Simplicity is the key Continuous purification of monoclonal antibodies
|
|
- Clemence Boyd
- 6 years ago
- Views:
Transcription
1 Simplicity is the key Continuous purification of monoclonal antibodies L. Landric-Burtin Head of Downstream Processing Development, France Integrated Continuous Biomanufacturing Conference, Barcelona, 2013
2 mabs manufacturing processes have reached a good level of maturity Experience Cell line platforms High titers in cell culture Purification platforms Single use QbD Capacity Demand 2
3 But our manufacturing processes are still.. COMPLEX! LONG! EXPENSIVE! 3
4 Equilibration buffer #1 Wash buffer #1 Elution buffer #1 COMPLEX. ph, concentration adjustment, sampling OPERATOR INTERVENTION HOLD TIME OPEN PHASE OPEN PHASE Sampling & Storage OPERATOR INTERVENTION Equilibration buffer #2 Wash buffer #2 Elution buffer #2 HOLD TIME OPEN PHASE Sampling & Storage Bulk Harvest 0.2 µm filtration 0.2 µm filtration Protein A OPERATOR INTERVENTION OPEN PHASE Low ph & Neutralization Equilibration buffer #3 Wash buffer #3 Sampling & Storage OPERATOR INTERVENTION HOLD TIME OPEN PHASE Chrom2 Sampling & Storage OPERATOR INTERVENTION HOLD TIME OPEN PHASE ph, conductivity adjustment Chrom3 Nanofiltration TFF & storage 7 different Contaminations, buffers Human errors 4 7 consecutives, discontinued steps (12 incl. storage)
5 LONG, DISCONTINUED. Processing time (hr) Around 50 hr to complete the purification process Interruption between steps for concentration, ph or conductivity adjustement and storage. «n» step cannot start before completion of «n-1» 5
6 EXPENSIVE. 100 /gr Chromatography resin = 30 to 75 % of DSP costs. 6
7 COMPLEX, LONG, EXPENSIVE... Any solution? 7
8 SIMPLIFY, SIMPLIFY, SIMPLIFY. SIMPLICITY is key to get a quick, reliable and cheap process. 8
9 Simplicity & Purification of Mabs? 9
10 Let s go back to the essentials Equilibration buffer #1 Wash buffer #1 Elution buffer #1 ph, concentration adjustment, sampling Sampling & Storage Equilibration buffer #2 Wash buffer #2 Elution buffer #2 Sampling & Storage Bulk Harvest 0.2 µm filtration 0.2 µm filtration Protein A Low ph & Neutralization Chrom2 Equilibration buffer #3 Wash buffer #3 Sampling & Storage Sampling & Storage ph, conductivity adjustment Chrom3 Nanofiltration TFF & storage 10
11 Simplicity means NO inter-step ADJUSTMENT. We have selected resins that afford no inter-step adjustment. 11
12 Simplicity means FEW BUFFERS. We have imagined a buffer strategy composed of only 3 components for the entire process. 12
13 Simplicity means FEW BUFFERS. 4 buffers in total, ensuring ph and conductivity compatibility between all steps. 13
14 How simplicity looks like. 14
15 SIMPLE. Bulk Harvest Equilibration buffer #1 Wash buffer #1 Elution buffer #1 Equilibration buffer #1 Elution buffer #2 Wash buffer #1 Sampling & Storage Low ph Protein A Mixed mode AEX Nanofiltration TFF & storage 4 different buffers 6 steps (7 incl. storage), 4 being continuous. 15
16 Can a simplified process make the job? Clarified supernatant Protein A Mixed-mode AEX High Molecular Weight species 8.7 % 1.0 % 0.2 % 0.2 % Host Cell Proteins 2.2E+05 ppm 800 ppm 40 ppm 5 ppm Host Cell DNA 3E+06 ppb 2E+04 ppb 10 ppb < 0.1 ppb Endotoxins < 0.05 EU/mL along the process Overall yield 90 % 16
17 Can a simplified process be a platform? Isoelectric point Project 2 Yield : 89% Project 3 Yield : 92% Project 1 Yield : 93% Project 4 Yield : 94% Project 5 Yield : 86% 5 Successfully evaluated on 5 different projects without optimization. 17
18 Simplicity advantages 18
19 SIMPLIFIED PROCESS GAINS reduced our process time: 2X higher per-hour productivity. reduced number of buffers: 30 % cost saving on buffers. 19
20 SIMPLIFIED PROCESS GAINS Continuous manufacturing with no human handling. Reduced risk of contamination Reduced sampling plan Reduced storage needs Possibility to run the process in a multicycle mode. 20
21 SIMPLE. Bulk Harvest Equilibration buffer #1 Wash buffer #1 Elution buffer #1 Equilibration buffer #1 Elution buffer #2 Wash buffer #1 Sampling & Storage Low ph Protein A Mixed mode AEX Nanofiltration TFF & storage 4 different buffers 6 steps (7 incl. storage), 4 being continuous. 21
22 SIMPLE, SMALL and AUTOMATED. Bulk Harvest Equilibration buffer #1 Wash buffer #1 Elution buffer #1 Equilibration buffer #2 Run X Elution buffer #2 Wash buffer #1 Sampling & Storage Run 3 Run 2 Run 1 Protein A Low ph Mixed mode AEX Nanofiltration TFF & storage We have automated the process to run it in multi cycles with small columns. 22
23 ASAP process gains. Batch Mode Continuous Multi-cycling 66% of resin volume saved for an equivalent batch duration. Up to 97% for > duration. Perfect application for disposable columns. No packing Full use of resin lifetime No storage 23
24 SIMPLE, SMALL and CHEAP. Batch Mode Continuous Multi-cycling Smaller systems and facilities. Limited staff requested. 24
25 SIMPLE, SMALL and PRODUCTIVE 14.1 L resin, 4 cycles prot A, (24 hr* to 72h duration) 1 m3 Bulk Harvest Productivity : 2.7 g/l/hr* 1.2 L resin - 47 cycles - 71 hrs duration (*):with shift work Productivity : 10.5 g/l/hr 25
26 SIMPLE and ADAPTATIVE Adapt your column size to your requirements 50 hr Processing time X hr High product needs, facility constraints: Big columns to process rapidely one batch 0 << 100 /g ~100 /g Cost constraint: Small columns to decrease resin costs and optimize resin lifetime Batch cost 26
27 CASE STUDY: Continuous purification at lab scale 50 or 100 ml resin volume 70 L of buffers 43 L of supernatant 27
28 CASE STUDY: Continuous purification at lab scale 43 L of supernatant fully purified continuously in 69h : 45 runs performed automatically. 67g of purified mab collected 93% yield X3 24 ml min Charge 40min X9 (1012)001:10_UV1Col1 X3 24 ml min Charge 40min X9 (1012)001:10_UV1Col2 X3 24 ml min Charge 40min X9 (1012)001:10_UV1Col3 X3 24 ml min Charge 40min X9 (1012)001:10_Logbook mau X3 24 ml min Charge 40min X9 (1012)001:10_UV1Col1 X3 24 ml min Charge 40min X9 (1012)001:10_UV1Col2 X3 24 ml min Charge 40min X9 (1012)001:10_UV1Col3 X3 24 ml min Charge 40min X9 (1012)001:10_Logbook mau 3000 mau mau min min 0 28
29 SCALE UP and GMP compliance evaluation (On-going) 500 L batch Final target : > 1Kg of purified mab Column < 10L < 10 runs with a final duration of 16h 29
30 CONCLUSION If you seek for quick, reliable and cheap process, get the superfluous off your process. Starting from this perspective, we have designed - a simplified purification platform, - able to run continuously, - with 4 fold increase in productivity - significant gain on resin cost. 30
31 and excellent staff Simplicity is the key Continuous purification of monoclonal antibodies Special thanks to: Benoit MOTHES Didier DUTHE Céline HEMET 31
32 32
Evaluation 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 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 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 informationBPI.Seminar Semina opelmg ropelmg.com com
Send questions to: BPI.Seminars@propelmg.com Moving to the next level of Manufacturing Oct 14 th 2009 BPI Raleigh Rolf Douwenga VP Global Research and Development DSM Biologics. DSM CONFIDENTIAL FL15 Agenda
More informationPresented at the ECI Conference on Integrated Continuous Biomanufacturing Castelldefels, Spain, October 21, 2013
Continuous Antibody Capture with Protein A Countercurrent Tangential Chromatography: A New Column-Free Approach for Antibody Purification Andrew L. Zydney Department Head and Walter L. Robb Family Chair
More informationFastPure Spin Columns (Mini and Midi)
G-Biosciences 1-800-628-7730 1-314-991-6034 technical@gbiosciences.com A Geno Technology, Inc. (USA) brand name FastPure Spin Columns (Mini and Midi) (Cat. # 786-1088, 786-1089, 786-1090, 786-1091) think
More informationHigh Throughput Screening Technologies for developing purification processes of proteins. Michel Eppink, Synthon BV, Nijmegen
High Throughput Screening Technologies for developing purification processes of proteins Michel Eppink, Synthon BV, Nijmegen Introduction Overview From small to large processes New protein purification
More informationLFB BIOMANUFACTURING YOUR CDMO PARTNER FOR MABS AND RECOMBINANT PROTEINS B IOMANUFACTURING
YOUR CDMO PARTNER FOR MABS AND RECOMBINANT PROTEINS B IOMANUFACTURING COMMITMENT AND FLEXIBILITY LFB BIOMANUFACTURING is a medium-sized CDMO offering Bioproduction services, from an industrial facility
More informationHyperCel STAR AX Ion Exchange Sorbent
USD 2831(2) HyperCel STAR AX Ion Exchange Sorbent Salt Tolerant Advanced Recovery Anion Exchange Chromatography Sorbent An industry-scalable anion exchange chromatography sorbent designed for high productivity
More informationDownsizing downstream processing: A novel single-use purification platform for biologics
Downsizing downstream processing: A novel single-use purification platform for biologics James Stout, PhD VP, Process Sciences BPI Boston, October 2015 Natrix Separations Inc. Burlington, Ontario, Canada
More informationCapture of mouse monoclonal antibodies
Capture of mouse monoclonal antibodies by cation exchange chromatography Life Science Products Processing Capture of mouse monoclonal antibodies from cell culture supernatant by cation exchange chromatography
More informationDownstream Processing (DSP): Microscale Automation of Biopharmaceutical Processes. Michel Eppink, Synthon BV, Nijmegen, The Netherlands
Downstream Processing (DSP): Microscale Automation of Biopharmaceutical Processes Michel Eppink, Synthon BV, Nijmegen, The Netherlands Overview Introduction Why automation? Automation in DSP processes
More informationTable 1, Performance characteristics of Cellufine SPA-HC
SPA-HC An affinity chromatography resin designed for the isolation of immunoglobulins, including monoclonal antibodies (mab) from complex matrices, such as cell culture supernatant and serum/plasma. Cellufine
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 informationA novel multimodal anion exchanger designed for monoclonal antibody purification
A novel multimodal anion exchanger designed for monoclonal antibody purification IBC s 18th International, Antibody Development &Production February-March, 2007 Hans J Johansson, Anders Ljunglöf, Kjell
More informationKelly Thom Associate Principal Scientist Fujifilm Diosynth Biotechnologies. Your Biologics and Vaccines CDMO Partner of Choice.
Process Design for an All Single-Use Manufacturing Facility: Scaling Low to High Titer Processes to Fit Standard mab Equipment BioProcess International West March 2, 2017 Kelly Thom Associate Principal
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 informationTraining Program 2019
www.bcc.ch info@bcc.ch Biofactory Competence Center SA Passage du Cardinal 13b 1700 Fribourg (CH) Training Program 2019 Training is delivered by subject matter experts from both academia and those with
More information1. Connect the column to the chromatography system, syringe or pump.
BabyBio TREN INSTRUCTIONS IN 45 655 030 The ready-to-use BabyBio TREN columns are prepacked with WorkBeads 40 TREN resin and are available in two column sizes, 1 ml and 5 ml. WorkBeads 40 TREN resin for
More informationAdsorptive and Mechanical Mechanisms of Fluid Purification Using Charge Modified Depth Filtration Media. Dr. Robert Conway, Ph.D.
Adsorptive and Mechanical Mechanisms of Fluid Purification Using Charge Modified Depth Filtration Media Dr. Robert Conway, Ph.D. Depth Filter Cartridge Construction Zeta Plus Media Materials of Construction
More informationHyperCel STAR AX Ion Exchange Sorbent
USD 28312a HyperCel STAR AX Ion Exchange Sorbent Salt Tolerant Advanced Recovery Anion Exchange Chromatography Sorbent An industry-scalable anion exchange chromatography sorbent designed for high productivity
More informationThe use of Chromatography Membranes for the development and production of biopharmaceuticals.
The use of Chromatography Membranes for the development and production of biopharmaceuticals. Dr. Juan Pablo Acosta Martinez Project Manager. Virus and Contaminant Clearance Sartorius Stedim Biotech Agenda
More informationPhenyl Membrane Adsorber for Bioprocessing
Phenyl Membrane Adsorber for Bioprocessing Sartobind Hydrophobic Interaction Membrane Chromatography The low substitution of the phenyl ligand on the membrane allows for mild elution of biomolecules such
More information0E.03. profos AG. creative bioscience solutions. product information. creative bioscience solutions
0E.03 profos AG profos AG is a reliable and steadily growing biotechnology company. The combination of science, creativity and versatility under the paradigm of efficiency are our philosophy. Our products
More informationOptimization of ADC Process Development. Eric LACOSTE PhD, Chemistry and Biotechnology Development Sanofi Aventis R&D, Vitry sur Seine, France 2016
Optimization of ADC Process Development Eric LACOSTE PhD, Chemistry and Biotechnology Development Sanofi Aventis R&D, Vitry sur Seine, France 2016 Strictly confidential do not distribute without prior
More informationSubject Index. chromatography step, 125-
A Alert limits, description, 70 Aluminum hydroxide based vaccine manufacture, start up and validation of sterile formulation and filling processes, 144-168 Anion-exchange chromatography step for clinical-grade
More informationGORE. Protein Capture Devices. Operating Instructions Contents. Product Description Device Characteristics... 2 General Handling...
GORE Protein Capture Devices Operating Instructions Contents Product Description............................... 2 Device Characteristics............................. 2 General Handling................................
More informationFavorPrep Endotoxin-Free Plasmid DNA Extraction Maxi Kit. User Manual
TM FavorPrep Endotoxin-Free Plasmid DNA Extraction Maxi Kit User Manual Cat. No.: FAPDE 003-EF (10 Preps) For Research Use Only v.1005-1 Introduction TM The FavorPrep Endotoxin-Free Plasmid DNA Extraction
More informationSubject Index. See for options on how to legitimately share published articles.
Downloaded via 148.251.232.83 on March 27, 2019 at 03:59:27 (UTC). See https://pubs.acs.org/sharingguidelines for options on how to legitimately share published articles. A Alert limits, description, 70
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 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 informationImmobilized Streptavidin Resin
438PR-01 G-Biosciences 1-800-628-7730 1-314-991-6034 technical@gbiosciences.com A Geno Technology, Inc. (USA) brand name Immobilized Streptavidin Resin (Cat. # 786-390, 786-590, 786-591, 786-592) think
More informationEmerging and Enabling Technologies in Membrane Separations
Emerging and Enabling Technologies in Membrane Separations Andrew L. Zydney Distinguished Professor of Chemical Engineering The Pennsylvania State University 2 nd International Symposium on Continuous
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 informationSartobind IEX nano 3 ml
Operating Instructions Sartobind IEX nano 3 ml A Separation Technology Based on Macroporous Membranes, 8 mm Bed Height 85032-536-01 Information Please read the operation instruction carefully before using
More informationDynamic High Capacity Mustang Q Membrane Units for Scaleable Anion Exchange Chromatography Purification of Adenoviral Vectors
Contact Us: www.pall.com/contact Dynamic High Capacity Mustang Q Membrane Units for Scaleable Anion Exchange Chromatography Purification of Adenoviral Vectors Dynamic High Capacity Mustang Q Membrane Units
More informationImproving Downstream Manufacturing Productivity with Pre-Packed Chromatography Columns
Improving Downstream Manufacturing Productivity with Pre-Packed Chromatography Columns Michael Dittmer MedImmune, BioProcess Engineering BPI West, San Francisco, CA March 2 nd, 2017 Outline Motivation
More informationPhenyl Membrane Adsorber for Bioprocessing
Phenyl Membrane Adsorber for Bioprocessing Sartobind Hydrophobic Interaction Membrane Chromatography The low substitution of the phenyl ligand on the membrane allows for mild elution of biomolecules such
More informationYour complete protein clean-up toolbox
Your complete protein clean-up toolbox Thermo Scientific protein sample clean-up devices have evolved over the last decade to meet a variety of customer needs. Our broad portfolio of high-performance tools
More informationDisposable devices for unit
D I S P O S A B L E S DOWNSTREAM Disposable Membrane Chromatography Performance Analysis and Economic Cost Model by Jeff Mora, Andrew Sinclair, Noushin Delmdahl, and Uwe Gottschalk Disposable devices for
More information2013 Protein BioSolutions, Inc. All rights reserved. page 1
page 1 Overview Purify 1 to 24 samples in parallel Eliminate known and unknown (!) sample degradation mg+ protein production scale Flexible sample volume scales from a few ml to multiple liters 24 x 1
More informationThe practical task of monoclonal IgG purification with CHT TM ceramic hydroxyapatite
The practical task of monoclonal IgG purification with CHT TM ceramic hydroxyapatite Pete Gagnon, Jie He, Paul Ng, Julia Zhen, Cheryl Aberin, Heather Mekosh 11th Annual Waterside Conference, Chicago, May
More informationProcess Removal of Impurities in Biotech Products
Process Removal of Impurities in Biotech Products CASSS Midwest Regional Forum October 5, 2017 Warren R. Emery Sr. Research Scientist Bioproduct R&D, Eli Lilly and Company Pharmaceutical Process Development
More informationMulti-column Continuous Capture Chromatography New data confirming significant savings and de-bottlenecking opportunities
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,
More informationMabSelect SuRe. GE Healthcare. Alkali-stabilized protein A-derived medium for capture of monoclonal antibodies. High stability in alkaline conditions
GE Healthcare Data File 11-11-65 AB Affinity chromatography MabSelect SuRe Alkali-stabilized protein A-derived medium for capture of monoclonal antibodies MabSelect SuRe (Superior Resistance) is a member
More informationPlasmid DNA Extraction Midiprep Kit
BIO BASIC Plasmid DNA Extraction Midiprep Kit 9K-006-0027s (1 prep) 9K-006-0027 (25 preps) Toll Free 1-877-956-7778 ForOrder Research Use Only www.feldan.com 1 Index Plasmid DNA Extraction Midiprep Kit
More informationApplication Note. Rapid optimisation and development of an automated two-step purification procedure for monoclonal IgG antibodies.
Rapid optimisation and development of an automated two-step purification procedure for monoclonal IgG antibodies Application Note ÄKTAFPLC Convenient and rapid standard purification protocol for monoclonal
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 information3. Close the bottom end of the column and apply the packing device on top. Pump water through the upper adaptor to remove air.
INSTRUCTIONS FOR USE WorkBeads Protein A Product name Pack size Article number WorkBeads Protein A Bulk Media 1.5 ml 40605001 Bulk Media 5 ml 40605002 Bulk Media 10 ml 40605003 Bulk Media 100 ml 40605004
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 informationProteoSpin Total Protein Concentration, Detergent Clean-Up and Endotoxin Removal Mini Kit Product Insert Product # 22800
3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: 866-667-4362 (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com ProteoSpin Total Protein Concentration, Detergent Clean-Up and
More informationOperational & Economic Evaluation of Integrated Continuous Biomanufacturing Strategies for Clinical & Commercial mab Production
UCL Decisional Tools Research Operational & Economic Evaluation of Integrated Continuous Biomanufacturing Strategies for Clinical & Commercial mab Production Suzanne Farid PhD CEng FIChemE Reader (Associate
More informationNonionic Polymer Enhancement of Aggregate Removal in Ion Exchange
Nonionic Polymer Enhancement of Aggregate Removal in Ion Exchange and Hydroxyapatite Chromatography Pete Gagnon, Richard Richieri, Simin Zaidi 12th Annual Waterside Conference, San Juan, Puerto Rico, April
More informationIon Exchange Chromatography. Learning Objectives:
Proteomics Ion Exchange Chromatography Ion Exchange Chromatography Ion exchange chromatography is a purification technique, which involves the separation of the proteins based on the ion exchange property
More informationRhinophase -AB, Zirconia-based Monoclonal Antibody Purification System
Rhinophase -AB, Zirconia-based Monoclonal Antibody Purification System Welcome to the sixth issue of ZirChrom's electronic newsletter. This newsletter introduces a biocompatible stationary phase useful
More informationAn effective platform for purification of IgM monoclonal antibodies using Hydroxyapatite
An effective platform for purification of IgM monoclonal antibodies using Hydroxyapatite Frank Hensel, Patrys, GmbH Pete Gagnon, Validated Biosystems 5th International Conference on Hydroxyapatite and
More informationAb SpinTrap Ab Buffer Kit
GE Healthcare Data File 28-9020-30 AB Protein Sample Preparation Ab SpinTrap Ab Buffer Kit The Ab SpinTrap and the Protein G HP SpinTrap are identical columns. The difference between the article numbers
More informationPurification of lambda Fab Characterization of a new affinity chromatography resin
Characterization of a new affinity Linus Laurin, Maria Ersoy and Pia Thunman GE Healthcare Bio-Sciences AB, Uppsala, Sweden First presented at the Next Generation Protein Therapeutics Summit, in San Francisco,
More informationmab Titer Analysis with the Agilent Bio-Monolith Protein A Column
mab Titer Analysis with the Agilent Bio-Monolith Protein A Column Application Note Biopharmaceuticals and Biosimilars Authors Emmie Dumont, Isabel Vandenheede, Pat Sandra, and Koen Sandra Research Institute
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 informationPurite Water Purification Systems
SELECT WATER PURIFICATION Water Purification The Select range of high performance water purification systems offers a unique combination of reliability, quality and functionality for all laboratory applications.
More informationProduct # Specifications. Kit Specifications Column Binding Capacity 25 µg
3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: 866-667-4362 (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com BAC DNA MiniPrep Kit Product # 18000 Product Insert The BAC DNA
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 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 informationNext-generation, high-capacity, alkalistable
Evaluation of a Next-Generation Protein A Chromatography Resin for the Purification of Monoclonal Antibodies Bryan Dransart, April Wheeler, Tony Hong, Chi Tran, Rafael Abalos, Andrew Quezada, ShiYu Wang,
More informationProtein purification and bioprocessing MINIATURE PARALLEL AUTOMATED
Protein purification and bioprocessing MINIATURE PARALLEL AUTOMATED 2 Parallel chromatography in columns OPUS ROBOCOLUMNS CHROMATOGRAPHY MINIATURIZED Combining Repligen s miniaturized chromatography columns
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 informationChromatographic Workflows for Biopharmaceutical Characterization
Chromatographic Workflows for Biopharmaceutical Characterization Dr. Ken Cook European Bioseparation Sales Support Expert Thermo Fisher Scientific, Hemel Hempstead/Germany The world leader in serving science
More informationOperational & Economic Evaluation of Integrated Continuous Biomanufacturing Strategies for Clinical & Commercial mab Production
UCL Decisional Tools Research Operational & Economic Evaluation of Integrated Continuous Biomanufacturing Strategies for Clinical & Commercial mab Production Suzanne Farid PhD CEng FIChemE Reader (Associate
More informationProteoSpin CBED (Concentration, Buffer Exchange and Desalting)
344 Merritt Street St. Catharines, ON, Canada L2T 1K6 Phone: 866-667-4362 (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com ProteoSpin CBED (Concentration, Buffer Exchange and Desalting)
More informationUsing a BioCel System and AssayMap Technology in Phage Display and Antibody Screening. Jason Graves September 20, 2011 AAS User Group Meeting
Using a BioCel System and AssayMap Technology in Phage Display and Antibody Screening Jason Graves September 20, 2011 AAS User Group Meeting My Background 15 Years of Automation and Related Experience
More informationThe Braine BioPilot An Integral Part of Bioprocess Development for Cell Culture- Based Biologics
The Braine BioPilot An Integral Part of Bioprocess Development for Cell Culture- Based Biologics Visit of Alabama Biotech Oct 2014 Alain BERNARD Vice President GPS, UCB Technical Operations Tech Ops BioTech
More informationMBP Excellose handbook - Purification of MBP fusion proteins -
Introduction MBP Excellose handbook - Purification of MBP fusion proteins - MBP Excellose is a affinity chromatography medium used for simple and rapid purification of MBP (maltose binding protein) fusion
More informationScreenExpert RoboColumn
USD2992 (1) For High Throughput Chromatography Sorbent Screening and Optimization s are miniaturized chromatography columns pre-packed with Pall chromatography sorbents. They are designed for fully automated
More informationSERVA BluePrep Protein EndotoxinEx Macro Kit
INSTRUCTION MANUAL SERVA BluePrep Protein EndotoxinEx Macro Kit (Cat. No. 42086.01) 1 Contents 1. SERVA BluePrep Protein EndotoxinEx Macro Kit 3 1.1. Kit Components 3 1.2. Specifications 4 1.3. Storage
More informationPROCEDURE FOR USE NICKEL NTA Magnetic Agarose Beads (5%)
1 AFFINITY HIS-TAG PURIFICATION PROCEDURE FOR USE NICKEL NTA Magnetic Agarose Beads (5%) DESCRIPTION Nickel NTA Magnetic Agarose Beads are products that allow rapid and easy small-scale purification of
More informationI-Blue Midi Plasmid Kit. I-Blue Midi Plasmid Kit. (Endotoxin Free) IBI SCIENTIFIC. Instruction Manual Ver For Research Use Only.
Instruction Manual Ver. 05.11.17 For Research Use Only I-Blue Midi Plasmid Kit & I-Blue Midi Plasmid Kit (Endotoxin Free) IB47180, IB47190 (2 Preparation Sample Kit) IB47181, IB47191 (25 Preparation Kit)
More informationNatriFlo HD-Q Data File
NatriFlo HD-Q Data File Executive Summary The NatriFlo HD-Q Membrane is an advanced material with a three-dimensional macroporous hydrogel structure that provides High Density of binding sites and rapid
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 informationCapture of human single-chain Fv (scfv) fusion protein on Capto L affinity medium
GE Healthcare Life Sciences Application note 29-0144-56 AA Affinity chromatography Capture of human single-chain Fv (scfv) fusion protein on Capto L affinity medium We describe the capture of a single-chain
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 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 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 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 informationViral Clearance Studies
Viral Clearance Studies viral clearance studies from the industry leader with unmatched experience and expertise Viral clearance is a critical component of regulatory submissions as it helps demonstrate
More informationPhosPRO Phosphoprotein Purification Kit
Manual PhosPRO Phosphoprotein Purification Kit PP0-2C/PP0-6C/PP0-E V2.0 Store at 2-8 C For Research Use Only Introduction PhosPRO Phosphoprotein Purification Kit is a new version of immobilized metal affinity
More informationTechnical Manual No Update date
ToxinEraser TM Endotoxin Removal Kit Cat. No. L00338 Technical Manual No. 0312 Update date 08032009 I Description.. 1 II Key Features.... 2 III Kit Contents. 2 IV Materials and Equipment Needed but not
More informationFigure 1: E. Coli lysate transfer using liquid handling automation
Figure 1: E. Coli lysate transfer using liquid handling automation Figure 1 - E. coli lysate transfer using liquid handling automation. Following the manufacturer s procedures, a 96-well plate miniprep
More informationPhosPRO Phosphoprotein Enrichment Kit
Manual PhosPRO Phosphoprotein Enrichment Kit PP03-2C/PP03-6C/PP03-E V2.0 Store at 2-8 C For Research Use Only Introduction Visual Protein provides a new version of immobilized metal affinity chromatography
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 informationJapanese Application Form: PMDA s Perspective on Manufacturing Process Description
Japanese Application Form: PMDA s Perspective on Manufacturing Process Description Reiko YANAGIHARA, Ph.D. Principal Reviewer Division of Pharmacopoeia and Standards for Drugs Office of Standards and Guideline
More informationSeparation of Monoclonal Antibodies Using TSKgel HPLC Columns
ANALYSIS S e p a r a t i o n R e p o r t N o. 7 4 Separation of Monoclonal Antibodies Using TSKgel HPLC Columns Table of Contents 1. Introduction 1 2. Separation Mode and Purification Method 1 3. Applications
More informationBuilding the Vaccine Manufacturing Platforms of the Future: Disposable Manufacturing. Mats Lundgren, PhD GE Healthcare Life Sciences
Building the Vaccine Manufacturing Platforms of the Future: Disposable Manufacturing Mats Lundgren, PhD GE Healthcare Life Sciences Introduction 2 Why use disposables in vaccine production? Vaccines often
More informationChallenges in Scaling Up Newly Developed Microbial Manufacturing Processes
Challenges in Scaling Up Newly Developed Microbial Manufacturing Processes Susan Dana Jones, Ph.D. BioProcess Technology Consultants BIO Process Zone Theater June 19, 2008 Microbial Process Development
More informationTo be Continuous or Discontinuous, that is the Question
E2E Integrated Continuous Manufacture of Therapeutic Proteins: Key Technologies Needed and Lessons Learned To be Continuous or Discontinuous, that is the Question Charles L. Cooney Robert T. Haslam (1911)
More information50 g 650 L. *Average yields will vary depending upon a number of factors including type of phage, growth conditions used and developmental stage.
3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: 866-667-4362 (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com Phage DNA Isolation Kit Product # 46800, 46850 Product Insert
More informationGE Healthcare. ÄKTAxpress protein purification that keeps pace with your research
GE Healthcare ÄKTAxpress protein purification that keeps pace with your research Keeping pace with today s purification challenges ÄKTAxpress TM is a complete, intelligent, and robust solution for multidimensional
More informationPrimary Clarification Step Evaluation
Primary Clarification Step Evaluation Implementation of 3M Technologies During Transition to Late Stage Process Development Page 1 03/01/2017 / Mark Shannon, Development Scientist / BPI West 2017 Agenda
More informationIntroduction to TFF. Sengyong Lee Ph.D. Professor/ Program Chair Biotechnology/ Biology Ivy Tech Community College Bloomington, Indiana
Introduction to TFF Sengyong Lee Ph.D. Professor/ Program Chair Biotechnology/ Biology Ivy Tech Community College Bloomington, Indiana Main Agenda Biomanufacturing and Filtration Filtration Principles
More informationVirus Filtration for Biosimilars : From needs to Solutions
Virus Filtration for Biosimilars : From needs to Solutions 3 rd International Conference and Exhibition on Biowaivers, Biologics and Biosimilars - Hyderabad Tathagata Ray Layout of Presentation 1 Virus
More information