Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform

Size: px
Start display at page:

Download "Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform"

Transcription

1 Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform CHAPTER 1: Overview CHAPTER 2: Challenges CHAPTER 3: Purification Methodology CHAPTER 4: Results CHAPTER 5: About Eden Biodesign

2 Eden Biodesign has developed a purification methodology for the clinical production of an IgG4 monoclonal antibody. Learn more.

3 Chapter 1 Overview A soaring increase in the biopharmaceutical drug product pipeline due to more applied focus and identification of potential drug candidates has escalated the pressure within the biopharmaceutical industry to increase manufacturing capacity and to maximize potential from existing facilities. According to recent estimates, the global biopharmaceutical market is worth upwards of $75 Billion, with an expected growth rate of 12 percent per annum, with monoclonal antibodies accounting for a significant proportion of this market. Eden Biodesign has developed a purification methodology for the clinical production of monoclonal antibodies, with a view to the production of a robust and scalable platform antibody purification methodology. Read on to learn more about how Eden Biodesign is helping to overcome many of the technical obstacles and accelerate monoclonal antibody production with this platform approach.

4 Chapter 2 Challenges Historically, the major production bottleneck in monoclonal antibody production has been fermentation capacity. The industry has responded by producing ever higher yields using both new and novel expression systems, developing and optimizing new and existing growth media, and increasing cell densities. All have gone a long way towards increasing the productivity of the upstream fermentation processes, with the best examples of optimized monoclonal antibody fermentation achieving yields in the region in excess of 5 g/l. Theses advancements have meant that, over the past few years, an increasing emphasis has been placed on downstream purification processes, with low titre fermentations quickly becoming a thing of the past. Alongside the increase in yield, in process impurities have also increased, mainly due to more complex growth media and increased cell densities with lower cell viabilities. This introduces elevated levels of host cell proteins, lipids and nucleic acids into the process, offering a greater challenge to the purification process with harvest and clarification issues and column and chromatography resin limitations.

5 Chapter 3 Purification Methodology Monoclonal antibody production typically follows the following production processes: Step 1: Fermentation Step 2: Harvest & Clarification Step 3: Protein A Chromatography Step 4: Low ph Viral Inactivation Step 5: Cation Exchange Chromatography Step 6: Anion Exchange Chromatography Step 7: Concentration & Buffer Exchange Step 8: Viral Reduction Filtration Step 9: Bioburden Reduction

6 These steps can be complex and costly with the most significant limitation and cost being the Protein A Chromatography column. Eden Biodesign has developed a purification methodology for the clinical production of an IgG4 monoclonal antibody that offers several solutions to current antibody production challenges, including: High Throughput Processing Achieved with resins with high operational flow rates and increased dynamic binding capacities reducing batch time. Disposable Technology With the advantage of reducing cleaning validation requirements and plant turn-around times both of which offering significant cost benefits for a multi-product production facility.

7 Chapter 4 Results The objective was the development of an antibody purification process for the production of an IgG4 monoclonal antibody produced from a CHO cell line utilizing cell expression technology in a stirred tank bioreactor format using chemically defined growth media. Eden started with direct clarification of the bioreactor using Depth Filtration to remove gross cellular debris with fully disposable options. Eden then selected a panel of resins (Protein A, Cation and Anion Exchange) and performed a full resin screening followed by further process optimization of selected candidates. Once developed and optimized, Eden then applied the purification process at 2 L bioreactor scale, with a view to subsequent 20 L then 200 L verification batches. The purification process achieved was a robust, scalable process suitable for clinical manufacture with the ability to produce product of an extremely high degree of purity.

8 Analytical Results of this study include: ANALYSIS TECHNIQUE RESULT Endotoxin LAL <0.5 EU/mL DNA qpcr <16 pg/ml Purity (SEC) SEC 100% Host Cell Protein ELISA In Development Recovery ELISA In Development Because of the promising nature of these results, work is being conducted to further refine this antibody purification process.

9 Chapter 5 About Eden Biodesign As an established international biopharmaceutical development and manufacturing services provider, Eden Biodesign understands the required technical and regulatory issues involved in accelerating novel vaccine products into and through clinical development. Eden Biodesign offers the most scientifically advanced development and manufacturing services to biotech clients across Europe, the USA, Asia, Africa and Australia. We understand the challenges facing vaccine developers worldwide. We begin with the end in mind, helping you develop valuable biopharmaceutical medicines through the application of good science, right from day one.

10 Clients turn to Eden Biodesign for: Consultancy: Eden provides global CMC support, regulatory services, training, strategic insights and clinical logistics support. Process Design & Development: Eden specializes in helping our clients develop well defined, robust, scalable and reproducible processes, that are both commercially viable and regulatory compliant. cgmp Manufacturing Expertise: Eden offers cgmp manufacturing services for every significant biopharmaceutical production technology mammalian, microbial and viral. World Class Facilities: Our world-class facilities provide the full range of services required to take novel biopharmaceuticals and vaccines from proof of concept through to cgmp manufacturing for clinical trials.

11 Eden Biodesign Headquarters Eden Biodesign Ltd. NBC Estuary Banks Estuary Commerce Park Speke Road Liverpool, UK L24 8RB In the U.S. Eden Biodesign, Inc. Eden Biodesign, Inc Meridian Parkway Suite 300 Durham NC USA Visit Our Website

Monoclonal Antibody Production: Building the Platform. Andrew Clutterbuck Eden Biodesign Ltd.

Monoclonal Antibody Production: Building the Platform. Andrew Clutterbuck Eden Biodesign Ltd. Monoclonal Antibody Production: Building the Platform Andrew Clutterbuck Eden Biodesign Ltd. Questions Questions are encouraged throughout the presentation and can be asked by using the email address provided

More information

Accelerating drug development to FTIH: Potential of new expression technologies

Accelerating drug development to FTIH: Potential of new expression technologies Accelerating drug development to FTIH: Potential of new expression technologies Lekan Daramola Associate Director Biopharmaceutical Development, Cell Culture & Fermentation Sciences CMC Strategy Forum

More information

Advances in Biopharmaceutical and Vaccine Manufacturing Plants

Advances in Biopharmaceutical and Vaccine Manufacturing Plants Hitachi Review Vol. 62 (2013), No. 4 267 Advances in Biopharmaceutical and Vaccine Manufacturing Plants Sei Murakami, Dr. Eng. Haruo Suzuki Keisuke Shibuya, Dr. Sc. OVERVIEW: The development of innovative

More information

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission 1 2 3 25 April 2014 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided

More information

The Importance of Developing a High Yield of Product

The Importance of Developing a High Yield of Product European Antibody Congress Lyon, 3 rd November 2005 The Importance of Developing a High Yield of Product John Birch, Lonza Biologics plc Monoclonal Antibodies A Success Story Fastest growing segment of

More information

Valentina Gualato, Ph.D. Process Development Scientist

Valentina Gualato, Ph.D. Process Development Scientist COMPANY PRESENTATION Quality and Innovation Valentina Gualato, Ph.D. Process Development Scientist MISSION areta international is a biotech company dedicated to the contract development and manufacturing

More information

Multiple Products in a Monoclonal Antibody S88.01 Batch Plant

Multiple Products in a Monoclonal Antibody S88.01 Batch Plant Presented at the World Batch Forum North American Conference Chicago, IL May 16-19, 2004 900 Fox Valley Drive, Suite 204 Longwood, FL 32779-2552 +1.407.774.0207 Fax: +1.407.774.6751 E-mail: info@wbf.org

More information

Introduction to Bioprocessing

Introduction to Bioprocessing Introduction to Bioprocessing Cambridge Healthtech Institute Peptalk Palm Springs, CA Presented by Susan Dana Jones and Sheila Magil BioProcess Technology Consultants www.bptc.com BioProcess Technology

More information

Luca Romagnoli, Ph.D. Business Development Manager

Luca Romagnoli, Ph.D. Business Development Manager Modelli innovativi di produzione per lo sviluppo di un processo altamente qualitativo di farmaci biologici Luca Romagnoli, Ph.D. Business Development Manager BIOLOGICAL DRUGS - SOURCES Monoclonal antibodies

More information

Technology Transfer of CMC Activities for MAb Manufacturing. 2010 ge healthcare (www.gelifesciences.com)

Technology Transfer of CMC Activities for MAb Manufacturing. 2010 ge healthcare (www.gelifesciences.com) M a n u f a c t u r i n g OPERATIONS Technology Transfer of CMC Activities for MAb Manufacturing by Patricia Seymour, Susan Dana Jones, Howard L. Levine With combined 2009 revenues estimated to be over

More information

Process Performance Qualification. Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle

Process Performance Qualification. Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle Process Performance Qualification Demonstrating a High Degree of Assurance in Stage 2 of the Process Validation Lifecycle A LIFECYCLE Approach to Process Validation? Lifecycle [ICH Q8(R2)]: All phases

More information

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals MAbLaunch TM is a joint bioproduction platform combining LFB Biomanufacturing (LFB

More information

Biotechpharma company profile

Biotechpharma company profile Biotechpharma company profile October 2013 1 History 2004 Biotechpharma UAB established as a proteomic research company in Vilnius, Lithuania 2005 Company became a member of UK s Northway group, investing

More information

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission 28 April 2016 EMA/CHMP/BWP/187338/2014 Committee for Medicinal Products for Human Use (CHMP) Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be

More information

BIOTECH MANUFACTURING SOLUTIONS 4 YOUR SUCCESS. a Novartis company

BIOTECH MANUFACTURING SOLUTIONS 4 YOUR SUCCESS. a Novartis company a Novartis company BIOTECH MANUFACTURING Sandoz GmbH Biotech Cooperations 6250 Kundl Austria Biochemiestrasse10 Phone +43 (0)5338 200 2609 Fax +43 (0)5338 200 442 biotech.cooperations@sandoz.com www.sandoz.com

More information

From Research Services and Process Development to GMP Manufacturing

From Research Services and Process Development to GMP Manufacturing From Research Services and Process Development to GMP Manufacturing P a r ag o n B i o s e r v i c e s, I n c. A contract research and GMP manufacturing organization (CMO) with a focus on the development

More information

Protein Synthesis and Purification: Microbial Versus Mammalian Systems

Protein Synthesis and Purification: Microbial Versus Mammalian Systems STREAMLINING RECOMBINANT PROTEIN PRODUCTION The pharmaceutical industry is undergoing a deep transformation from small molecule drugs to biologics. Over the last decade, the percentage share of biologic-based

More information

Single Step Clarification & Capture of a Recombinant Protein from E. coli Osmotic Shock by Crossflow Chromatography

Single Step Clarification & Capture of a Recombinant Protein from E. coli Osmotic Shock by Crossflow Chromatography www.natrixseparations.com Complex Separations Single Step Clarification & Capture of a Recombinant Protein from E. coli Osmotic Shock by Crossflow Chromatography AN1000 Summary Recombinant Shiga toxin

More information

A World of Biomanufacturing: Shortages or Global Glut?

A World of Biomanufacturing: Shortages or Global Glut? A World of Biomanufacturing: Shortages or Global Glut? Howard L. Levine, Ph.D. BioProcess Technology Consultants, Inc. BioProcess International Conference Vienna, Austria May 19-20, 2010 Steady growth

More information

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals MAbLaunch TM is a joint bioproduction platform combining LFB Biomanufacturing (LFB

More information

Challenges in the cgmp Manufacturing of hescs: Lessons Learned from Monoclonal Antibodies

Challenges in the cgmp Manufacturing of hescs: Lessons Learned from Monoclonal Antibodies Challenges in the cgmp Manufacturing of hescs: Lessons Learned from Monoclonal Antibodies ISCT 2011 Annual Meeting Rotterdam, The Netherlands May 18 21, 2011 BioProcess Technology Consultants www.bptc.com

More information

A new, integrated, continuous purification process template for monoclonal antibodies

A new, integrated, continuous purification process template for monoclonal antibodies A new, integrated, continuous purification process template for monoclonal antibodies Alex Xenopoulos* Alison Dupont, Christopher Gillespie, Ajish Potty, Michael Phillips Processing Technologies Merck

More information

Mab manufacturing today and tomorrow. Reducing risk, reducing cost. Reducing costs, informing decisions, insight for innovation.

Mab manufacturing today and tomorrow. Reducing risk, reducing cost. Reducing costs, informing decisions, insight for innovation. Mab manufacturing today and tomorrow. Reducing risk, reducing cost. Reducing costs, informing decisions, insight for innovation. Summary Monoclonal antibodies are expensive to develop and to manufacture.

More information

Customer Application Brief. Filtration Processes Applied in Therapeutic Monoclonal Antibody Production. Bioprocess, Biologicals, & Pharmaceutical

Customer Application Brief. Filtration Processes Applied in Therapeutic Monoclonal Antibody Production. Bioprocess, Biologicals, & Pharmaceutical Customer Application Brief Bioprocess, Biologicals, & Pharmaceutical Filtration Processes Applied in Therapeutic Monoclonal Antibody Production Introduction Monoclonal antibodies were among the first biotechnology

More information

Biopharmaceutical Process Evaluated for Viral Clearance

Biopharmaceutical Process Evaluated for Viral Clearance Authored by S. Steve Zhou, Ph.D. Microbac Laboratories, Inc., Microbiotest Division The purpose of Viral Clearance evaluation is to assess the capability of a manufacturing production process to inactivate

More information

Use of the ambr 250 in combination with high-throughput design and analysis tools for rapid, scalable USP development

Use of the ambr 250 in combination with high-throughput design and analysis tools for rapid, scalable USP development Use of the ambr 250 in combination with high-throughput design and analysis tools for rapid, scalable USP development Authors: Dr Fern Slingsby and Dr Simon Dewar Upstream Process Development FUJIFILM

More information

Cell Line: HD-BIOP3 Suspension adapted GS null CHO K1 cells

Cell Line: HD-BIOP3 Suspension adapted GS null CHO K1 cells Cell Line Data Pack Cell Line: HD-BIOP3 Suspension adapted GS null CHO K1 cells t + 44 ()1223 65558 f + 44 ()1223 655581 e info@horizondiscovery.com w www.horizondiscovery.com Horizon Discovery, 71 Cambridge

More information

The market for therapeutic monoclonal antibodies

The market for therapeutic monoclonal antibodies PURIFYING THERAPEUTIC MONOCLONAL ANTIBODIES Amit Mehta, Martha Lovato Tse, Jace Fogle, Amy Len, Roshan Shrestha, Nuno Fontes, Bénédicte Lebreton, Bradley Wolk, Robert van Reis Genentech Eliminating the

More information

Gain efficiency in your process development with ÄKTA avant

Gain efficiency in your process development with ÄKTA avant Gain efficiency in your process development with ÄKTA avant gelifesciences.com Gain efficiency in your process development with ÄKTA avant Development of efficient manufacturing processes is a necessity

More information

Process-scale purification of monoclonal antibodies polishing using Capto Q

Process-scale purification of monoclonal antibodies polishing using Capto Q GE Healthcare Life Sciences Application note 28-937-16 AB Ion exchange chromatography Process-scale purification of monoclonal antibodies polishing using Capto Q Summary Anionic exchange media are an industry

More information

Guidance for Industry. Monoclonal Antibodies Used as Reagents in Drug Manufacturing

Guidance for Industry. Monoclonal Antibodies Used as Reagents in Drug Manufacturing Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing U.S. Department of Health and Human Services Food and Drug Administration enter for Drug Evaluation and Research (DER)

More information

Exciting Trends in Bioprocessing

Exciting Trends in Bioprocessing Exciting Trends in Bioprocessing Alfred Doig and Susan Dana Jones, Ph.D. April 20, 2015 BioProcess Technology Consultants, Inc. 12 Gill Street, Suite 5450 Woburn, MA 01801 Exciting Trends in Bioprocessing

More information

Filtration in Preparation of Cell Culture Media and Buffers

Filtration in Preparation of Cell Culture Media and Buffers pplication Guide Filtration in Preparation of Cell Culture Media and Buffers Cell Culture Media and Buffers in Biopharmaceutical Production Cell culture media and process buffers are used in all biopharmaceutical

More information

Transgenic technology in the production of therapeutic proteins

Transgenic technology in the production of therapeutic proteins Transgenic technology in the production of therapeutic proteins Transgenic technology represents a new generation of biopharmaceutical production system to meet the medical needs of the new millennium.

More information

Manufacturing process of biologics

Manufacturing process of biologics Manufacturing process of biologics K. Ho Afssaps, France 2011 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2011 ICH 1 Disclaimer:

More information

Facility construction and start up for commercial scale manufacturing of monoclonal antibodies - A case study

Facility construction and start up for commercial scale manufacturing of monoclonal antibodies - A case study 24 th Interphex, Japan, Technical Conference June 29 th, 2011 Michael Brown Facility construction and start up for commercial scale manufacturing of monoclonal antibodies - A case study Lonza AG Financially

More information

Lonza Custom Manufacturing

Lonza Custom Manufacturing Lonza Custom Manufacturing Overview Lonza established the concept of custom manufacturing over 25 years ago, recognizing the trend toward outsourcing in the pharmaceutical industry. Since then, Lonza Custom

More information

Bioprocessing Media and Buffers Grow with Us

Bioprocessing Media and Buffers Grow with Us Bioprocessing Media and Buffers Grow with Us Experience Highly experienced media on the selection of standard media as well as development This service packaging, documentation Leading position in single-use

More information

Biomanufacturing Vision for the Future

Biomanufacturing Vision for the Future Biomanufacturing Vision for the Future Shou-Bai Chao, Ph.D. Senior Vice President Global Manufacturing and Technical Operations MedImmune (a Div of AstraZeneca) NIPTE/FDA Research Conference Future of

More information

Economical Approaches to Meeting Global Demand for High Value Biopharmaceuticals

Economical Approaches to Meeting Global Demand for High Value Biopharmaceuticals Economical Approaches to Meeting Global Demand for High Value Biopharmaceuticals Howard L. Levine and Susan Dana Jones BPI Europe 2013 Apr 17-18, 2013 Dusseldorf, Germany BioProcess Technology Consultants

More information

High-speed quantitation or purification

High-speed quantitation or purification PRODUCT BULLETIN POROS Affinity Chromatography Columns POROS Affinity Chromatography Columns High-speed quantitation or purification Broad utility POROS A, G, and CaptureSelect affinity ligands address

More information

Zeta Plus. Encapsulated Filter System Innovative Filtration. Fast, easy and clean. Lenntech. 3M Puriication

Zeta Plus. Encapsulated Filter System Innovative Filtration. Fast, easy and clean. Lenntech. 3M Puriication 3M Puriication Single-Use Depth Filtration Product Brochure Lenntech info@lenntech.com Tel. +31-152-610-900 www.lenntech.com Fax. +31-152-616-289 Encapsulated Filter System Innovative Filtration. Fast,

More information

THE DEVELOPMENT OF THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS

THE DEVELOPMENT OF THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS THE DEVELOPMENT OF THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS Table of Contents CHAPTER 1: Overview of Monoclonal Antibody Therapeutics CHAPTER 2: Monoclonal Antibody Discovery Technologies CHAPTER 3: CMC

More information

Una nueva plataforma para la producción de vectores lentivirales para preclínica y bajo cgmp

Una nueva plataforma para la producción de vectores lentivirales para preclínica y bajo cgmp Una nueva plataforma para la producción de vectores lentivirales para preclínica y bajo cgmp XLVIII LECCIÓN CONMEMORATIVA JIMÉNEZ DÍAZ Madrid Mayo 2016 Juan C Ramírez CSO/CTO Non-Disclosure/Confidentiality

More information

Vaccine Manufacturing Facilities of the Future. Howard L. Levine, Ph.D. Vaccines Europe London, England December 1 2, 2010

Vaccine Manufacturing Facilities of the Future. Howard L. Levine, Ph.D. Vaccines Europe London, England December 1 2, 2010 Vaccine Manufacturing Facilities of the Future Howard L. Levine, Ph.D. Vaccines Europe London, England December 1 2, 2010 Challenges in the Production of Vaccines Different technology platforms make it

More information

Triskel: a strategic consulting firm for biopharmaceutical companies

Triskel: a strategic consulting firm for biopharmaceutical companies BioStart : Manufacturing and operations in Biotech Strategic stakes and technology evolution in recombinant protein production APFL May 14 th, 2009 François LAWNY Triskel Integrated Services Geneva, Switzerland

More information

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to C 5 chemical development contract research custom synthesis cgmp API manufacturing commercial production Welcome to ChemCon Company profile Company profile ChemCon offers outstanding chemical services

More information

Optimization of Cell Culture Processes for the Production of Therapeutic Monoclonal Antibodies. John Birch

Optimization of Cell Culture Processes for the Production of Therapeutic Monoclonal Antibodies. John Birch Optimization of Cell Culture Processes for the Production of Therapeutic Monoclonal Antibodies John Birch Facilities U.K. R &D + small scale manufacture 200 litre airlift reactors 2000 litre airlift reactors

More information

Application Note. Purifying common light-chain bispecific antibodies using MCSGP. Summary

Application Note. Purifying common light-chain bispecific antibodies using MCSGP. Summary Application Note Purifying common light-chain bispecific antibodies using MCSGP Category Matrix Method Keywords Analytes ID Continuous chromatography, biochromatography Antibodies MCSGP Bispecific antibody,

More information

PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY

PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY Guideline Title Production and Quality Control of Medicinal Products derived by recombinant DNA Technology Legislative

More information

Separatome of Escherichia Coli Analysis of DEAE Chromatography as ph of loading changes

Separatome of Escherichia Coli Analysis of DEAE Chromatography as ph of loading changes University of Arkansas, Fayetteville ScholarWorks@UARK Chemical Engineering Undergraduate Honors Theses Chemical Engineering 5-2015 Separatome of Escherichia Coli Analysis of DEAE Chromatography as ph

More information

During regulatory inspections,

During regulatory inspections, B I O P R O C E S S TECHNICAL Cleaning and Cleaning Validation in Process Chromatography Current Industry Practices and Future Prospects Gail Sofer and Jonathan Yourkin During regulatory inspections, manufacturers

More information

Workshop on process validation

Workshop on process validation Workshop on process validation CMC Strategy Forum Europe 2013 EBE Process validation satellite session Pragues, 06/05/2013 Kowid Ho Scope / background Process evaluation/validation of biotechnology derived

More information

Evaluation of an alkali stable Protein A matrix versus Protein A Sepharose Fast Flow and considerations on process scale-up to 20,000L.

Evaluation of an alkali stable Protein A matrix versus Protein A Sepharose Fast Flow and considerations on process scale-up to 20,000L. Evaluation of an alkali stable Protein A matrix versus Protein A Sepharose Fast Flow and considerations on process scale-up to 20,000L. Simon C.B. Jones & Martin P. Smith. LONZA, 224 Bath Road, Slough,

More information

Pharmaceuticals Production Services Boehringer Ingelheim. Our expertise in world-class contract manufacturing for your success

Pharmaceuticals Production Services Boehringer Ingelheim. Our expertise in world-class contract manufacturing for your success Pharmaceuticals Production Services Boehringer Ingelheim Our expertise in world-class contract manufacturing for your success Successful partnership Dr Wolfram Carius Head of Corporate Division Pharmaceuticals

More information

Bringing Downstream Productivity into Phase with Upstream Antibody Production

Bringing Downstream Productivity into Phase with Upstream Antibody Production Bringing Downstream Productivity into Phase with Upstream Antibody Production Pete Gagnon, Validated Biosystems 3 rd International Monolith Symposium, Portoroz, May 30 June 4, 2008 The need for speed When

More information

NEW CHEMICAL ENTITIES

NEW CHEMICAL ENTITIES NEW CHEMICAL ENTITIES PIONEERING PARTNER FOR PEPTIDES With more than 40 years of expertise in peptide synthesis, a track record in process development, large-scale manufacturing and outstanding product

More information

exactly. The need for efficiency in developing effective new therapeutics has never been greater.

exactly. The need for efficiency in developing effective new therapeutics has never been greater. exactly. The need for efficiency in developing effective new therapeutics has never been greater. As demands on the global healthcare system increase and treating disease becomes more complex, the research,

More information

Highly Potent APIs The right platform, people and procedures for successful development and manufacturing

Highly Potent APIs The right platform, people and procedures for successful development and manufacturing Pharma&Biotech Highly Potent APIs The right platform, people and procedures for successful development and manufacturing Custom Manufacturing and Development Services for Highly Potent APIs Pharma&Biotech

More information

Manufacturing processes for

Manufacturing processes for Single-Use, Continuous- Countercurrent, Multicolumn Chromatography Marc Bisschops, Lynne Frick, Scott Fulton, and Tom Ransohoff Reprinted with permission from BioProcess International 7(6) (June 2009)

More information

Mammalian Cell Culture: Current Status, Future Prospects

Mammalian Cell Culture: Current Status, Future Prospects Cell Culture and Upstream Processing, Berlin, September 2004 Mammalian Cell Culture: Current Status, Future Prospects John Birch Lonza Cell Culture: an Industrial Process Much of the early process development

More information

Application Note. Separation of three monoclonal antibody variants using MCSGP. Summary

Application Note. Separation of three monoclonal antibody variants using MCSGP. Summary Application Note Separation of three monoclonal antibody variants using MCSGP Category Matrix Method Keywords Analytes ID Continuous chromatography, Biochromatography; FPLC Protein A-purified monoclonal

More information

Providing Trusted and Innovative Solutions t o the Life Science Communities

Providing Trusted and Innovative Solutions t o the Life Science Communities Providing Trusted and Innovative Solutions t o the Life Science Communities Eurogentec Eurogentec is a leading supplier of trusted and innovative reagents, kits, specialty products and custom research/development

More information

Risk analysis and management is the cornerstone

Risk analysis and management is the cornerstone Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE This article presents a new type of risk tool. Risk Analysis and Mitigation Matrix (RAMM) was developed to be incorporated into a

More information

Viral Safety of Plasma-Derived Products

Viral Safety of Plasma-Derived Products Viral Safety of Plasma-Derived Products SLIDE 1 This presentation will cover viral validation studies for plasma-derived products. FDA requires that the manufacturing process for biopharmaceutical products

More information

Testing Services for Large Molecule Drug Development

Testing Services for Large Molecule Drug Development Testing Services for Large Molecule Drug Development Our mission is to extend our clients capabilities by combining scientific knowledge, capacity, regulatory expertise and flexibility to provide the trusted,

More information

GE Healthcare Life Sciences. An environmental life cycle assessment comparison of single-use and conventional bioprocessing technology

GE Healthcare Life Sciences. An environmental life cycle assessment comparison of single-use and conventional bioprocessing technology GE Healthcare Life Sciences An environmental life cycle assessment comparison of single-use and conventional bioprocessing technology An environmental life cycle assessment comparison of single-use and

More information

MOUNT WACHUSETT COMMUNITY COLLEGE DEVENS, MASSACHUSETTS. COURSE SYLLABUS Fall Semester 2010

MOUNT WACHUSETT COMMUNITY COLLEGE DEVENS, MASSACHUSETTS. COURSE SYLLABUS Fall Semester 2010 MOUNT WACHUSETT COMMUNITY COLLEGE DEVENS, MASSACHUSETTS COURSE SYLLABUS Fall Semester 2010 COURSE: TEXT: BTC120 Biotechnology Experience II: Biomanufacturing (4 credits) Industrial Biotechnology: A Training

More information

Company Presentation

Company Presentation Company Presentation DISCLAIMER This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and asset situation of amp biosimilars

More information

Data Mining Builds Process Understanding for Vaccine Manufacturing

Data Mining Builds Process Understanding for Vaccine Manufacturing Data Mining Builds Process Understanding for Vaccine Manufacturing WCBP 2009 Current Topics in Vaccine Development January 14, 2009 Julia O Neill, Principal Engineer Merck & Co., Inc. Global Vaccine Technology

More information

High yield antibody production in a disposable WAVE Bioreactor

High yield antibody production in a disposable WAVE Bioreactor High yield antibody production in a Process intensification using perfusion culture Christian Kaisermayer 1, Jianjun Yang 2 1 GE Healthcare Europe GmbH, Vienna, Austria (Christian.Kaisermayer@ge.com),

More information

CHMP/BWP DRAFT GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS

CHMP/BWP DRAFT GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS European Medicines Agency Evaluation of Medicines for Human Use London, 28 June 2006 Doc. Ref. EMEA/CHMP/BWP/398498/2005-corr CHMP/BWP DRAFT GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL

More information

PlantForm Corporation

PlantForm Corporation PlantForm Corporation Professor J. Christopher Hall CSO PlantForm Corporation Canada s Top10 Winner Life Sciences 2008/9 Innovator of the Year Guelph, Canada, 2010 Opportunity The introduction of more

More information

KMS-Specialist & Customized Biosimilar Service

KMS-Specialist & Customized Biosimilar Service KMS-Specialist & Customized Biosimilar Service 1. Polyclonal Antibody Development Service KMS offering a variety of Polyclonal Antibody Services to fit your research and production needs. we develop polyclonal

More information

Table of Contents. Presented by

Table of Contents. Presented by Improving Markets, Services, and Technologies Table of Contents Presented by HighTech Business Decisions 3150 Almaden Expressway, Suite 222, San Jose, CA 95118 Tel: (408) 978-1035 Fax: (408) 978-8925 www.hightechdecisions.com

More information

Advanced BioDesign Outlines Solutions. Antibody Overview. by Advanced BioDesign. Project Start. Immunogenicity. Selecting Your Antigen

Advanced BioDesign Outlines Solutions. Antibody Overview. by Advanced BioDesign. Project Start. Immunogenicity. Selecting Your Antigen Advanced BioDesign Outlines Solutions by Advanced BioDesign Antibody Overview Launching an immunisation programme is an important experimental step that needs care. With Advanced BioDesign, you may develop

More information

USD 2195a. Pall Mustang Chromatography Capsules. For High Throughput Disposable Ion Exchange Chromatography

USD 2195a. Pall Mustang Chromatography Capsules. For High Throughput Disposable Ion Exchange Chromatography USD 2195a Pall Mustang Chromatography Capsules For High Throughput Disposable Ion Exchange Chromatography High Throughput Disposable Membrane Chromatography Products Ion exchange column chromatography

More information

Drive Process Productivity

Drive Process Productivity Solutions for the Biopharmaceutical Industry Drive Process Productivity Innovative solutions from a proven technology leader Your partner in productivity Whether you are developing a process for a novel

More information

Integrated Protein Services

Integrated Protein Services Integrated Protein Services Custom protein expression & purification Last date of revision June 2015 Version DC04-0013 www.iba-lifesciences.com Expression strategy The first step in the recombinant protein

More information

Catalent Biologics & Clinical Supplies The SMART Solution

Catalent Biologics & Clinical Supplies The SMART Solution Catalent Biologics & Clinical Supplies The SMART Solution Advanced Technology and Integrated Solutions From DNA to Clinical Supply & Cold Chain Distribution Dr. Florian Schwaak Account Manager Germany

More information

A novel AIEX chromatography medium (resin) to remove IgA and IVIG purification process

A novel AIEX chromatography medium (resin) to remove IgA and IVIG purification process A novel AIEX chromatography medium (resin) to remove IgA and IVIG purification Guodong Javier Jia 1, Chor Sing Tan 2, Linus Laurin 3, Henrik Ihre 3, Lili Sui 1 1 Fast Trak China, GE Healthcare Life Sciences,

More information

Dr.ssa Maria Luisa Nolli CEO

Dr.ssa Maria Luisa Nolli CEO IL RUOLO DELLE PICCOLE E MEDIE INDUSTRIE NELLA PROMOZIONE DELLA MEDICINA TRASLAZIONALE Quality and Innovation Dr.ssa Maria Luisa Nolli CEO INTRODUCTION ARETA INTERNATIONAL 12 years of experience in contract

More information

Genes to Proteins to Antibodies

Genes to Proteins to Antibodies Genes to Proteins to Antibodies About Us Fusion Antibodies is a CRO established in 2001 as a spin-out from Queen s University Belfast. The company building is situated in a charming area of Springbank

More information

PX Therapeutics : the partner for early stage biotherapeutics development Biotuesday, May 5 2009

PX Therapeutics : the partner for early stage biotherapeutics development Biotuesday, May 5 2009 PX Therapeutics : the partner for early stage biotherapeutics development Biotuesday, May 5 2009 Christelle Dagoneau, PhD Business Development Director Company Profile Protein expert incorporated in 2000

More information

Advances in The Development of Biopharmaceuticals

Advances in The Development of Biopharmaceuticals Advances in The Development of Biopharmaceuticals The application of modern technologies and services to the development of Biopharmaceutical processes Dr Jonathan H Dempsey Process Science Fellow Invitrogen

More information

One of the greatest challenges facing biopharmaceutical

One of the greatest challenges facing biopharmaceutical Monoclonal Antibody Manufacturing Strategies for the 21st Century James Blackwell, Ph.D., MBA Sr. Consultant Thomas Ransohoff, VP and Sr. Consultant Howard L. Levine, Ph.D., President and Principal Consultant

More information

Copyright is owned by the Author of the thesis. Permission is given for a copy to be downloaded by an individual for the purpose of research and

Copyright is owned by the Author of the thesis. Permission is given for a copy to be downloaded by an individual for the purpose of research and Copyright is owned by the Author of the thesis. Permission is given for a copy to be downloaded by an individual for the purpose of research and private study only. The thesis may not be reproduced elsewhere

More information

Single-Use Bioreactors Meeting BioPharma Needs for Lower Operating Cost and Faster Time to Market

Single-Use Bioreactors Meeting BioPharma Needs for Lower Operating Cost and Faster Time to Market Single-Use Bioreactors Meeting BioPharma Needs for Lower Operating Cost and Faster Time to Market White Paper White Paper Single-use bioreactors meeting biopharma needs for lower operating cost and faster

More information

3 Chapter Three: Material and methods (clone creation, upstream and downstream process)

3 Chapter Three: Material and methods (clone creation, upstream and downstream process) 3 Chapter Three: Material and methods (clone creation, upstream and downstream process) 3.1 Model proteins and CHO cell cultures Two recombinant produced, CHO-cell-derived model-glycoproteins, a less glycosylated

More information

A Risk Assessment of Pre-Licensure Manufacturing Changes

A Risk Assessment of Pre-Licensure Manufacturing Changes A Risk Assessment of Pre-Licensure Manufacturing Changes Patrick G. Swann, Ph.D. Deputy Director Division of Monoclonal Antibodies Office of Biotechnology Products Office of Pharmaceutical Science FDA-CDER

More information

NUVISAN Pharma Services

NUVISAN Pharma Services NUVISAN Pharma Services CESI MS Now available! 1st CRO in Europe! At the highest levels of quality. LABORATORY SERVICES Equipment update STATE OF THE ART AT NUVISAN CESI MS Now available! 1st CRO in Europe!

More information

Integrated Protein Services

Integrated Protein Services Integrated Protein Services Custom protein expression & purification Version DC04-0012 Expression strategy The first step in the recombinant protein generation process is to design an appropriate expression

More information

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH VWR enables the advancement of science by providing high-quality chemicals and services, customized to your

More information

TESTIMONIAL: Congratulations! Our company s EID Incoming Inspection of AMRESCO-provided products

TESTIMONIAL: Congratulations! Our company s EID Incoming Inspection of AMRESCO-provided products custom solutions With markets changing so rapidly, AMRESCO is on the front line bringing new technologies and processes so we can deliver solutions that solve our customers problems. TESTIMONIAL: Congratulations!

More information

Technologies for Monoclonal Antibody Production

Technologies for Monoclonal Antibody Production Technologies for Monoclonal Antibody Production First we help you bridge the distance between upstream and downstream. Then we help you shorten it. Monoclonal antibodies for therapeutic, diagnostic and

More information

Next-Generation Facilities for Monoclonal Antibody Production

Next-Generation Facilities for Monoclonal Antibody Production Advancing Development & Manufacturing Facilities Next-Generation Facilities for Monoclonal Antibody Production Niels Guldager ELECTRONICALLY REPRINTED FROM JULY 2009 The biopharmaceutical industry faces

More information

Accelerated Stability During Formulation Development of Early Stage Protein Therapeutics Pros and Cons of Contrasting Approaches

Accelerated Stability During Formulation Development of Early Stage Protein Therapeutics Pros and Cons of Contrasting Approaches Accelerated Stability During Formulation Development of Early Stage Protein Therapeutics Pros and Cons of Contrasting Approaches 2008 IBC Formulation Strategies for Protein Therapeutics Tim Kelly, Ph.D.

More information

BIOTECHNOLOGY OPERATIONS

BIOTECHNOLOGY OPERATIONS BIOTECHNOLOGY OPERATIONS Principles and Practices Michael J. Roy TECHNISCHE INFORMATION SBIBLIOTHEK UNIVERSITATSBIBLIOTHEK HANNOVER CRC Press TaylorStFrancis Croup Boca Raton London New York CRC Press

More information

SCANTIBODIES Laboratory, Inc. Contract Monoclonal Antibody Production

SCANTIBODIES Laboratory, Inc. Contract Monoclonal Antibody Production A Technical Publication of SCANTIBODIES Laboratory, Inc. Volume 1 Number 4 9336 Abraham Way Santee, CA 92071 USA (619) 258-9300 fax (619) 258-9366 www.scantibodies.com SCANTIBODIES Laboratory, Inc. Contract

More information

Overview of Upstream and Downstream Processing of Biopharmaceuticals

Overview of Upstream and Downstream Processing of Biopharmaceuticals Overview of Upstream and Downstream Processing of Biopharmaceuticals Ian Marison Professor of Bioprocess Engineering and Head of School of Biotechnology, Dublin City University, Glasnevin, Dublin 9, Ireland

More information