Presented at the ECI Conference on Integrated Continuous Biomanufacturing Castelldefels, Spain, October 21, 2013

Size: px
Start display at page:

Download "Presented at the ECI Conference on Integrated Continuous Biomanufacturing Castelldefels, Spain, October 21, 2013"

Transcription

1 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 Department of Chemical Engineering The Pennsylvania State University Presented at the ECI Conference on Integrated Continuous Biomanufacturing Castelldefels, Spain, October 21, 2013

2 Continuous Bioprocessing Significant potential opportunities Reduced capital costs / facility requirements Higher productivity Easier scale-up Major technology developments in place Perfusion bioreactors In-line filters Critical challenge is chromatography

3 Chromatography Options Multi-column periodic counter-current chromatography (PCC) GE Healthcare Simulated moving bed chromatography (SMB) Semba, Tarpon, Contichrom Sequential multi-column chromatography (SMCC) Novasep These approaches typically do not provide truly steady-state operation, potentially leading to variability in product quality

4 Example: SMB New Developments in Simulated Moving Bed Chromatography Seidel-Morgenstern, Kessler, and Kaspereit Chemical Engineering Technology, 31: 826 (2008)

5 Objectives Develop and demonstrate a new technology that can provide truly continuous protein purification using available chromatography resins, e.g., Protein A Design criteria: Comparable yield and purity to columns High productivity (10x packed columns) Single use capability (no stainless steel)

6 Countercurrent Tangential Chromatography - CTC Chromatographic resin (beads) flows as a slurry through a series of static mixers and hollow fiber membrane modules All operations (binding, washing, elution, stripping, equilibration) performed directly on the slurry Countercurrent staging used to reduce buffer and resin requirements, increase product yield and purity

7 Continuous CTC System Slurry Tank Binding Washing Elution Stripping Regnera -tion Waste Waste Feed Tank Product Tank Waste Waste True moving bed Conveyor like process Resin slurry moves counter-currently to buffer in each step

8 Chromatographic Stage Koflo static mixer + Spectrum hollow fiber module Provides residence time needed for equilibration in binding and elution steps Excellent radial mixing with minimal pressure drop Provides complete separation between resin particles and fluid phase High single pass conversion with low pressure losses

9 Continuous CTC System Centrate Feed Wash 1 Buffer Wash 2 Buffer Elution Buffer Stripping Buffer Equilibra -tion Buffer Resin Tank Binding Wash 1 Wash 2 Elution Stripping Equilibration UF Step Binding Permeate Wash 1 Permeate Wash 2 Permeate Stripping Permeate Equilibra -tion Permeate Product Tank UF Permeate

10 Countercurrent Staging - Elution Stage 1 Stage 2 Resin Slurry to Strip Washing Resin Slurry from Wash 1 st stage 2 nd stage ph 3 Elution Buffer Purified mab

11 Countercurrent Staging - Elution Stage 1 Stage 2 Resin Slurry to Strip Washing Resin Slurry from Wash 1 st stage 2 nd stage ph 3 Elution Buffer Purified mab

12 Countercurrent Staging - Elution Stage 1 Stage 2 Resin Slurry to Strip Washing Resin Slurry from Wash 1 st stage 2 nd stage ph 3 Elution Buffer Purified mab

13 Countercurrent Staging - Elution Stage 1 Stage 2 Resin Slurry to Strip Washing Resin Slurry from Wash 1 st stage 2 nd stage ph 3 Elution Buffer Purified mab

14 Countercurrent Staging - Elution Stage 1 Stage 2 Resin Slurry to Strip Washing Resin Slurry from Wash 1 st stage 2 nd stage ph 3 Elution Buffer Purified mab

15 Example: 3-Stage Elution Step Concentrated slurry with bound product Elution Buffer Static mixer Tangential flow filter P P R Tangential flow filter Static mixer R P Static mixer Tangential flow filter R Product Concentrated resin slurry

16 Effect of Staging Elution Step Number of stages Experimental yield Theoretical yield 1 78 ± 2% 77% 2 94 ± 2% 94% 3 98 ± 1% 98% Results for q p / q r = 0.75 q p = permeate flow rate q r = retentate flow rate n = number of stages From Shinkazh et al., Biotech. Bioeng, 108: 582 (2011)

17 Experimental System Clarified cell culture fluid (Fujifilm Diosynth) Monoclonal antibody product POROS MabCapture A resin Life Technologies 45 µm diameter particles, Protein A ligand MidiCros hollow fiber modules - Spectrum Lab 0.5 µm PES membranes, 1 mm ID, 200 cm 2 area Static mixers Koflo Corportation 29 cm length, 1 cm ID

18 Critical Filtrate Flux Transmembrane Pressure, TMP (psi) Feed: 10% slurry, 100 ml/min TMP Flux Filtrate Flux, J v (L m -2 hr -1 ) Time, t (s)

19 Critical Filtrate Flux Transmembrane Pressure, TMP (psi) Feed: 10% slurry, 100 ml/min TMP Flux Critical Flux Filtrate Flux, J v (L m -2 hr -1 ) Critical flux corresponds to 80% conversion using 10% slurry Time, t (s)

20 Critical Filtrate Flux Transmembrane Pressure, TMP (psi) Feed: 10% slurry, 100 ml/min TMP Flux Critical Flux Operating Flux Filtrate Flux, J v (L m -2 hr -1 ) Critical flux corresponds to 80% conversion using 10% slurry System design: 7.5% slurry 75% conversion Extra safety limit enables stable operation for long times Time, t (s)

21 CTC Process using Protein A Operation Numbe r of stages Buffer ph Mixed ph Binding Wash mm Na 2 HPO M NaCl Wash mm Na 2 HPO Elution 3 40 mm Citrate Strip 2 10 mm HCl M NaCl Equilibration 2 20 mm Na 2 HPO

22 Multiple Runs Run mab (g/l) mab Load Run Time Feed Flow Rate (L/hr) mab Load per Resin 1 feasibility g 3 hr g/l 2 long time g 24 hr g/l 3 high titer g 4 hr g/l

23 Run 1 - Pressure Profiles Pressure, P (psig) Stable operation Pressure <10 psi Laminar flow All plastic tubing and connectors Elapsed Time, t (hr)

24 Run 1- mab Purification Absorbance SEC Profiles Elution Pure mab CCCF >95% yield >98% purity Productivity of 63 g mab/l resin/hr (10x packed column) No detectable protein aggregates No detectable changes in resin Elution Time, t (min)

25 Run 1 - mab Purification Sample Host Cell Protein (ppm) Clarified Harvest 675,000 CCTC System 1,200 Packed Column 2,800 Host cell protein measured relative to mab via ELISA HCP level in CCTC system 2x lower than packed column Yield >95%, purity >98% Similar levels of high MW to purified (reference) mab

26 Run 2 Product Profile UV - Elution Steady-state with respect to product concentration and impurity profile Long time operation possible For t > 12 hr hollow fiber modules had to be replaced due to bacterial growth Time (hours)

27 Run 2 HCP levels HCP level remains constant throughout 24 hr run >95% purity Productivity of 19 g mab/l resin/hr (reduced due to low titer feed)

28 Run 3 - mab Purification Sample Host Cell Protein (ppm) 2 hr hr hr 382 HCP measured via ELISA relative to mab Very low HCP level due to use of high titer feed (4.5 g/l) spiked with purified mab >99% purity Productivity of 52 g mab/ L resin / hr 2.6 cycles / hr for resin

29 Advantages of CCTC System Continuous operation with high productivity All resin used at all times Steady-state operation with respect to product concentration and impurity profiles No columns / packing Reduced labor costs and validation Greater flexibility in multi-product facilities Disposable flow path if desired Potential for single-use systems Ideal for production of clinical batches

30 Future Opportunities Use of smaller resin particles Much better mass transfer less residence time needed in binding and elution steps Lower hold-up volume greater productivity No issues with pressure drop for slurry flow Direct integration with perfusion bioreactor Opportunity for continuous steady-state processing Dramatic improvements in overall productivity

31 Summary Countercurrent tangential chromatography (CCTC) for mab purification Continuous and steady-state operation demonstrated for 24 hr Purity and yield comparable to packed column Countercurrent staging reduces resin requirements while increasing product yield and purity Low pressure operation opportunities for disposable single-use flow path Modular design for enhanced flexibility

32 Acknowledgements Oleg Shinkazh Founder and President, Chromatan Boris Napadensky VP of Engineering, Chromatan Achyuta Teella Senior Scientist at Chromatan, Post-doc at Penn State Travis Tran Associate Scientist, Chromatan Gary Brookhart Senior Research Scientist, Fujifilm Diosynth

33 Funding / Support

Emerging and Enabling Technologies in Membrane Separations

Emerging 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 information

The monoclonal antibody (MAb) market

The 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 information

A novel approach to Protein A capture chromatography to help decrease cost of clinical manufacturing and reduce supply chain risk

A 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 information

A complete single-use manufacturing process of monoclonal antibodies: a case study

A complete single-use manufacturing process of monoclonal antibodies: a case study A complete single-use manufacturing process of monoclonal antibodies: a case study Jakob Liderfelt, Janne Simola, Annika Forss, Gustav Rodrigo, Karin Torstensson, Tomas Björkman, Kjell Eriksson, Hans J

More information

Next-generation, high-capacity, alkalistable

Next-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 information

GORE. Protein Capture Devices. Operating Instructions Contents. Product Description Device Characteristics... 2 General Handling...

GORE. 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 information

Phenyl Membrane Adsorber for Bioprocessing

Phenyl 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 information

3. Close the bottom end of the column and apply the packing device on top. Pump water through the upper adaptor to remove air.

3. 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 information

Capacity and performance of MabSelect PrismA protein A chromatography resin

Capacity 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 information

Evaluation of novel CEX resin for continous processing of MAb purification

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 information

WorkBeads Protein A INSTRUCTIONS IN

WorkBeads Protein A INSTRUCTIONS IN WorkBeads Protein A INSTRUCTIONS IN 40 605 010 WorkBeads Protein A resin is designed for the purification of monoclonal and polyclonal antibodies using affinity chromatography. For small scale purification

More information

Simplicity is the key Continuous purification of monoclonal antibodies

Simplicity 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 information

Bioprocessing 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. 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 information

Table 1, Performance characteristics of Cellufine SPA-HC

Table 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 information

Phenyl Membrane Adsorber for Bioprocessing

Phenyl 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 information

Tools and solutions for separation of charged mab variants

Tools 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 information

The 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 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 information

Continuous mab Purification Process: Design Features and Practical Considerations

Continuous 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 information

MabSelect SuRe pcc. Medium characteristics. GE Healthcare. Affinity chromatography. Optimized for continuous chromatography applications

MabSelect 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 information

Perfusion and Beyond The XCell TM ATF System

Perfusion 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 information

Emerging and Enabling Technologies in Chromatography of Integrated Biomanufacturing

Emerging and Enabling Technologies in Chromatography of Integrated Biomanufacturing Emerging and Enabling Technologies in Chromatography of Integrated Biomanufacturing Steven M. Cramer Isermann Department of Chemical and Biological Engineering Center for Biotechnology and Interdisciplinary

More information

INSTRUCTION IN

INSTRUCTION IN WorkBeads 40 Ni-NTA WorkBeads 40 Co-NTA WorkBeads 40 Cu-NTA WorkBeads 40 Zn-NTA INSTRUCTION IN 40 650 010 WorkBeads 40 Ni-IDA WorkBeads 40 Co-IDA WorkBeads 40 Cu-IDA WorkBeads 40 Zn-IDA These products

More information

Improving Bioprocessing Productivity Through the Application of Single-Use Protein A Columns

Improving Bioprocessing Productivity Through the Application of Single-Use Protein A Columns Improving Bioprocessing Productivity Through the Application of Single-Use Protein A Columns By K. John Morrow, Jr. Ph.D. In the last two decades, the bioprocessing industry has confronted the demands

More information

Periodic countercurrent (PCC)

Periodic 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 information

Implementing Continuous Chromatography into DSP of Bio-Molecules

Implementing 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 information

Polishing of monoclonal antibodies using Capto S ImpAct

Polishing 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 information

MabSelect SuRe. GE Healthcare. Alkali-stabilized protein A-derived medium for capture of monoclonal antibodies. High stability in alkaline conditions

MabSelect 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 information

1. Connect the column to the chromatography system, syringe or pump.

1. 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 information

ÄKTA pcc 75. General system description. GE Healthcare. Chromatography systems

ÄKTA 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 information

The Eshmuno Chromatography Family of Resins

The 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 information

Building 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 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 information

FastPure Spin Columns (Mini and Midi)

FastPure 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 information

Cadence Single-pass TFF Coupled with Chromatography Steps Enables Continuous Bioprocessing while Reducing Processing Times and Volumes

Cadence Single-pass TFF Coupled with Chromatography Steps Enables Continuous Bioprocessing while Reducing Processing Times and Volumes Application Note USD33 Cadence Single-pass TFF Coupled with Chromatography Steps Enables Continuous Bioprocessing while Reducing Processing Times and Volumes Catherine Casey 1, M.Sc., Karl Rogler 1, Xhorxhi

More information

Introduction 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 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 information

Adsorptive 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. 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 information

Application Note. Rapid optimisation and development of an automated two-step purification procedure for monoclonal IgG antibodies.

Application 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 information

The amazing ability of continuous chromatography to adapt to a moving environment.

The amazing ability of continuous chromatography to adapt to a moving environment. The amazing ability of continuous chromatography to adapt to a moving environment. Roger-Marc Nicoud, Founder of Novasep Barcelona, October 2013 Introduction My thesis: the environment pressure pushes

More information

Operational & Economic Evaluation of Integrated Continuous Biomanufacturing Strategies for Clinical & Commercial mab Production

Operational & 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 information

Downstream processing is a

Downstream 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 information

Polishing of monoclonal antibodies in bind/elute mode using Capto MMC ImpRes

Polishing of monoclonal antibodies in bind/elute mode using Capto MMC ImpRes Polishing of monoclonal antibodies in bind/elute mode using Capto MMC ImpRes Bengt Westerlund, Kristina Nilsson-Välimaa, Anders Ljunglöf, Peter Hagwall and Patrik Adielsson GE Healthcare Bio-Sciences AB,

More information

Sartobind IEX nano 3 ml

Sartobind 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 information

Efficient concentration of a low-titer bovine IgG with high recovery in low volume

Efficient 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 information

Downsizing downstream processing: A novel single-use purification platform for biologics

Downsizing 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 information

MabSelect Xtra. GE Healthcare. Recombinant protein A-based, high-capacity affinity medium. Medium characteristics Description

MabSelect Xtra. GE Healthcare. Recombinant protein A-based, high-capacity affinity medium. Medium characteristics Description GE Healthcare Data File 11-11-7 AB Affinity chromatography MabSelect Xtra Recombinant protein A-based, high-capacity affinity medium Many disorders that are treated with monoclonal antibodies, e.g. cancer

More information

Performance of the AbSolute High Cap resin in the Nimotuzumab capture step

Performance of the AbSolute High Cap resin in the Nimotuzumab capture step Research Article Journal of Biotechnology and Bioengineering Volume 1 Issue 1 Open Access Performance of the AbSolute High Cap resin in the Nimotuzumab capture step Martinez Rosario 1*, Ruland Yvan 2,

More information

BPI.Seminar Semina opelmg ropelmg.com com

BPI.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 information

CONTINUOUS MANUFACTURING FOR BIOLOGICS & VACCINES

CONTINUOUS 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 information

Purification strategies and platform alternatives for monoclonal antibodies

Purification strategies and platform alternatives for monoclonal antibodies Purification strategies and platform alternatives for monoclonal antibodies Annika Forss, Anna Grönberg, Anders Ljunglöf, Karin Torstenson GE Healthcare Life Sciences, Björkgatan 30, SE-751 84 Uppsala,

More information

Diffusional Contributions and Electrostatic Interactions during Ultrafiltration

Diffusional Contributions and Electrostatic Interactions during Ultrafiltration Diffusional Contributions and Electrostatic Interactions during Ultrafiltration Andrew L. Zydney Department Head and Walter L. Robb Family Chair Department of Chemical Engineering The Pennsylvania State

More information

MAbPurix TM Protein A Affinity Chromatography Resin media and column

MAbPurix TM Protein A Affinity Chromatography Resin media and column MAbPurix TM Protein A Affinity Chromatography Resin media and column Excellent Choice for Monoclonal Antibody Purification High Quality & Performance Significant Cost Saving Excellent technical support

More information

Driving Value through Innovation in Biotech Manufacturing. Agenda

Driving 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 information

Keeping ahead in biopharmaceutical manufacturing

Keeping 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 information

MabSelect PrismA. gelifesciences.com/bioprocess

MabSelect 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 information

GE Healthcare. Purification of monoclonal antibodies using modern chromatography media and membranes

GE Healthcare. Purification of monoclonal antibodies using modern chromatography media and membranes GE Healthcare Purification of monoclonal antibodies using modern chromatography media and membranes Purification of monoclonal antibodies using modern chromatography media and membranes The use of monoclonal

More information

Contichrom 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 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 information

BabyBio S BabyBio Q BabyBio DEAE

BabyBio S BabyBio Q BabyBio DEAE DATA SHEET BabyBio S BabyBio Q BabyBio DEAE BabyBio S, BabyBio Q and BabyBio DEAE are pre-packed, ready to use ion exchange columns for easy and convenient purification of proteins. Rapid method screening

More information

Mimetic 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 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 information

Glutathione Agarose Resin User s Guide

Glutathione Agarose Resin User s Guide Glutathione Agarose Resin User s Guide DESCRIPTION Glutathione Agarose Resin is used to purify recombinant derivatives of glutathione S-transferases or glutathione binding proteins. Resins are products

More information

HyperCel STAR AX Ion Exchange Sorbent

HyperCel 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 information

Next Generation Zirconia-Based Antibody Purification Media

Next Generation Zirconia-Based Antibody Purification Media Next Generation Zirconia-Based Antibody Purification Media Dr. Clayton McNeff, Dwight Stoll, Danielle Hawker (ZirChrom), Dr. Andy Clausen (Merck) Dr. Peter W. Carr and Dr. Anuradha Subramanian (U of MN)

More information

Phenyl Sepharose High Performance Butyl Sepharose High Performance

Phenyl 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 information

HyperCel STAR AX Ion Exchange Sorbent

HyperCel 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 information

Q and S HyperCel Sorbents

Q and S HyperCel Sorbents Product Note USD 9 () Q and S HyperCel Sorbents High Productivity Ion Exchangers for Protein Capture and Separations Product Description and Application Overview Introduction Q and S HyperCel sorbents

More information

Use of ScreenExpert RoboColumns u

Use of ScreenExpert RoboColumns u Application Note USD 99 Use of ScreenExpert RoboColumns u for High Throughput Study of Loading Conditions on HyperCel STAR AX and MEP HyperCel Sorbents for MAb Purification in Flow-Through Mode Summary

More information

Monoclonal antibodies

Monoclonal antibodies V E N D O R Voice A Strategy for Developing a Monoclonal Antibody Purification Platform Anna Grönberg, Elin Monié, Maria Murby, Gustav Rodrigo, Elisabeth Wallby, and Hans J. Johansson Monoclonal antibodies

More information

Column for High Performance,High-Binding Capacity Ion Exchange Chromatography:TSKgel SuperQ-5PW and Its Applications

Column 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 information

AFFINITY GST PURIFICATION

AFFINITY GST PURIFICATION DESCRIPTION Glutathione Agarose Resin is used to purify recombinant derivatives of glutathione S-transferases or glutathione binding proteins. are products that allow batch or column purifications. Purification

More information

ProteIndex Chemical-Tolerant Ni-Penta Agarose. Prepacked Cartridge. 6 FF Prepacked Cartridge, 5 x 1 ml settled resin

ProteIndex Chemical-Tolerant Ni-Penta Agarose. Prepacked Cartridge. 6 FF Prepacked Cartridge, 5 x 1 ml settled resin Store product at 2 C 8 C. Do not freeze. The product is shipped at ambient temperature. ProteIndex TM Chemical-Tolerant Ni-Penta Agarose 6 FF Prepacked Cartridge Cat. No. 11-0229-5x1ML 11-0229-1x5ML 11-0229-5x5ML

More information

BioPro SmartSep. Benefits of using BioPro SmartSep. Product information

BioPro SmartSep. Benefits of using BioPro SmartSep. Product information Product information IEX media are widely used in the analysis and purification of biomolecules. For instance, in industrial-scale protein production processes, IEX media are often used for initial product

More information

Future biologics manufacturing

Future 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 information

AFFINITY GST PURIFICATION

AFFINITY GST PURIFICATION DESCRIPTION Glutathione Agarose Resin is used to purify recombinant derivatives of glutathione S-transferases or glutathione binding proteins. are products that allow batch or column purifications. Purification

More information

MabSelect. GE Healthcare. Characteristics

MabSelect. GE Healthcare. Characteristics GE Healthcare Data File 18-1149-94 AE Affinity chromatography is a BioProcess affinity medium for capturing monoclonal antibodies from large volumes of feed by packed bed chromatography. offers the following

More information

The use of Chromatography Membranes for the development and production of biopharmaceuticals.

The 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 information

TOYOPEARL GigaCap Series

TOYOPEARL GigaCap Series TOYOPEARL GigaCap Series INTRODUCTION Ion Exchange Chromatography (IEC) is one of the most frequently used chromatographic modes for the separation and purification of biomolecules. Compared with other

More information

Kelly Thom Associate Principal Scientist Fujifilm Diosynth Biotechnologies. Your Biologics and Vaccines CDMO Partner of Choice.

Kelly 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 information

Separation of Monoclonal Antibodies Using TSKgel HPLC Columns

Separation 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 information

Application Note USD Purification of Mouse IgM from Cell Culture Supernatant by Cation Exchange Chromatography on CM Ceramic HyperD F Sorbent

Application Note USD Purification of Mouse IgM from Cell Culture Supernatant by Cation Exchange Chromatography on CM Ceramic HyperD F Sorbent Application Note USD 241 Purification of Mouse IgM from Cell Culture Supernatant by Cation Exchange Chromatography on CM Ceramic HyperD F Sorbent What this Study Demonstrates T h i s s t u d y o n C a

More information

Capture of human single-chain Fv (scfv) fusion protein on Capto L affinity medium

Capture 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 information

NatriFlo HD-Q Data File

NatriFlo 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 information

ProSep Ultra Plus Chromatography Media

ProSep Ultra Plus Chromatography Media Data Sheet Data Sheet ProSep Ultra Plus Chromatography Media The highest dynamic binding capacity protein A affinity chromatography media, designed for cost effective, large-scale purification of today

More information

Alkali Resistant and Optimized Ligand for High Capacity Surface Modified Base Bead for High Purity Semi-rigid Bead for High Productivity

Alkali Resistant and Optimized Ligand for High Capacity Surface Modified Base Bead for High Purity Semi-rigid Bead for High Productivity Alkali Resistant and Optimized Ligand for High Capacity Surface Modified Base Bead for High Purity Semi-rigid Bead for High Productivity True polymer innovation that bridges amorphous materials and agarose

More information

Alkali Resistant and Optimized Ligand for High Capacity Surface Modified Base Bead for High Purity Semi-rigid Bead for High Productivity

Alkali Resistant and Optimized Ligand for High Capacity Surface Modified Base Bead for High Purity Semi-rigid Bead for High Productivity Alkali Resistant and Optimized Ligand for High Capacity Surface Modified Base Bead for High Purity Semi-rigid Bead for High Productivity True polymer innovation that bridges amorphous materials and agarose

More information

Training Program 2019

Training 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 information

Single-use technology in downstream unit operations

Single-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 information

Cross Flow Filtration Method Handbook

Cross Flow Filtration Method Handbook Cross Flow Filtration Method Handbook Page intentionally left blank Table of Contents Table of Contents 1 Introduction... 1.1 What is cross flow filtration?... 1.2 Key features of CFF... 1.3 CFF application

More information

Operational & Economic Evaluation of Integrated Continuous Biomanufacturing Strategies for Clinical & Commercial mab Production

Operational & 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 information

Membrane Fouling at the Service of UF/MF: Hollow Fiber Membrane Adsorber

Membrane Fouling at the Service of UF/MF: Hollow Fiber Membrane Adsorber Membrane Fouling at the Service of UF/MF: Hollow Fiber Membrane Adsorber Yuriy Polyakov New Jersey Institute of Technology Newark, New Jersey E-mail: yuriypolyakov@lycos.com Membrane fouling in UF/MF is

More information

Productivity improvements in the capture and initial purification of monoclonal antibodies

Productivity improvements in the capture and initial purification of monoclonal antibodies Productivity improvements in the capture and initial purification of monoclonal antibodies Pete Gagnon, Validated Biosystems Inc. Richard Richieri, Avid Bioservices, Inc. 2 nd Wilbio Conference on Purification

More information

Protein-Pak Hi Res HIC Column and HIC Protein Standard

Protein-Pak Hi Res HIC Column and HIC Protein Standard Protein-Pak Hi Res HIC Column and HIC Protein Standard CONTENTS I. INTRODUCTION II. a. Mobile Phase b. Flow Direction CONNECTING COLUMN TO LC SYSTEM I. INTRODUCTION This offering contains non-porous, polymethacrylate-based

More information

Capture of mouse monoclonal antibodies

Capture 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 information

SMB-Chromatography. basic principle. Batch Chromatography. salad. True Moving Bed (TMB) salad. Chromatography Workshop 03/06 (Poland)

SMB-Chromatography. basic principle. Batch Chromatography. salad. True Moving Bed (TMB) salad. Chromatography Workshop 03/06 (Poland) SMB-Chromatography basic principle Batch Chromatography salad True Moving Bed (TMB) salad Merck KGaA Darmstadt/Germany Page 53 SMB-Chromatography basic principle extract (A) feed raffinate (B) fluid solid

More information

Cross-flow filtration for discovery, scale-up and process clarification/concentration applications

Cross-flow filtration for discovery, scale-up and process clarification/concentration applications biopharmaceutical / bioindustrial Cross-flow filtration for discovery, scale-up and process clarification/concentration applications lower binding and higher yields less fouling and longer service life

More information

Continuous Purity Technological, Regulatory and Validation Considerations for single-use continuous downstream processing

Continuous 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 information

Improving Downstream Manufacturing Productivity with Pre-Packed Chromatography Columns

Improving 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 information

MabSelect Xtra * GE Healthcare Life Sciences. Medium characteristics Description. MabSelect family

MabSelect Xtra * GE Healthcare Life Sciences. Medium characteristics Description. MabSelect family GE Healthcare Life Sciences Data file 11-11-7 AC Affinity chromatography MabSelect Xtra * MabSelect Xtra is a recombinant protein A-based affinity medium engineered to give an exceptionally high dynamic

More information

Purification of oligonucleotides by anion exchange chromatography

Purification of oligonucleotides by anion exchange chromatography Purification of oligonucleotides by anion exchange chromatography APPLICATION NOTE AN 4 1 1 AA Solid-phase synthesis of oligonucleotides generally give material of rather high purity. However, for many

More information

Buffer 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 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 information

YMC-BioPro NEW. porous and nonporous IEX columns. For the analysis and separation of peptides, proteins and biomolecules

YMC-BioPro NEW. porous and nonporous IEX columns. For the analysis and separation of peptides, proteins and biomolecules NEW porous and nonporous IEX columns For the analysis and separation of peptides, proteins and biomolecules QA / SP Pore size / nm: Particle size / μm: 5 Charged group: -CH N + (CH 3 ) 3 / -CH CH CH SO

More information

Using the Sartobind pico

Using the Sartobind pico Using the Sartobind pico Optimizing Steps for using micro-scale membrane adsorbers on liquid chromatography systems Application Note Steps for the successful use of Sartobind pico 1. Start with a new unused

More information

HiTrap NHS-activated HP

HiTrap NHS-activated HP GE Healthcare Life Sciences Instructions 71-7006-00 AW HiTrap affinity columns HiTrap NHS-activated HP 1 ml and 5 ml HiTrap NHS-activated HP is a prepacked ready to use, column for preparative affinity

More information