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

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

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

Transcription

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

2 MAbLaunch TM is a joint bioproduction platform combining LFB Biomanufacturing (LFB Group) and BioLaunch (Sanofi) capabilities in the field of contract and manufacturing services. The platform is supported by a collaboration agreement between Sanofi* and the LFB Group** to capitalize on the use of their respective industrial capacities and to provide the widest range of CMO services to customers in the most flexible manner. MAbLaunch TM has developed considerable expertise in process and manufacturing of monoclonal antibodies and recombinant proteins using mammalian cell technology. The MAbLaunch TM offer starts with cell line, going through process and scale up and continuing into manufacturing of clinical and commercial batches. *through its subsidiary Sanofi Chimie **through its subsidiary LFB Biotechnologies Pilot facilities: Process, pilot production and scale-up Bioengineering laboratory Mammalian cell line platforms ( CHO and YB2/0 - EMABling ) Quality Control laboratory Roller bottle systems Spinners 25L Wave system 40L stainless steel bioreactor 50L & 200L disposable bioreactors Chromatography systems Virus inactivation and nanofiltration Filtration, ultrafiltration Analytical systems GMP production facilities: USP: 6 independent bioproduction lines with the following bioreactor capacities: > 1x 300L (stainless steel bioreactor) > 1x 1,000L (disposable bioreactor) > 1x 2,000L (disposable bioreactor; available soon > 3x 10,000L (stainless steel bioreactors) Industrial chromatography systems Ultrafiltration/Diafiltration systems Viral inactivation/nanofiltration Fill and finish facilities: > Pre-filled syringes from 0.5mL to 20mL > Cartridges from 1.7mL to 3.2mL > Vials from 2mL to 150mL > Lyophilized vials from 2mL to 20mL > Dosing system: time/pressure or peristaltic pump Inspection: automated or semi-automated

3 Contract Biomanufac Service Discovery Pre-clinical Clinical Registration Commercialization Expression vector construction MAb chimerization and humanization Cell line Vector transfection and transient expression Stable cell line generation and clone selection EMABling technology (see details on the right page ) Cell banking Project management Quality assurance Regulatory support Process and scale-up Cell culture Process - Media optimization, yield improvement Downstream Process Viral clearance validation Manufacturing of non-gmp batches up to 200L Analytical stability studies - QC testing GMP master and working cell bank production Manufacturing of GMP batches at 300L and 1,000L scale Manufacturing of clinical and commercial batches Manufacturing of GMP batches at 10,000L scale Galenic form Fill and finish vials, pre-filled syringes, freeze-dried vials, cartridges Stability studies Clinical packing

4 turing Services offer Cell line MAbLaunch TM is able to offer bioproduction services using the client s own cell line, or through a specific cell line program, to express the client s recombinant protein, using proprietary or non-proprietary cell expression systems. The different steps may include molecular and cellular engineering to create a chimeric or humanized monoclonal antibody by vector construction, gene transfection and cell line in order to establish a stable cell line. NEW! EMABling technology EMABling is a technology developed by the LFB Group to produce highy active recombinant monoclonal antibodies using the YB2/0 cell line. These antibodies display an enhanced antibody-dependent cellular cytotoxicity (ADCC) activity due to an improved glycosylation profile. LFB s research in this area has been based on the study of structure-function relationships for monoclonal antibodies and critical impact of post-translational modifications to their functional activity (role of glycans). Combined with specifically optimized expression vectors / CD medium and a powerful CLD process (including the use ClonePix-FL cloning robot), the EMABling platform leads to gram-per-liter producing clones. Customers now can access to the EMABling platform to produce their own recombinant high-adcc mabs. Process Development and scale-up Process and scale-up are essential to obtain a competitive commercial product. To tackle this important issue, MAbLaunch TM s services cover adaptation of cell culture to serum-free media and/or media optimization for yield improvement. Upstream and downstream process optimizations are executed in state-of-the-art facilities. MAbLaunch TM s technological options include static or stirred vessels, hollow-fiber bioreactors or disposable bioreactors. Our in-house scientists and our network of experts will facilitate the of optimum cell culture conditions for each cell line. Our engineering staff have vast experience and the technical knowledge necessary to select the best chromatography and filtration systems, most appropriate buffers to establish optimal purification processes and viral clearance methods. MAbLaunch TM has a proven track record in tackling a number of challenging processes and scale-up, resulting in successful production of many antibodies and recombinant proteins. Manufacturing of clinical and commercial batches With its versatile range of production technologies, MAbLaunch TM can undertake GMP cell banking and production of biopharmaceuticals for Phase I to Phase III clinical trials and small to large-scale commercial supplies to meet the specific needs of our customers. In conjunction with these drug substance manufacturing capabilities, MAbLaunch TM (via the international network of Sanofi facilities) is able to offer access to significant fill & finish capacities for various finished dosage forms: pre-filled syringes liquid vials lyophilized vials cartridges From state-of-the-art facilities, MabLaunch TM will be in a position to supply clinical and commercial products on a worldwide basis. According to customer needs, associated services may range from standard transfer activities (scaling-up, analytical transfer, stability studies ) to specific support on technical issues, such as dosage form switch or compatibility studies, by experienced industrial and pharmaceutical teams.

5 MAbLaunch TM is your CMO Partner for biologics Key benefits : The advantages of large pharma combined with flexible CMO services Comprehensive and global offer of services for protein-based biopharmaceuticals, from mammalian cell line to optimization of cell culture conditions and process at small scale to preclinical, clinical and commercial manufacturing of drug substance and drug product An integrated, dual platform approach, which is fully adaptable to customer needs, offering the most suitable solution for each project, from small to large production quantities Extensive experience in evaluation, optimization and scale-up; avoiding unnecessary costs and delays in Successful production track records for pre-clinical, clinical and commercial supply to biopharmaceutical companies Seamless integration: unified project management and quality assurance systems Thorough regulatory and QA support, including full documentation and controls at all steps of and manufacturing Optimized entry cost and long-term cost effectiveness management Program management and regulatory support MAbLaunch TM understands the need to be at the forefront of s in the field of Quality Assurance and Regulatory Affairs as well as the importance of transferring this information to its clients. MAbLaunch TM has access to the expertise and experience of the Sanofi and LFB teams, in Quality Control, Quality Assurance, Regulatory and Program Management. Our quality systems are dedicated to providing high-value products and services which enable our customers to conduct a project with confidence. Each project is managed by a dedicated, experienced and multidisciplinary team who works in close collaboration with each customer to ensure that milestones are reached and that cost and timeline targets are met.

6 July 2013 Design and layout: PASAYA - Photographs: LFB & Sanofi, X LFB Biomanufacturing site Impasse des Chênes Rouges Alès cedex - France About LFB Group/ LFB Biomanufacturing LFB Group is a biopharmaceutical company, and the n 1 biotech French company. LFB Group is ranked as the fifth largest plasma-derived products player worldwide, and the third largest pharma company supplying drugs to hospitals in France. In the biotechnology field, LFB Group is developing monoclonal antibodies and a line of recombinant proteins using transgenic technology with GTC BioTherapeutics, a US based company. Founded in 1997, LFB Biomanufacturing is a fully integrated contract manufacturing organization based in Alès (southern France), specializing in GMP production of recombinant proteins and monoclonal antibodies using mammalian cell-based expression systems. Contacts MAbLaunch TM Sanofi site 9 Quai Jules Guesde Vitry sur Seine - France About Sanofi/BioLaunch Sanofi, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. BioLaunch building, Jacob Development & Jacob Production, is a major operation for Sanofi in France. An investment of nearly 200 million euros will give rise to the first cell culture biotechnology platform of the Group to produce monoclonal antibodies starting in This project is a core part of the conversion plan for the Vitry-sur-Seine site turning it into a comprehensive biotechnology platform that includes research, and production activities. Furthermore, Sanofi has decided to open this platform to other companies, on the basis of their or production needs. Patrick Haddad Roland BELIARD Global: Philippe CLAVEL Europe: Arnaud Martin North America: John FULMER Japan: Hikaru OHSAWA

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

EMABling Antibody Production Platform

EMABling Antibody Production Platform EMABling Antibody Production Platform An industrial solution for the production of therapeutic antibodies with high cytotoxic activity B IOMANUFACTURING EMABling : A fully integrated development platform

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

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

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

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

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

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

Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform

Eden Biodesign ebook Monoclonal Antibody Production: Building the Platform 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

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

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

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

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

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

From cells to therapeuticsvivalis. Humalex Fully human antibody discovery platform An integrated therapeutic development offering

From cells to therapeuticsvivalis. Humalex Fully human antibody discovery platform An integrated therapeutic development offering From cells to therapeuticsvivalis Humalex Fully human antibody discovery platform An integrated therapeutic development offering Humalex from bench-top to clinical development The Humalex platform enables

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

Biopharmaceutical Contract Manufacturing

Biopharmaceutical Contract Manufacturing S TAT E N S S E R U M I N S T I T U T Biopharmaceutical Contract Manufacturing Your Requirements Our Commitment UnderTitel SSI-Image-Brochure.indd Sec2:1 1 05-07-2007 07:31:31 Introduction Statens Serum

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

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

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

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

Cell Discovery 360: Explore more possibilities.

Cell Discovery 360: Explore more possibilities. Cell Discovery 360: Explore more possibilities. Flexible solutions for the BioPharma laboratory Blood Banking Capillary Electrophoresis Centrifugation Flow Cytometry Genomics Lab Automation Lab Tools Particle

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

Pharma & Biotech processes: global turnkey solutions

Pharma & Biotech processes: global turnkey solutions Pharma & Biotech processes: global turnkey solutions 02 Our mission: to design and build turnkey process solutions AS A LEADING-EDGE INDUSTRIAL INTEGRA- TOR, BOCCARD DESIGNS AND BUILDS UNIQUE PHARMACEUTICAL

More information

ATGCell. ATGCell Inc.

ATGCell. ATGCell Inc. ATGCell Inc. http://www.atgcell.com Corporate ATGCell is a revenue generating spin-off biotech company from University of Alberta. Incorporated in September 2007; 6 employees (5 PhD and 1 MSc); several

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

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

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

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

Improving GS-CHO Cell Line Selection: Reducing Time to Clinic

Improving GS-CHO Cell Line Selection: Reducing Time to Clinic Cell Line Development and Engineering 2-6 March 2009, Berlin Improving GS-CHO Cell Line Selection: Reducing Time to Clinic Adrian Haines, 2009 Lonza Biologics plc, Slough, UK Disclaimer Certain matters

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

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

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

How Long Does it Take to Manufacture Plasmid under GMP?

How Long Does it Take to Manufacture Plasmid under GMP? How Long Does it Take to Manufacture Plasmid under GMP? Manufacturing plasmid under GMP generally takes four to nine months, depending upon your project s specific requirements. You may be wondering, Why

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

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

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

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

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

Host cell Protein Clearance and Detection: Critical issues for Biopharmaceutical development

Host cell Protein Clearance and Detection: Critical issues for Biopharmaceutical development Host cell Protein Clearance and Detection: Critical issues for Biopharmaceutical development Protein Quantification workshop, Waters: 13 th November 2012 Vincent Monchois, R&D and Pilot Services Manager,

More information

Dedicated Project Management

Dedicated Project Management Peptides Dedicated Project Management At Lonza, we are committed to our customers success, so it is our mission to help your product reach its full potential. We pride ourselves on delivering high-quality,

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

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

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

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

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

Products For Cell Line Development

Products For Cell Line Development Products For Cell Line Development Table of Contents 3 ClonaCell Products for Cell Line Development 4 Semi-Solid Cloning for Cell Line Development 5 Semi-Solid Cloning Delivers a High Probability of Monoclonality

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

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

MAB Solut. MABSolys Génopole Campus 1 5 rue Henri Desbruères 91030 Evry Cedex. www.mabsolut.com. is involved at each stage of your project

MAB Solut. MABSolys Génopole Campus 1 5 rue Henri Desbruères 91030 Evry Cedex. www.mabsolut.com. is involved at each stage of your project Mabsolus-2015-UK:Mise en page 1 03/07/15 14:13 Page1 Services provider Department of MABSolys from conception to validation MAB Solut is involved at each stage of your project Creation of antibodies Production

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

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

Continuous Bioprocessing Barcelona Spain

Continuous Bioprocessing Barcelona Spain Continuous Bioprocessing Barcelona Spain Continuous Processing in Biotech Production: An alternative to a modern single use, batch, facility? Thomas Daszkowski, Bayer Technology Services Page 1 21.10.

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

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

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

Biopharm Roundtable. 1. What, in your opinion, is currently the single largest trend with respect to biopharmaceutical outsourcing and manufacture?

Biopharm Roundtable. 1. What, in your opinion, is currently the single largest trend with respect to biopharmaceutical outsourcing and manufacture? BIOPHARM ROUNDTABLE Biopharm Roundtable Morrey Atkinson Vice President, R&D Cook Pharmica Peter Soelkner Managing Director Vetter Pharma-Fertigung GmbH & Co. KG Johannes Reiter Cooperations Manager Sandoz

More information

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) 22 May 2014 EMA/CHMP/BWP/247713/2012 Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance:

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

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

BioBusiness Biopharmaceutical Ingredients Recombinant albumins & albumin fusion Dermot Pearson, Strategic Product Director, NZ Biopharma

BioBusiness Biopharmaceutical Ingredients Recombinant albumins & albumin fusion Dermot Pearson, Strategic Product Director, NZ Biopharma BioBusiness Biopharmaceutical Ingredients Recombinant albumins & albumin fusion Dermot Pearson, Strategic Product Director, NZ Biopharma 2 Novozymes solutions dedicated to the biopharmaceutical industry

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

Protein Expression in CHO cells: Comparison of GPEx to a Traditional Cell Line Engineering Technology

Protein Expression in CHO cells: Comparison of GPEx to a Traditional Cell Line Engineering Technology Protein Expression in CHO cells: Comparison of GPEx to a Traditional Cell Line Engineering Technology Why is GPEx Technology Unique and Differentiated? Versatile Works on any mammalian cell line, and many

More information

National Institute for Bioprocessing Research and Training (NIBRT)

National Institute for Bioprocessing Research and Training (NIBRT) NIBRT Catalogue 2013 2012 Training Education Training and Education Catalogue National Institute for Bioprocessing Research and Training (NIBRT) www.nibrt.ie Contents Welcome letter 1 Open courses... 3

More information

Caponago EXPERTS TAKING CARE

Caponago EXPERTS TAKING CARE CordenPharma Caponago EXPERTS TAKING CARE Our History 1970 Foundation by ICI Pharma 1987 Expansion by Astra Zeneca to accommodate Diprivan (propofol) 1992 First FDA approval 2009 Latest Anvisa (Brasilian)

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

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

LABELMANAGEMENT WITH SAP - INTEGRATION

LABELMANAGEMENT WITH SAP - INTEGRATION LABELMANAGEMENT WITH SAP - INTEGRATION Vetter Pharma-Fertigung GmbH & Co. KG LABELING SOLUTIONS FOR PROFESSIONALS SAP Labelmanagement from OPAL and BarTender label software from Seagull Scientific ensure

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

Recombinant Protein Expression Services

Recombinant Protein Expression Services Recombinant Protein Services High quality recombinant protein for your research www.genscript.com GenScript USA Inc. 860 Centennial Ave. Piscataway, NJ 08854 USA Email: orders@genscript.com Toll-Free:

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

ESTABLISHMENT OF CELL LINES FOR MANUFACTURING RECOMBINANT ANTIBODIES. Dr Andrew Racher

ESTABLISHMENT OF CELL LINES FOR MANUFACTURING RECOMBINANT ANTIBODIES. Dr Andrew Racher ESTABLISHMENT OF CELL LINES FOR MANUFACTURING RECOMBINANT ANTIBODIES Dr Andrew Racher Lonza Biologics plc, 2004 Structure of talk Issues Selection of a high producing cell line Selection for process compatibility

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

Production in an Innovation Economy: The Globalization of Biomanufacturing and Implications for the Geography of Innovation

Production in an Innovation Economy: The Globalization of Biomanufacturing and Implications for the Geography of Innovation Production in an Innovation Economy: The Globalization of Biomanufacturing and Implications for the Geography of Innovation Industry Studies Association Pittsburgh, June 1, 2011 Elisabeth Reynolds, Ph.D.

More information

CUSTOMER ORIENTED TOLL MANUFACTURING TAILORED SERVICES INTERACTIVE PROJECT MANAGEMENT CUSTOM SYNTHESIS & API CONTRACT MANUFACTURING

CUSTOMER ORIENTED TOLL MANUFACTURING TAILORED SERVICES INTERACTIVE PROJECT MANAGEMENT CUSTOM SYNTHESIS & API CONTRACT MANUFACTURING CUSTOMER ORIENTED TOLL MANUFACTURING TAILORED SERVICES INTERACTIVE PROJECT MANAGEMENT CUSTOM SYNTHESIS & API CONTRACT MANUFACTURING CEPiA Within the Industrial Affairs Division of Sanofi, CEPiA (Commercial

More information

Plant Solutions for Next Generation Biopharmaceuticals and Regenerative Medicine

Plant Solutions for Next Generation Biopharmaceuticals and Regenerative Medicine 676 Hitachi Review Vol. 64 (2016), No. 10 Featured Articles Plant Solutions for Next Generation Biopharmaceuticals and Regenerative Medicine Haruo Suzuki Yukio Fukushima Tadatoshi Iwabuchi Yoshinori Momota

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

LifeTein in Industrial Production of Therapeutic Peptides. Phil Moore, PhD Director of Business Development LifeTein LLC, NJ, USA

LifeTein in Industrial Production of Therapeutic Peptides. Phil Moore, PhD Director of Business Development LifeTein LLC, NJ, USA LifeTein in Industrial Production of Therapeutic Peptides Phil Moore, PhD Director of Business Development LifeTein LLC, NJ, USA 1 Outline Market and Technology Trend LifeTein s Technology portfolio LifeTein

More information

Liquids Suspensions Gels

Liquids Suspensions Gels Liquids Suspensions Gels EMCM: your product development and manufacturing partner Centre of excellence European Medical Contract Manufacturing (EMCM) is the centre of excellence in developing and manufacturing

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

The authors: Howard L. Levine, Ph.D., President and Founder. Thomas C. Ransohoff, Senior Consultant

The authors: Howard L. Levine, Ph.D., President and Founder. Thomas C. Ransohoff, Senior Consultant The authors: Howard L. Levine, Ph.D., President and Founder Dr. Levine has over 20 years of experience in the biopharmaceutical industry. Prior to founding BioProcess Technology Consultants to provide

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

Go for the complete package.

Go for the complete package. Go for the complete package. Our services help you stand out in the market. Individual design options while leveraging the benefits of a device platform Flexible prototyping and devices for early studies

More information

Quality and Safety Evaluation of Gene Therapy Products in Japan

Quality and Safety Evaluation of Gene Therapy Products in Japan Quality and Safety Evaluation of Gene Therapy Products in Japan Review Mechanism for Gene Therapy in Japan The review mechanism for gene therapy in Japan was partially amended to simplify the necessary

More information

Custom Antibodies & Recombinant Proteins

Custom Antibodies & Recombinant Proteins Custom Antibodies & Recombinant Proteins INTRODUCTION Custom services to meet your research and development requirements Improvements in health, medicine and diagnostics over the past century can be largely

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

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

Large-scale Cell and Gene Therapy Catapult manufacturing facility for current

Large-scale Cell and Gene Therapy Catapult manufacturing facility for current Large-scale Cell and Gene Therapy Catapult manufacturing facility for current and future multiproduct processes October 2016 The Catapults Part of a world-leading network of technology and innovation centres

More information

Single-use bioprocessing

Single-use bioprocessing FOCUS ON... DISPOSABLES Upstream Single-Use Bioprocessing Systems Future Market Trends and Growth Assessment by Ronald A. Rader and Eric S. Langer Single-use bioprocessing equipment has become wellaccepted

More information

Risk-Based Change Management Using QbD Principles

Risk-Based Change Management Using QbD Principles Risk-Based Change Management Using QbD Principles Lynne Krummen, Ph.D. VP, Global Head, Technical Regulatory Biologics Genentech, a member of the Roche Group CMC Forum 2013 Tokyo, Japan Presentation Outline

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

A full integrated ready to use solution for your aseptic manufacturing

A full integrated ready to use solution for your aseptic manufacturing A full integrated ready to use solution for your aseptic manufacturing Company Profile Ompi is the Pharmaceutical Systems division of Stevanato Group. It offers a unique expertise in providing superior

More information

How single-use connections advance aseptic processing: Increased process flexibility and reliability, reduced costs

How single-use connections advance aseptic processing: Increased process flexibility and reliability, reduced costs WHITE PAPER 7004 How single-use connections advance aseptic processing: Increased process flexibility and reliability, reduced costs By John Boehm Business Unit Manager Colder Products Company Today s

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

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION The European Agency for the Evaluation of Medicinal Products London, 1 March 2001 CPMP/QWP/848/96 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)

More information

2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility. IDT Biologika 2015 FOYA Award Facility Integration

2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility. IDT Biologika 2015 FOYA Award Facility Integration 2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility 1 Agenda ABOUT IDT BIOLOGIKA FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES BUILDING CONCEPT AND PROJECT OVERVIEW

More information

Challenges and Opportunities of Monoclonal Antibody Manufacturing in China

Challenges and Opportunities of Monoclonal Antibody Manufacturing in China BioPharma Antibody Therapeutics News Digest Challenges and Opportunities of Monoclonal Antibody Manufacturing in China Chris Chen Introduction About the Author: Dr. Chris Chen is currently Chief Operating

More information

Implementation of Advanced Chromatography techniques to Mitigate Purification Concerns in Bispecific Monoclonal Antibody Manufacturing

Implementation of Advanced Chromatography techniques to Mitigate Purification Concerns in Bispecific Monoclonal Antibody Manufacturing www.beroe- WHITEPAPER December 2012 inc.com Implementation of Advanced Chromatography techniques to Multi Column Solvent Gradient Purification or MCSGP chromatography process is a better solution to Bispecific

More information

enzyme technologies Catalogue 2014 R&D Services protein analysis and engineering For service updates visit

enzyme technologies Catalogue 2014 R&D Services protein analysis and engineering For service updates visit enzyme technologies Catalogue 2014 R&D Services protein analysis and engineering For service updates visit www.enantis.com Content Company profile 3 Protein production 4 Protein analysis 6 Protein engineering

More information

Bio-manufacturing of antigens, antibodies and bioresearch materials

Bio-manufacturing of antigens, antibodies and bioresearch materials Bio-manufacturing of antigens, antibodies and bioresearch materials Foetal Bovine Serum (FBS) Human AB Serum Chick Embryo Extract (CEE) Custom polyclonal antibody production Custom monoclonal antibody

More information