Multi-column Continuous Capture Chromatography New data confirming significant savings and de-bottlenecking opportunities
|
|
- Kathryn Allison
- 6 years ago
- Views:
Transcription
1 Multi-column Continuous Capture Chromatography New data confirming significant savings and de-bottlenecking opportunities Dr.-Ing. Kathleen Mihlbachler, LEWA Bioprocess Repligen Seminar: Advances in Bioprocessing, Princeton, NJ, 20 June 2017
2 Agenda Who we are, what we do Drivers to multi-column capture chromatography Streamline twin-column system Verification at process scale during customer trials LEWA-Nikkiso America Inc. 2
3 LEWA Bioprocess Group is part of the global family of companies under the $1.3B US Nikkiso Corporation (1953) Business sites in >80 countries, >6,000 employees LEWA Bioprocess Group Engineering Fabrication LEWA-Nikkiso America, Inc. Sales Engineering Fabrication LEWA GmbH Headquarters Industrial Division Sales Engineering Pump production Fabrication Nikkiso Co., Ltd. Group Headquarters
4 Who we are, what we do LEWA Bioprocess Technologies Group A group of ~ 60+ professionals dedicated to GMP scale bioprocess systems design and manufacture. Part of the ~ 6,000 employees of Nikkiso Corp. a diversified company with $1.3B in revenue. Location Date of Establishment Ownership About LEWA GMP systems engineering, manufacturing & automation; Chromatography Buffer In-line Dilution TFF Downstream process skids Markets: Biopharmaceutical Pharmaceutical OEM (bio/pharma) Devens, MA USA 2000 Acquired in 2014, we are now a group within LEWA-Nikkiso America, Inc. The LEWA group ($280M US) is a manufacturer of metering pump headquartered in Leonberg, DE. LEWA was acquired by Nikkiso in Both Nikkiso & LEWA founded ~65 years ago Video Link Here 4 7/10/2017 7/10/ LEWA Process Technologies, Inc.
5 Agenda Who we are, what we do Drivers to multi-column capture chromatography Streamline twin-column system Verification at process scale during customer trials LEWA-Nikkiso America Inc. 5
6 A paradigm shift to continuous bio-production Drivers Third party payer cost pressure driving need for higher productivity Improved ratio up/down time Biosimilar/biobetter demand to be more cost effective Space constraints: closed processing without hold-up tanks at smaller scale Flexibility when scaling-up to scale out FDA encouraging implementation of continuous processes: Increase quality, reduced production risks Make drugs more available to more populations 6
7 Why continuous chromatography for capture? Harvest Feed Bleed Eluent Upstream Perfusion Culture Continuous capture Drivers to transfer capture to continuous operation: Breaking the bottleneck in DSP due to higher titers and continuous upstream Volume reduction of harvest - Space constraints Scale down of conventional LPLC systems Elimination of large buffer and hold-up tanks Scale down of columns (required for traditional capture up to 250 L) Under utilization of Protein A binding capacity (30-50%) 7
8 Transition from batch to continuous capture Single column batch chromatography Load 30-50% unused resin capacity Two-column continuous batch chromatography Interconnected operation Load Parallel operation Recovery Product elution Load Higher resin utilization > 90% OpEx reduction Higher feed and process flow rates higher throughput Reduced buffer consumption OpEx reduction 8
9 Agenda Who we are, what we do Drivers to multi-column capture chromatography Streamline twin-column system Verification at process scale during customer trials LEWA-Nikkiso America Inc. 9
10 Simplicity 8 column process CUBE from ChromaCon LEWA EcoPrime Twin ~240 Valves ~40 Valves The 2-column approach reduces risk Accelerates validation Simplifies maintenance Lessens costly downtime Minimizes hold-up & operating expenses Streamlines implementation; easy-tounderstand and use Similar productivity as systems with 3 or more columns, in a simple 2-column design. and 10
11 Process automation example HMI Main screen (EcoPrime Twin System) Process flow chart with sensors to monitor and control process. Trends, Sequences and Recipes, Reporting and Alarms User trained on day 1 and up and running on day 2 Connected I2: Column 2 in first position 11
12 Continuous Capture using the 2-column system CaptureSMB Process Patent by ChromaCon 12
13 Recipe driven process configuration (EcoPrime Twin 100) Access control Second person Verification, different recipe stages: Development, Production and Archived 13
14 Agenda Who we are, what we do Drivers to multi-column capture chromatography Streamline twin-column system Verification at process scale during customer trials Skid performance Customer A 1 g/l mab Customer B 5 g/l mab LEWA-Nikkiso America Inc. 14
15 Extended run time performance verification Long-term study over 210 loads (13 days) (EcoPrime Twin 100) Feed pump (ml/min) Monitoring feed flow rate and pump discharge pressure (Shown - last 24 hours only) discharge (bar) Consistent and robust performance 15
16 Reproducibility performance verification (EcoPrime Twin 100) Shown: monitoring conductivity at the outlet of both columns Consistent & reproducible performance 16
17 Simple transfer from batch to continuous capture Customer A - process development run comparison with 1g/L titer mab Batch Capture Total CV 7.85 L Continuous Capture Total CV 1.6 L CV Linear [cm/h] Column Equilibration Load Wash Wash Wash Elution post wash post wash 2* Regen* Process time: 9 h CV Load Start-Up 15 Load Connected 27 Load Parallel 22 Wash 1 connected 1 Wash 1 Parallel 1 Wash 2 2 Wash 3 3 Elution 3 Post-Wash1 2 Post Wash 2 1 Regeneration 3 Re-Equilibration 5 Cycle time: 4 h at linear velocity of 250 cm/h Essentially same process steps simple process transfer Higher load volume 40 vs 49 CVs higher resin utilization & reduce buffer consumption Shorter residence times faster loading & shorter processing time 17
18 Continuous capture reproducibility Customer A 1g/L titer run results at 40 g/l load 7 peaks overlaid Column 1 At steady state, variability in peak area < 0.25 %. Steady state can be reached with first elution. Column 2 Peak Area column1 column Average error % EcoPrime Twin 18
19 Optimized continuous capture reproducibility Customer A 1g/L titer mab: 50 g/l load 5 peaks overlaid EcoPrime Twin Column 1 Peak Area Column 1 Column Average error %* At steady state, variability of peak area is <1 %. Steady state can be reached with first elution. Column 2 19
20 Comparison batch to continuous capture Customer A - process development run: 1g/L titer mab Triple productivity or 67 % less resin and ~ 30% buffer reduction 20
21 Scale-up estimate Customer A 1 g/l titer estimate for 100-kg process scale-up Savings up to $900K in resin or 22 days in processing time. And 15,000 L of buffer. 21
22 Seamless transfer from batch to continuous capture Customer B pilot plant process comparison; 5 g/l titer mab Batch capture Load 50 g/l resin Total CV 17.3 L Continuous capture Load 80 g/l resin Total CV 1.6 L CV linear [cm/h] Pre Sanitization Equilibration Load Wash Wash Wash Elution CIP Neutralization Sanitization Neutralization Storage Process time: 4.5 h CV linear [cm/h] Pre Sanitization Equilibration Load Load interconnected Wash Wash Wash Elution CIP Re-equilibration Sanitization Neutralization Storage Cycle time: 2.5 h Same process steps simple process transfer Higher load 10 vs 16 CVs higher resin utilization & reduce buffer consumption Faster linear velocity shorter processing time 22
23 Reproducibility and scalability Customer B 5g/L titer mab: 80 g/l load EcoPrime Twin run with 14-h process time peak # Column 1 Column 2 peak area peak area average error %* Similar chromatograms when scaling up and down Contichrom Cube run with 12-h process time Steady state can be reached with first elution. Variability of peak area is ~1 % at steady state 23
24 Comparison batch to continuous capture Customer B - process development run: 5 g/l titer mab Productivity - Customer B Buffer Consumption - Customer B Productivity [g/lresin/h] Buffer Consumption [L/g] Batch EcoPrime Twin Contichrom Cube 0 Batch EcoPrime Twin Contichrom Cube > 2X productivity or 50 % less resin and ~ 50 % buffer reduction 24
25 Scale-up estimate Customer B 5 g/l titer estimate for 100-kg process scale-up Savings up to $320K in resin or 6.1 days in processing times. Plus 37,000L of buffer. 25
26 Customer experience on mab shows Twin column capture delivers: Significant productivity gains 2-3 times Substantial cost or time savings Better Protein A utilization Faster loading Shorter processing time Reduced buffer consumption % Seamless scale up Same process steps Proven reproducibility Simple 2-column approach and system Accelerate implementation Minimize risk LEWA Nikkiso America Inc. 28
27 For more information: America s Europe Asia LEWA-Nikkiso America, Inc. 132 Hopping Brook Road MA Holliston Tel: Fax: sales@lewa-inc.com Headquarters LEWA GmbH Ulmer Str Leonberg GERMANY Tel: Fax: lewa@lewa.de NIKKISO CO. LTD. Yebisu Garden Place Tower 22nd Floor 20-3, Ebisu 4-Chome, Shibuya-ku Tokyo Tel: Fax: LEWA, Creating Fluid Solutions, the LEWA logo, LEWA Intellidrive and LEWA EcoPrime are trademarks of LEWA GmbH. ChromaCon, Contichrom and CaptureSMB are registered marks of ChromaCon AG. All goods and services are sold subject to the terms and conditions of sale of the company within LEWA which supplies them. A copy of these terms and conditions is available on request. Contact your local LEWA representative for the most current information LEWA Nikkiso America, Inc. All rights reserved. LEWA Bioprocess Technologies, Inc. 8 Charlestown Road Devens, MA USA Tel: sales@lewapt.com
28 ChromaCon / LEWA Partnership LEWA is global GMP scale up partner for ChromaCon twin column technology. Control logic for operating two columns on a single system. ChromaCon Process know-how Intellectual property Entry-stage equipment CaptureSMB LEWA Scale-up Equipment Process solutions Continuous manufacturing Worldwide Footprint MCSGP Technical, marketing and sales collaboration. Work protected by various patents 30
29 Huge productivity System/Model Column ID Range (cm) Feed per day (L/day) Product recovered* (kg/day) EP Twin L/min EP Twin L/min EP Twin L/min , , *Process dependent 10 cm ID columns More than 300 L feed processed/day More than 1 kg mab purified/day LEWA Bioprocess Group and 31
30 Twin column LPLC skid layout EcoPrime Twin Flow meters Outlet valve block Column inlet valve block Column outlet valve block 1. Symmetric design 2. Minimum hold-up volume 3. Simple piping design ph probe 2 UV detectors 2 conductivity and temperature 2 ecodos pumps Pump A (Buffer) with 6 inlets Pump B (feed) with 4 inlets Single outlet valve Column inlets and outlets and their by-passes 32
Multi-Column Continuous Chromatography
Multi-Column Continuous Chromatography LEWA Bioprocess Technologies Group, Devens, MA USA Increasing productivity and decreasing cost in the downstream process Built on patented & licensed technology from
More informationLEWA EcoPrime Twin LPLC
LEWA EcoPrime LPLC Multi-functional, twin column continuous chromatography in a simple, robust design. Leading the continuous processing evolution The LEWA EcoPrime LPLC is an easy-to-use, GMP-ready, multi-column
More informationEcoPrime SMB. Simulated Moving Bed Chromatography By LEWA-Nikkiso featuring Bayer * technology. Technology enabling chiral separations - efficiently
EcoPrime SMB Simulated Moving Bed Chromatography By LEWA-Nikkiso featuring Bayer * technology Technology enabling chiral separations - efficiently *patented technology licensed from Bayer AG Separating
More informationBuffer In-line Dilution: Superior Performance with Volume Based Control. Mary Jo Wojtusik, Ph.D.
Buffer In-line Dilution: Superior Performance with Volume Based Control Mary Jo Wojtusik, Ph.D. / 2017 Agenda Buffer in-line dilution (BID) Approaches to BID BID with volumetric flow control LPLC with
More informationLEWA EcoPrime LPLC. With integrated buffer in-line dilution.
LEW EcoPrime LPLC With integrated buffer in-line dilution. LEW EcoPrime LPLC Complete solution LEW EcoPrime LPLC Complete solution 01 LEW EcoPrime LPLC. With integrated buffer in-line dilution option.
More informationPeriodic countercurrent (PCC)
B i o P r o c e s s TECHNICAL Scale-Up of Twin-Column Periodic Counter-Current Chromatography for MAb Purification James Angelo, John Pagano, Thomas Müller-Späth, Kathleen Mihlbachler, Srinivas Chollangi,
More informationImplementing Continuous Chromatography into DSP of Bio-Molecules
into DSP of Bio-Molecules 2014 Prep Symposium in Boston, MA Kathleen Mihlbachler Global Director of Separations Development LEWA Process Technologies kmihlbachler@lewapt.com Objective Improve the economical,
More informationHigh Purity Systems. Technical and Commercial Certainty. listen create manufacture service
High Purity Systems Technical and Commercial Certainty listen create manufacture service From concept to product: we take care Listen, Create, Manufacture and Service LEWA are process experts and can help
More informationThe Contichrom CUBE FPLC System. A Twin-Column Protein Purification System for Batch and Continuous Processing
The Contichrom CUBE FPLC System A Twin-Column Protein Purification System for Batch and Continuous Processing The Contichrom CUBE Platform Buy what you need Twin-Column Preparative FPLC System The Contichrom
More informationThe Future is NOW for Continuous Manufacturing Part 3 Multi Column Continuous (MCC) Chromatography
The Future is NOW for Continuous Manufacturing Part 3 Multi Column Continuous (MCC) Chromatography Dr. Kathleen Mihlbachler Global Director of Separation Development LEWA Process Technologies 15 01 2015
More informationAutomated in-line buffer preparation from readymade stock solutions in a mab process step
GE Healthcare Automated in-line buffer preparation from readymade stock solutions in a mab process step Buffer preparation is both time-and space-consuming and can easily become a challenge in biomanufacturing.
More informationPerfusion and Beyond The XCell TM ATF System
Perfusion and Beyond The XCell TM ATF System Earl Pineda Field Application Scientist Web ads May 9, 2018 Inspiring advances in bioprocessing since 1985 Repligen Corporation: one of the fastest-growing
More informationThe Contichrom CUBE FPLC Systems. Twin-Column Protein Purification Systems for Batch and Continuous Processing
The Contichrom CUBE FPLC Systems Twin-Column Protein Purification Systems for Batch and Continuous Processing The Contichrom CUBE Platform Twin-Column Preparative FPLC System The Contichrom CUBE and CUBE
More informationThe Contichrom CUBE FPLC Systems. Twin-Column Protein Purification Systems for Batch and Continuous Processing
The Contichrom CUBE FPLC Systems Twin-Column Protein Purification Systems for Batch and Continuous Processing The Contichrom CUBE Platform Twin-Column Preparative FPLC System The Contichrom CUBE and CUBE
More informationBioprocess Chrom Systems
Bioprocess Chrom Systems Combining gradient and inline buffer dilution capability with powerful software to your specifications BPC BIC Equipment designed to respect your individual needs. 2 Built For
More informationÄKTA pcc 75. General system description. GE Healthcare. Chromatography systems
GE Healthcare Chromatography systems ÄKTA pcc 75 ÄKTA pcc 75 chromatography system is developed for purification of target proteins in continuous downstream processes using periodic countercurrent chromatography
More informationPredictable scale-up through column design and robust packing methodology
GE Healthcare Predictable scale-up through column design and robust packing methodology Johan Karlsson, Johan Tschöp, and Joakim Svensson. Posters presented at IBC BioProcess International Conference and
More informationThe monoclonal antibody (MAb) market
Reimagining Capacity for Today s Purification of Monoclonal Antibodies Jonathan Royce The monoclonal antibody (MAb) market has grown over the past decade to be about half of the biomanufacturing market
More informationInline Conditioning system
GE Healthcare Frequently asked questions Inline Conditioning system Buffer preparation can be both time-and spaceconsuming and can easily become a challenge in biomanufacturing. In-line preparation of
More informationBuffer Make up Comparison: Continuous Inline versus Cycling Batch. Greg Lepak Craig Sandstrom
Buffer Make up Comparison: Continuous Inline versus Cycling Batch Greg Lepak Craig Sandstrom Agenda Sample Projects Model Process & Key Assumptions Buffer Estimates Equipment Flow Diagram Comparisons Process
More informationNew technologies in biopharmaceutical processes BioTech Vaccines Plasma
New technologies in biopharmaceutical processes BioTech Vaccines Plasma Dominik Arnold dominik_arnold@pall.com Challenges in Down Stream Processing Higher. Titers >4 g/l Yield > 90% Protein concentration
More informationEnd-to-End Integrated Continuous Manufacture of Monoclonal Antibodies
End-to-End Integrated Continuous Manufacture of Monoclonal Antibodies Fabian Steinebach, Daniel Karst, Massimo Morbidelli, ETH Zurich 11/17/216 1 Continuous Integrated Production Opinion: Higher demands
More informationMabSelect PrismA. gelifesciences.com/bioprocess
is a next-generation Protein A chromatography resin that offers significantly enhanced alkaline stability and binding capacity for improved process economy in monoclonal antibody (mab) processing. The
More informationColumn Packing of Cellufine Sulfate
Column Packing of Cellufine Sulfate Cellufine Sulfate is an affinity chromatography resin designed for the concentration, purification and depyrogenation of virus, viral coat, virus like particles (VLP)
More informationDriving Value through Innovation in Biotech Manufacturing. Agenda
Driving Value through Innovation in Biotech Manufacturing Jorg Thommes, PhD Senior Vice President Operations Technology and Innovation Biogen 7 October 2015 Agenda Biopharma Legacy, Trends, & Challenges
More informationThe Contichrom HPLC System
The Contichrom HPLC System A Preparative Twin-Column Purification System for Batch and Countercurrent Processes The Contichrom HPLC Platform The Contichrom HPLC is a preparative chromatography system.
More informationBioprocessing Challenges: High-Titer Mammalian-Based Cell Systems. Elements influencing the way Biologics may be manufactured /supplied in the future
Bioprocessing Challenges: High-Titer Mammalian-Based Cell Systems Jonathan Romero CMC Leadership, Technical Development Pharmaceutical Operations & Technology 2015 ISPE PRODUCT SHOW Business Drivers Elements
More informationManufacturing Solutions to enhance filtration and chromatography productivity
Manufacturing Solutions to enhance filtration and chromatography productivity Biopharmaceutical process development and manufacturing are facing significant increases in R&D costs together with longer
More informationContinuously Improving Bioprocesses: Biopharmaceutical Capabilities
Continuously Improving Bioprocesses: Biopharmaceutical Capabilities Pall Corporation A Legacy of Innovation Dr. David B. Pall Founded by Dr. David B. Pall in 1946, Pall Corporation has grown from a company
More informationPhenyl Sepharose High Performance Butyl Sepharose High Performance
Instructions 71-7129-00 AF Hydrophobic interaction Phenyl Sepharose High Performance Butyl Sepharose High Performance Phenyl Sepharose TM High Performance and Butyl Sepharose High Performance are members
More informationRecipients of the Nobel Prize in physics support the development of the first deep-ultraviolet LEDs
Press release (+ images, starting on p. 5) Page 1 of 6 UV LEDs replace conventional UV light sources, making innovative applications possible Recipients of the Nobel Prize in physics support the development
More informationContichrom overview. all-in-one purification equipment with a novel process principle. UCB Slough November 12 th 2012
Contichrom overview all-in-one purification equipment with a novel process principle UCB Slough November 12 th 2012 // www.chromacon.ch // Contichrom overview // for Knauer // February 13th 2013 1 Contichrom
More informationCapacity and performance of MabSelect PrismA protein A chromatography resin
Capacity and performance of protein A chromatography resin is a protein A resin of which both the ligand and the base matrix have been optimized. The resin exhibits improved capacity over its predecessor
More informationPlanova Virus Filtration Systems. Automated virus removal for clinical- to commercial-scale manufacturing
Planova Virus Filtration Systems Automated virus removal for clinical- to commercial-scale manufacturing Built For You. Asahi Kasei Bioprocess is dedicated to unlocking efficiencies and driving productivity
More informationRE-SHOWING: Continuous Manufacturing of Biopharmaceuticals
ISPE Boston Area Chapter Presents: RE-SHOWING: Continuous Manufacturing of Biopharmaceuticals Thursday, March 30, 2017 5:30 pm to 8:30 pm RE-SHOWING OF MARCH 16 th PROGRAM AT THANK YOU TO OUR PROGRAM SPONSOR
More informationFuture biologics manufacturing
Future biologics manufacturing Process integration with single-use technology Dr. Günter Jagschies Senior Director, Strategic Customer Relations GE Healthcare Life Sciences Uppsala, Sweden Mammalian Cell
More informationContinuous Purity Technological, Regulatory and Validation Considerations for single-use continuous downstream processing
Marc Bisschops Tarpon Biosystems Inc. Continuous Purity Technological, Regulatory and Validation Considerations for single-use continuous downstream processing Integrated Continuous Biomanufacturing Castelldefels
More informationFast Trak Services: Ongoing collaboration aims to accelerate biosimilar approval in China
GE Healthcare Fast Trak Services: Ongoing collaboration aims to accelerate biosimilar approval in China A case study Fast Trak Services Ongoing collaboration aims to accelerate biosimilar approval in China
More informationFast Trak Services: Long-term collaboration supports speed to market in single-use biomanufacturing
GE Healthcare Fast Trak Services: Long-term collaboration supports speed to market in single-use biomanufacturing A case study Fast Trak Services Long-term collaboration supports speed to market in single-use
More informationDownstream processing is a
V E N D O RVoice Multicolumn Chromatography A New Approach to Relieving Capacity Bottlenecks for Downstream Processing Efficiency Margit Holzer, Hector Osuna-Sanchez, and Laurent David Downstream processing
More informationHow do you maximize purity and yield? 2 Continuous counter-current chromatography
How do you maximize purity and yield? 2 Continuous counter-current chromatography Get purity and yield! The SMB Principle In SMB processes you do not have to decide for either yield or purity go for both!
More informationand 40-III Biochromatography Systems
 K-Prime 40-I, 40-II, and 40-III Biochromatography Systems DATA SHEET Broad flow rate range expands processing capabilities New Batch Reporting features conform to regulatory requirements Recipe Editor
More informationColumn Packing of Cellufine A-500 ion exchange chromatography resin
Column Packing A-500 Column Packing of Cellufine A-500 ion exchange chromatography resin the column inlet. For large columns with a slurry Cellufine A-500 is a conventional weak anion exchange resin which
More informationSEEING THE FUTURE A REVIEW OF THE ISPE 2016 FACILITY OF THE FUTURE CONFERENCE. Phil McDuff VP Global Engineering Biogen
SEEING THE FUTURE A REVIEW OF THE ISPE 2016 FACILITY OF THE FUTURE CONFERENCE Phil McDuff VP Global Engineering Biogen Robert Chew President & CEO Commissioning Agents Inc. Jim McGlade Client Leader BHDP
More informationHigh Purity Systems. Technical and Commercial Certainty. listen create manufacture service
High Purity Systems Technical and Commercial Certainty listen create manufacture service From concept to product: We take care Listen, Create, Manufacture and Service LEWA process experts can help solve
More informationThe Contichrom Process Portfolio and Software Tools
The Contichrom Process Portfolio and Software Tools Superior twin column chromatography processes for chromatographic purification operated by Contichrom systems The Contichrom Process Portfolio The Contichrom
More informationContinuous mab Purification Process: Design Features and Practical Considerations
Continuous mab Purification Process: Design Features and Practical Considerations Joanna Pezzini CASSS DC Area Discussion Group Meeting December 7, 2017 Outline Continuous Process Overview Continuous Technologies
More informationHow can flexibility and process economics be combined in one LC system?
How can flexibility and process economics be combined in one LC system? Laguna Design Contichrom lab equipment for superior LC purification Which aspects are important for a purification system? Introducing
More informationKeeping ahead in biopharmaceutical manufacturing
Keeping ahead in biopharmaceutical manufacturing Bioprocessing Network Annual Conference 2009 1 st October 2009 Dr Owen Tatford Process Development Manager May 2009 Biostate Process Overview 1 Introduction
More informationSingle-use technology in downstream unit operations
Single-use technology in downstream unit operations ÄKTA ready chromatography system and more Madhu Raghunathan, Bioprocess capability days, Boston Imagination at work Presentation outline Introduction
More informationCapto * Blue and Capto Blue (high sub)
GE Healthcare Life Sciences Data file 28-9369-6 AC Affinity chromatography Capto * Blue and (high sub) and (high sub) are affinity chromatography media (resins) for the capture of human serum albumin,
More informationEvaluation of novel CEX resin for continous processing of MAb purification
Engineering Conferences International ECI Digital Archives Integrated Continuous Biomanufacturing II Proceedings Fall 11-2-2015 Evaluation of novel CEX resin for continous processing of MAb purification
More informationCellufine MAX HIC Butyl, Phenyl Technical Data Sheet
Hydrophobic Interaction Chromatography Media MAX HIC Butyl, Technical Data Sheet 2-1, temachi 2-Chome Chiyoda-ku, Tokyo 1-815 JAPAN Phone +81-3-323-615 / Fax +81-3-323-6219 e-mail: cellufine@jnc-corp.co.jp
More informationHow to reach high plasma protein concentration with Single-Pass TFF: A case study from Baxter and
How to reach high plasma protein concentration with Single-Pass TFF: A case study from Baxter and Merck Millipore Eric Youssef Asia and Europe Plasma Market Lead Merck Millipore Bioplasma World Asia 2014
More informationMimetic Blue Affinity Adsorbents Mimetic Blue 1 P6XL, Mimetic Blue SA P6XL Mimetic Blue SA HL P6XL, Mimetic Blue ELISA Kit
Mimetic Blue Affinity Adsorbents Mimetic Blue 1 P6XL, Mimetic Blue SA P6XL Mimetic Blue SA HL P6XL, Mimetic Blue ELISA Kit WWW.PROMETICBIOSCIENCES.COM/PRODUCT DATASHEET Mimetic Blue affinity chromatography
More informationFast Trak Services: a collaborative project to accelerate downstream biosimilar process development
GE Healthcare Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development A case study Case study, 2924332 AA Fast Trak Services A collaborative project to accelerate
More informationSimplicity is the key Continuous purification of monoclonal antibodies
Simplicity is the key Continuous purification of monoclonal antibodies L. Landric-Burtin Head of Downstream Processing Development, France Integrated Continuous Biomanufacturing Conference, Barcelona,
More informationA novel approach to Protein A capture chromatography to help decrease cost of clinical manufacturing and reduce supply chain risk
PRODUCT BULLETIN POROS MabCapture A resins A novel approach to Protein A capture chromatography to help decrease cost of clinical manufacturing and reduce supply chain risk Introduction As cell culture
More informationIntegrated Process Engineers & Constructors, Inc.
Integrated Process Engineers & Constructors, Inc. CORPORATE MISSION STATEMENT IPEC provides design, engineering, project management, fabrication, installation services and prepackaged modular systems through
More informationCapto Blue and Capto Blue (high sub)
Data file 28-9369-6 AD Affinity chromatography Capto Blue and (high sub) and (high sub) are affinity chromatography media (resins) for the capture of human serum albumin (HSA), as well as purification
More informationJefferies 2016 Healthcare Conference. June 8, 2016
Jefferies 2016 Healthcare Conference June 8, 2016 Safe Harbor This presentation contains forward looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities
More informationThe Contichrom Process Portfolio and Software Tools
The Contichrom Process Portfolio and Software Tools Superior twin column chromatography processes for chromatographic purification operated by Contichrom systems The Contichrom Process Portfolio The Contichrom
More informationPolishing of monoclonal antibodies using Capto S ImpAct
Application note 29-83-27 AA Ion exchange chromatography Polishing of monoclonal antibodies using Capto S ImpAct Capto S ImpAct chromatography medium (resin) is a strong cation exchanger (CIEX). The medium
More informationSingle-use technology and sustainability: quantifying the environmental impact
Single-use technology and sustainability: quantifying the environmental impact Bill Flanagan Director, Ecoassessment Center of Excellence, GE 1 November 2016 Imagination at work Agenda Biopharmaceutical
More informationOperating Instructions Heparin Mimetic Affinity
DexS Cellufine MAX DexS is a new chromatography resin incorporating Dextran sulfate polymer surface modification. This non-animal derived pseudo affinity ligand can be used instead of immobilized Heparin
More informationIon Exchange Chromatography Media. Cellufine IEX. Technical Data Sheet
Ion Exchange Chromatography Media IEX Technical Data Sheet 2-1, Otemachi 2-Chome Chiyoda-ku, Tokyo 1-815 JAPAN Phone +81-3-3243-615 / Fax +81-3-3243-6219 e-mail: cellufine@jnc-corp.co.jp web: http: //www.jnc-corp.co.jp/fine/en/cellufine/
More informationConsiderations for establishing a single use technology-based biological plant: Case Study
Considerations for establishing a single use technology-based biological plant: Case Study PDA Israel Single Use Equipment Tel Aviv, 7th May 2018 Nitzan Levy, Ph.D Tarom Applied Technologies The Israeli
More informationEnhancing Upstream and Downstream Process Methods Through Implementation of Single-Use Technologies. 06 February 2018
Enhancing Upstream and Downstream Process Methods Through Implementation of Single-Use Technologies 06 February 2018 Overview Single-use technology (SUT) is a rapidly evolving technology that focuses on
More informationColumn for High Performance,High-Binding Capacity Ion Exchange Chromatography:TSKgel SuperQ-5PW and Its Applications
ANALYSIS S e p a r a t i o n R e p o r t N o. 9 3 Column for High Performance,High-Binding Capacity Ion Exchange Chromatography:TSKgel SuperQ-5PW and Its Applications Table of Contents 1. Introduction
More informationCONTINUOUS MANUFACTURING FOR BIOLOGICS & VACCINES
CONTINUOUS MANUFACTURING FOR BIOLOGICS & VACCINES Sue Behrens ISPE Product Show Track 2, Session 3 September 26, 2018 Questions about Continuous Bioprocessing Why? What s next? 2 1 Sue Behrens - Intro
More informationCapto Q Capto ViralQ Capto S
GE Healthcare Data File 11-25-76 AD Ion exchange chromatography Capto ViralQ Capto Q and are strong ion exchange media for packed bed chromatography that increase speed and throughput in capture and intermediate
More informationAffinity purification using ÄKTA start
GE Healthcare Life Sciences Affinity purification using ÄKTA start Training cue card This protocol will help you understand the practical principles of affinity chromatography by taking you step-by-step
More informationEfficient concentration of a low-titer bovine IgG with high recovery in low volume
GE Healthcare Efficient concentration of a low-titer bovine IgG with high recovery in low volume This application note describes the design of circuits with low working volume, allowing for high concentration
More informationQ SepFast HighRes. DEAE SepFast TM HighRes S SepFast TM HighRes CM SepFast TM HighRes
Data sheet Q SepFast TM HighRes DEAE SepFast TM HighRes S SepFast TM HighRes CM SepFast TM HighRes 1. Introduction Q (DEAE, S, CM) SepFast HighRes is a group of strong anion exchange, weak anion exchange,
More informationProPac Elite WCX, 5 μm Particle, for Fast, High Resolution Protein and mab Analysis. July 2018
ProPac Elite WCX, 5 μm Particle, for Fast, High Resolution Protein and mab Analysis July 218 ProPac Elite WCX Acidic Variants Basic Variants 5µm Weak Cation Exchange Column Chemistry based on Thermo Scientific
More informationA Hands-On Guide to Ultrafiltration/ Diafiltration Optimization using Pellicon Cassettes
Application Note A Hands-On Guide to Ultrafiltration/ Diafiltration Optimization using Pellicon Cassettes In ultrafiltration (UF) tangential flow filtration (TFF) systems, operating parameter selection
More informationDownscaling Purification Processes for Biologics
Clearance Services Considerations in Downscaling Purification Processes for Biologics O-0280608 About BioReliance BioReliance Corporation is a leading provider of cost-effective contract services to the
More informationÄKTA avant Inspired to Äccelerate your process development. Anna Emilsson Global Product Manager
ÄKTA avant Inspired to Äccelerate your process development Anna Emilsson Global Product Manager Evolution of ÄKTA 1996-2010 2009/10 ÄKTA avant 2009 - ÄKTAmicro 2006 New ÄKTApurifier 2005 ÄKTAcrossflow
More informationChromatography column for therapeutic protein analysis
PRODUCT SPECIFICATIONS ProPac Elite WCX Column Chromatography column for therapeutic protein analysis Benefits Superior resolution power for proteins, monoclonal antibodies, and associated charge variants
More informationContinuous Processing Progress in Manufacturing
Cell World Conference, San Francisco, May 25-26 2017 Dr. Berthold Boedeker, Bayer AG, Biological Development Biologics at Bayer Regulatory support / drivers aof continuous processing Bayer s approach to
More informationUse of Fluidised bed chromatography for plasma fractionation. Karl McCann*, John Wu, Peter Gomme & Joseph Bertolini
Use of Fluidised bed chromatography for plasma fractionation Karl McCann*, John Wu, Peter Gomme & Joseph Bertolini Plasma Fractionation Industry Mature with well established processes Revenue growth -
More informationCapto Q. GE Healthcare. Media characteristics. High flow rates and low backpressure in large-scale columns
GE Healthcare Data File 11-25-76 AB Ion exchange chromatography Capto Q is a strong anion exchange medium for packed bed chromatography that allows increased speed and throughput in capture and intermediate
More informationApplication note. Purification of PEGlyated proteins with Contichrom
Application note Purification of PEGlyated proteins with Contichrom ChromaCon AG // Purification of PEGylated proteins with Contichrom // www.chromacon.ch // ver. May 2013 1 Summary The purification of
More informationTools and solutions for separation of charged mab variants
GE Healthcare Tools and solutions for separation of charged mab variants A biosimilar is an almost identical version of an originator product, but to attain regulatory approval, a comparable quality to
More informationGel filtration using ÄKTA start
GE Healthcare Life Sciences Gel filtration using ÄKTA start Training cue card This protocol will help you understand the practical principles of gel filtration by taking you step-by-step through the purification
More informationProcess economic simulation for scalable production of adenovirus
Process economic simulation for scalable production of adenovirus This application note discloses process economic modelling of a modern start-to-finish adenovirus production process. The novel process
More informationThe above media is designed to capture antibodies or other molecules of similar size.
Data sheet SepFast TM Capture Q (400, 500, 600) SepFast TM Capture DEAE (400, 500, 600) SepFast TM Capture S (400, 500, 600) SepFast TM Capture CM (400, 500, 600) 1. Introduction SepFast Capture Q, SepFast
More informationThe Eshmuno Chromatography Family of Resins
The Eshmuno Chromatography Family of Resins The perfect accessory for highly productive downstream purification EMD Millipore is a division of Merck KGaA, Damstadt, Germany Introduction For over 300 years,
More informationManufacturing throughput (the
B i op r o c e s s Technical Process Development s Impact on Cost of Goods Manufactured (COGM) Chae Han, Philip Nelson, and Amos Tsai Manufacturing throughput (the amount of material a plant can produce
More informationGelatin Sepharose. instructions
instructions Gelatin Sepharose Gelatin Sepharose 4B is gelatin coupled to Sepharose 4B by the cyanogen bromide method. Gelatin binds specifically to fibronectin, which is a high molecular weight glycoprotein
More informationScalability of Cadence Inline Concentrator Modules for Bovine IgG Processing
Application Note USD3004 Scalability of Cadence Inline Concentrator Modules for Bovine IgG Processing Catherine Casey, M.Sc., and Engin Ayturk, Ph.D., BioPharm Applications R&D . Introduction Pall s single-pass
More informationThermo Scientific HyClone Single-Use Bioreactor Products and Capabilities. Discovery Development Production
Thermo Scientific HyClone Single-Use Bioreactor Products and Capabilities Discovery Development Production Introduction Leading the way in Single-Use Bioreactors Since its introduction, the Thermo Scientific
More informationSeparation Science Built for Biopharma
Separation Science Built for Biopharma Pharma & Biopharma Tours 2016 The world leader in serving science Overview 1. Evolution of UHPLC built for biopharma Meet the family 2. What makes Vanquish different?
More informationTransferring a process to a contract
Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2010, Vol. 30 No. 4 www.ispe.org Copyright ISPE 2010 This article presents a process transfer case study and the significance
More informationCurrent Trends in Single Use Technologies: Future Developments Affecting Production
5 September 2016 Current Trends in Single Use Technologies: Future Developments Affecting Production Eric S. Langer President and Managing Partner, BioPlan Associates, Inc. 2275 Research Blvd, Suite 500
More information2 5 ADP Sepharose 4B. GE Healthcare Life Sciences
GE Healthcare Life Sciences Instructions 71-7092-00 AF Affinity chromatography 2 5 ADP Sepharose 4B 2 5 ADP Sepharose 4B interacts strongly with NADP + -dependent dehydrogenases. Selective elution with
More informationSOURCE 15HIC. GE Healthcare. SOURCE 15ETH, SOURCE 15ISO, SOURCE 15PHE, SOURCE 15PHE 4.6/100 PE (Tricorn ), Characteristics
GE Healthcare Data file 18-1128-86 AC High-performance hydrophobic interaction chromatography SOURCE 15HIC SOURCE 15ETH, SOURCE 15ISO, SOURCE 15PHE, SOURCE 15PHE 4.6/100 PE (Tricorn ), Resource ETH, Resource
More informationDexS-HbP. Technical Note Heparin Mimetic Affinity. Model Protein adsorption to Cellufine MAX DexS-HbP resin
DexS-HbP A new chromatography resin incorporating a dextran sulfate polymeric ligand, acting as a Heparin mimetic for isolation and purification of plasma proteins Dextran sulfate is a synthetic derivative
More informationMabSelect SuRe pcc. Medium characteristics. GE Healthcare. Affinity chromatography. Optimized for continuous chromatography applications
GE Healthcare Affinity chromatography MabSelect SuRe pcc MabSelect SuRe pcc affinity chromatography medium (resin) offers exceptional capacity at short residence time, making it well-suited for applications
More informationContinuous manufacturing moving towards real-time release. Creating innovations for the pharmaceutical industry. siemens.
Continuous manufacturing moving towards real-time release Creating innovations for the pharmaceutical industry siemens.com/pharma Strategic partnership Creative ideas and industry expertise A move to continuous
More information