology tube or bottle type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/14—Pressure control
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/16—Flow or flux control
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/10—Specific supply elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/10—Specific supply elements
    • B01D2313/105—Supply manifolds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/18—Specific valves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2317/00—Membrane module arrangements within a plant or an apparatus
    • B01D2317/04—Elements in parallel

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Water Supply & Treatment (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Sustainable Development (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Filtration Of Liquid (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
JP2007534832A 2004-09-30 2005-09-30 生体分子の一貫連続製造のための装置及び方法 Expired - Lifetime JP5579966B2 (ja)

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US61499504P 2004-09-30 2004-09-30
US60/614,995 2004-09-30
PCT/US2005/035364 WO2006039588A2 (en) 2004-09-30 2005-09-30 Devices and methods for integrated continuous manufacturing of biological molecules

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JP2008514237A JP2008514237A (ja) 2008-05-08
JP2008514237A5 JP2008514237A5 (https=) 2014-07-03
JP5579966B2 true JP5579966B2 (ja) 2014-08-27

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EP (2) EP2550971B1 (https=)
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CN (2) CN102794109B (https=)
AU (1) AU2005292358B2 (https=)
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HU (2) HUE027136T2 (https=)
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Families Citing this family (79)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006039588A2 (en) 2004-09-30 2006-04-13 Bayer Healthcare Llc Devices and methods for integrated continuous manufacturing of biological molecules
TWI456062B (zh) 2006-09-13 2014-10-11 Abbvie Inc 細胞培養改良
US8911964B2 (en) 2006-09-13 2014-12-16 Abbvie Inc. Fed-batch method of making human anti-TNF-alpha antibody
FR2920429B1 (fr) * 2007-08-30 2012-10-05 Lfb Biotechnologies Procede de purification du facteur viii et du facteur von willebrand
MX2011004201A (es) 2008-10-20 2011-05-24 Abbott Lab Desactivacion viral durante purificacion de anticuerpos.
AU2009347206C1 (en) 2008-10-20 2016-12-08 Abbvie Inc. Isolation and purification of antibodies using Protein A affinity chromatography
US9527010B2 (en) 2009-09-25 2016-12-27 Ge Healthcare Bio-Sciences Corp. Separation system and method
EP2627428A4 (en) * 2010-10-15 2016-08-31 Ge Healthcare Bio Sciences ONE-WAY ULTRA-FILTRATION SYSTEMS AND METHODS OF LARGE VOLUME
CN102154408B (zh) * 2011-01-13 2013-06-05 天津市工业微生物研究所 小核菌硬葡聚糖在线发酵提取方法及系统
US9982227B2 (en) 2011-03-08 2018-05-29 University Of Maryland, Baltimore County System and method for production of on-demand proteins in a portable unit for point of care delivery
US12227734B2 (en) 2011-03-08 2025-02-18 University Of Maryland, Baltimore County Microscale bioprocessing system and method for protein manufacturing from human blood
US10774304B2 (en) * 2011-03-08 2020-09-15 University Of Maryland, Baltimore County System and method for production of on-demand proteins in a portable unit for point of care delivery
US9388373B2 (en) * 2011-03-08 2016-07-12 University Of Maryland Baltimore County Microscale bioprocessing system and method for protein manufacturing
EP2702077A2 (en) 2011-04-27 2014-03-05 AbbVie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
MX354237B (es) * 2011-10-11 2018-02-19 Sentry Depressurization Systems Inc Sistema de despresurizacion para un transformador electrico.
WO2013109520A1 (en) 2012-01-18 2013-07-25 Bayer Healthcare Llc Perfusion bioreactor systems and methods of operating the same
US9997264B2 (en) * 2012-02-14 2018-06-12 Control Components, Inc. Enhanced nuclear sump strainer system
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
US9150645B2 (en) 2012-04-20 2015-10-06 Abbvie, Inc. Cell culture methods to reduce acidic species
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
US9249182B2 (en) 2012-05-24 2016-02-02 Abbvie, Inc. Purification of antibodies using hydrophobic interaction chromatography
EP2682168A1 (en) 2012-07-02 2014-01-08 Millipore Corporation Purification of biological molecules
HK1211981A1 (en) 2012-09-02 2016-06-03 Abbvie Inc. Methods to control protein heterogeneity
US9512214B2 (en) 2012-09-02 2016-12-06 Abbvie, Inc. Methods to control protein heterogeneity
EP2958988A2 (en) 2013-02-22 2015-12-30 Genzyme Corporation Microcarrier perfusion culturing methods and uses thereof
CN105143443A (zh) 2013-02-22 2015-12-09 建新公司 微载体灌注培养方法及其用途
SG10201709131UA (en) 2013-03-08 2017-12-28 Genzyme Corp Continuous purification of therapeutic proteins
SG11201507230PA (en) 2013-03-12 2015-10-29 Abbvie Inc Human antibodies that bind human tnf-alpha and methods of preparing the same
US9017687B1 (en) 2013-10-18 2015-04-28 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same using displacement chromatography
US8921526B2 (en) 2013-03-14 2014-12-30 Abbvie, Inc. Mutated anti-TNFα antibodies and methods of their use
WO2014151878A2 (en) 2013-03-14 2014-09-25 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosacharides
US9598667B2 (en) 2013-10-04 2017-03-21 Abbvie Inc. Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins
US9085618B2 (en) 2013-10-18 2015-07-21 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same
US8946395B1 (en) 2013-10-18 2015-02-03 Abbvie Inc. Purification of proteins using hydrophobic interaction chromatography
US9181337B2 (en) 2013-10-18 2015-11-10 Abbvie, Inc. Modulated lysine variant species compositions and methods for producing and using the same
US20150139988A1 (en) 2013-11-15 2015-05-21 Abbvie, Inc. Glycoengineered binding protein compositions
TWI709569B (zh) 2014-01-17 2020-11-11 美商健臻公司 無菌層析樹脂及其用於製造方法的用途
TWI671312B (zh) 2014-01-17 2019-09-11 美商健臻公司 無菌層析法及製法
US20170058308A1 (en) * 2014-05-02 2017-03-02 Novo Nordisk A/S Integrated continuous biomanufacturing process
CA3140009C (en) 2014-05-13 2023-09-05 Amgen Inc. Process control systems and methods for use with filters and filtration processes
WO2015183716A1 (en) * 2014-05-27 2015-12-03 Artificial Cell Technologies, Inc. Automated layer by layer construction of multilayer coated cores by tff
TW202204596A (zh) 2014-06-06 2022-02-01 美商健臻公司 灌注培養方法及其用途
TWI776235B (zh) 2014-06-09 2022-09-01 美商健臻公司 種子罐培養法(seed train processes)及其用途
US10207225B2 (en) 2014-06-16 2019-02-19 Emd Millipore Corporation Single-pass filtration systems and processes
US10550148B2 (en) 2014-06-16 2020-02-04 Emd Millipore Corporation Methods for increasing the capacity of flow-through processes
JP6339674B2 (ja) 2014-06-25 2018-06-06 イー・エム・デイー・ミリポア・コーポレイシヨン 小型スパイラル型フィルターエレメント、モジュール、およびシステム
KR102079585B1 (ko) 2014-08-29 2020-02-21 이엠디 밀리포어 코포레이션 잔류물의 재순환을 이용한 싱글 패스 접선 유동 여과 시스템 및 접선 유동 여과 시스템
US10350518B2 (en) 2014-08-29 2019-07-16 Emd Millipore Corporation Processes for filtering liquids using single pass tangential flow filtration systems and tangential flow filtration systems with recirculation of retentate
USD761381S1 (en) 2014-12-18 2016-07-12 Emd Millipore Corporation Retentate plate
USD762811S1 (en) 2014-12-18 2016-08-02 Emd Millipore Corporation Diverter plate
EP3093335A1 (de) 2015-05-13 2016-11-16 Bayer Technology Services GmbH Prozessleitsystem zur regelung und steuerung einer modular aufgebauten anlage zur produktion von biopharmazeutischen und biologischen makromolekularen produkten
ITUA20161506A1 (it) * 2016-03-09 2017-09-09 Della Toffola Spa Metodo ed impianto perfezionato di filtrazione tangenziale
WO2017160739A1 (en) 2016-03-14 2017-09-21 Pendo TECH Processing system for multiple tangential flow filtration stations in bioprocessing applications
ES2925059T3 (es) 2016-06-09 2022-10-13 Emd Millipore Corp Elementos de filtro de trayectoria radial, sistemas y métodos de uso de los mismos
SG10202108510UA (en) * 2016-07-21 2021-09-29 Agency Science Tech & Res Apparatus for outer wall focusing for high volume fraction particle microfiltration and method for manufacture thereof
CA3043294A1 (en) * 2016-11-11 2018-05-17 Bayer Aktiengesellschaft Method for sampling fluid streams for monitoring contaminants in a continuous flow
EP3141594A3 (en) * 2016-11-11 2017-06-14 Bayer Pharma Aktiengesellschaft Method for sampling fluid streams for monitoring contaminants in a continuous flow
WO2018107099A1 (en) * 2016-12-09 2018-06-14 Lonza Ltd Method for the reduction of viral titer in pharmaceuticals
EP3354330A1 (en) * 2017-01-25 2018-08-01 Sartorius Stedim Biotech GmbH Automated modular filtration system
CA2994643A1 (en) * 2017-02-14 2018-08-14 Bart Lipkens Bioreactor using acoustic standing waves
CN110268043A (zh) * 2017-03-03 2019-09-20 富士胶片株式会社 细胞培养装置及细胞培养方法
JP2018153168A (ja) * 2017-03-21 2018-10-04 国立大学法人九州大学 微生物収集装置
DE102017110482A1 (de) * 2017-05-15 2018-11-15 Sartorius Stedim Biotech Gmbh Filtrationsmodul bzw. Reinigungsmodul für modulares Filtrationssystem
DE102017111133A1 (de) 2017-05-22 2018-11-22 Sartorius Stedim Biotech Gmbh Vorkonfigurierte Einweg-Filtrationsvorrichtung
TWI675696B (zh) * 2017-06-01 2019-11-01 美商Ｅｍｄ密理博公司 用於灌注應用之切向流過濾裝置
US11364469B2 (en) 2017-06-20 2022-06-21 Asahi Kasei Kabushiki Kaisha Hollow fiber membrane module and filtering method
TWI846694B (zh) * 2018-05-04 2024-07-01 美商健臻公司 具有過濾系統的灌注式生物反應器
US12071607B2 (en) * 2018-06-01 2024-08-27 Lonza Ltd. Midscale model for organic growth and phasing
GB201810772D0 (en) * 2018-06-29 2018-08-15 Ge Healthcare Bio Sciences Ab Method in bioprocess purification system
HK40046210A (en) 2018-08-31 2021-10-29 Genzyme Corporation Sterile chromatography resin and use thereof in manufacturing processes
GB201816871D0 (en) 2018-10-17 2018-11-28 Ge Healthcare Bio Sciences Ab A bioprocessing fluid sensor arrangement
DE102019100209A1 (de) 2019-01-07 2020-07-09 Sartorius Stedim Biotech Gmbh Vorrichtung und Verfahren zum Ausgleich von kurzfristigen Druck- oder Volumenschwankungen eines Mediums in einem kontinuierlich geführten biopharmazeutischen Prozess
JP2022520793A (ja) * 2019-02-15 2022-04-01 ジャスト－エヴォテック バイオロジックス、インコーポレイテッド 自動バイオ製造システム、施設、及びプロセス
CN111018968B (zh) * 2019-12-16 2021-07-27 兴盟生物医药(苏州)有限公司 一种通过超滤浓缩制备高浓度抗体制剂的方法
US12050448B2 (en) 2021-01-29 2024-07-30 Tata Consultancy Services Limited Method and system to control a continuous bioprocessing
GB202109015D0 (en) * 2021-06-23 2021-08-04 Puridify Ltd A method for purifying a feed in a chromatography system
CN118984710A (zh) * 2022-03-30 2024-11-19 富士胶片株式会社 生物制药的原料药的制造方法、生物制药的原料药的制造系统及生物制药的原料药
WO2023191009A1 (ja) * 2022-03-30 2023-10-05 富士フイルム株式会社 バイオ医薬品の原薬の製造方法、バイオ医薬品の原薬の製造システム、およびバイオ医薬品の原薬
US12157873B2 (en) * 2022-09-28 2024-12-03 Genzyme Corporation Systems and devices for producing biological products and methods of using the same

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5157113A (en) * 1987-08-10 1992-10-20 Miles Inc. Removal of nucleic acids from monoclonal antibody preparations
US5256294A (en) * 1990-09-17 1993-10-26 Genentech, Inc. Tangential flow filtration process and apparatus
US5463029A (en) * 1992-11-23 1995-10-31 Immunex Corporation Purification of fusion proteins comprising GM-CSF and IL-3
JP3863559B2 (ja) * 1994-05-16 2006-12-27 メルク エンド カンパニー インコーポレーテッド 乳頭腫ウィルスワクチン
US5616595A (en) * 1995-06-07 1997-04-01 Abbott Laboratories Process for recovering water insoluble compounds from a fermentation broth
JP3566461B2 (ja) 1996-06-28 2004-09-15 ユニ・チャーム株式会社 使い捨ての体液吸収性物品
US7122344B2 (en) * 1997-05-28 2006-10-17 Claragen, Inc. Methods for the production of purified recombinant human uteroglobin for the treatment of inflammatory and fibrotic conditions
IT1302026B1 (it) * 1997-08-22 2000-07-20 Hoffmann La Roche Materiali immunologici e metodi per la rivelazione di diidropirimidinadeidrogenasi.
US6022477A (en) * 1997-11-14 2000-02-08 New Jersey Institute Of Technology Method and apparatus for isolation purification of biomolecules
US7820796B2 (en) 1998-03-12 2010-10-26 Genetics Institute, Llc. Methods for producing Factor VIII proteins
US6444223B1 (en) * 1999-05-28 2002-09-03 Alkermes Controlled Therapeutics, Inc. Method of producing submicron particles of a labile agent and use thereof
US6544424B1 (en) * 1999-12-03 2003-04-08 Refined Technology Company Fluid filtration system
US6350382B1 (en) * 2000-06-23 2002-02-26 Scilog, Inc. Enhancing filtration yields in tangential flow filtration
EP1417475A4 (en) * 2001-07-06 2006-06-28 454 Corp METHOD FOR ISOLATING INDEPENDENT, PARALLEL CHEMICAL MICRORE ACTIONS USING A POROUS FILTER
KR100909316B1 (ko) * 2001-08-31 2009-07-24 바이엘 헬스케어 아게 고세포밀도 발효를 수행하기 위한 유닛 및 방법
US6875459B2 (en) * 2001-09-10 2005-04-05 Henry B. Kopf Method and apparatus for separation of milk, colostrum, and whey
WO2003062374A2 (en) * 2001-11-09 2003-07-31 Entremed, Inc. Synthetic genes for malarial proteins and methods of use
CA2457262A1 (fr) * 2003-02-11 2004-08-11 Centre National En Electrochimie Et En Technologies Environnementales In C. Procede et dispositif pour la production de biomolecules en continu
CA2516836A1 (en) * 2003-02-24 2004-09-10 Gtc Biotherapeutics, Inc. Methods of tangential flow filtration and an apparatus therefore
US20050197496A1 (en) 2004-03-04 2005-09-08 Gtc Biotherapeutics, Inc. Methods of protein fractionation using high performance tangential flow filtration
WO2006039588A2 (en) 2004-09-30 2006-04-13 Bayer Healthcare Llc Devices and methods for integrated continuous manufacturing of biological molecules

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