Microbial Biopharmaceutical Services

Size: px
Start display at page:

Download "Microbial Biopharmaceutical Services"

Transcription

1 Pharma&Biotech Your Destination Is Our Goal for Microbial Expression

2 Pharma&Biotech for Microbial Expression Partner of Choice for Microbial Expression Lonza has over 30 years of experience in microbial fermentation for microbial-derived biopharmaceuticals. As a leading manufacturing service provider, we strive to match our customer s requirements with a complete line of service offerings throughout the product development cycle. With our state-of-the-art technology and industry-leading expertise, Lonza has developed an unparalleled track record in establishing high quality, commercially viable processes spanning from pre-clinical development through commercial scale manufacturing. Lonza s Microbial Track Record (1997 Present) Recombinant vaccines Plasmid DNA Antibody fragments Antibody drug conjugates Cytokines Growth factors Hormones Polysaccharide Protein conjugates Products requiring BSL 2 PEGylated products Fusion proteins Protein scaffolds Concatemer peptides 6 Commercially Licensed Projects 89 Pre-clinical & Phase I Projects 26 Phase II/III Projects 2

3 XS Microbial Expression Technology : A Portfolio of Advanced Expression Options XS Technology Tool Box To address the diversity of microbially derived proteins, Lonza has established the XS Microbial Expression Technology Platform, a collection of complementary expression systems that have a proven ability to express recombinant proteins at levels in excess of 20 g/l. The power of our XS Technology is the variety of expression options available to discover the best solution for a given product. XS Expression Technologies E. coli Pichia Bacillus Our portfolio of powerful microbial expression tools encompasses Escherichia coli, Pichia pastoris, and Bacillus subtilis. This diversity of systems enables the delivery of high expression levels for a variety of product types. We use high-throughput screening to identify the best production clone for your product, and have programs designed to go from gene to cgmp production in as little as 7 months. Sugar Inducible GAP Constitutive Sugar Inducible Depletion Inducible Strong Constitutive Auto Inducible Optimized IPTG Inducible Methanol Inducible Glucose Regulated

4 Pharma&Biotech for Microbial Expression Complete Optimization for Better Results When using the XS Technology Platform, you have multiple options for optimizing the expression of your chosen molecule. Each XS Platform offers a range of properties that may be suitable for your selected target. In addition, our XS toolbox allows you to optimize your titers and development timelines while creating a reliable process for future production at increased scale. For customers who are interested in developing their own strains in their facility, our E. coli / sugar inducible system is available under a Research Evaluation Agreement. Lonza s microbial experts will work with you to optimize your expression within the proper host system to provide you with optimal conditions suited to your product. Proven Results for Optimized Yields, Titers and Process Reliability High-yielding Up to 20 g/l for monomeric proteins Up to 1.4 g/l for FAbs Up to 600 mg/l for pdna (6kb) Expression of FAbs with XS Technologies FAb concentration (mg /L) Time (h) FAb 1 FAb 2 FAb 3 Fig. 2 Protein concentration for 10 L fed-batch fermentation runs for three different FAb molecules using the following E. coli XS Technologies : Depletion induction (FAb1), Melibiose induction (FAb2) and Rhamnose induction (FAb3). The cells were harvested, homogenized and the FAb titer was determined by HPLC. Soluble Expression Stable Scalable Fast Inclusion body-free processes Higher yields Reliable DSP No refold tanks Stabilizing genetic elements deliver reliable, predictable & scalable high cell density fermentations Platform fed-batch fermentation procedures are optimized for predictable scale-up Hundreds of host-vector combinations are screened to identify the best production clone within 10 weeks Properties of the Various XS Expression Technology Platforms XS Expression Systems E. coli Pichia Bacillus High Titers Makes Fabs Soluble Expression Stable Scalable Secretes Product Endotoxin Free Lacks Glycosylation Species Approved by FDA Yes Sometimes No «We offer unparalleled versatility throughout your entire development process.» 4

5 Beyond Proteins Plasmid DNA Production Platform: An Integrated Approach Lonza s pdna production platform includes an integrated approach to process development. The platform begins with a unique, fed-batch, high cell density fermentation process compatible with common industry options of E. coli host organisms. This high yielding fermentation process (up to 600 mg/l) is followed by an efficient and economic primary recovery process. Finally, a unique, two column purification platform, based on the differential power of hydrophobic interaction chromatography, has been adopted. Use of this platform process reduces development time required for custom pdna products compared to existing systems. «Innovation is in our nature.» Comprehensive Development Services Lonza understands that the road to an efficient commercial manufacturing process starts with high quality early candidate assessment along with an optimized process development program. Our multi-disciplinary Applied Protein Services and Process Development teams are focused on product manufacturability, economic viability, and conformation to the regulatory requirements right from the beginning. The Services We Offer Include: Immunogenicity prediction, assessment and protein engineering Strain design, construction and selection Strain characterization cgmp cell banking Fermentation and recovery development Refold optimization Filtration and chromatography development PEGylation process and analytical development A full range of analytical development and support Process characterization and validation activities Stability studies Reference standard characterization Regulatory support Non-GMP pilot manufacturing up to 70 L

6 Pharma&Biotech for Microbial Expression Global cgmp Production Our microbial development and production sites offer a wide range of ISO certified and cgmp custom services. Please visit our Virtual Tours at for a comprehensive viewing of our Custom Manufacturing facilities. Visp, Switzerland 20 L, 70 L, L (BL-2 product handling), L (expansion planning under way for additional mid- and large-scale capacity) Cytotoxic fermentation assets: 60 L, 250 L, L Kouřim, Czech Republic L, L, L (oral grade only) Our facilities conform to cgmp standards and have been successfully audited by customers and regulatory authorities. Structured Technology Transfer Through systematic and closely regulated operational and documentation processes, managed by dedicated product managers, we design and implement seamless technology transfer from your facility to our development and manufacturing sites. To date, we have transferred numerous clinical and commercial production processes. These transfers have covered scale-up factors from 5 to over 100 and scales ranging from 20 L to L. Quality Product Management Lonza s dedicated product management is a vital part of your product success. A product manager is your key contact providing continuous effective communication throughout the product lifecycle. Lonza s product management provides an integrated approach across the production value chain: from R&D to logistics and through quality assurance and manufacturing. You will be pleased with the ease of project administration without compromising efficiency or quality. Our commitment to providing you with both time and cost efficiencies during manufacturing will allow you to optimize your project. 6

7 Meeting Your Early Development Needs: Light Path Custom Material Supply The Complete Solution for Your Microbial Needs Light Path Discovery Drug Discovery mg, non GMP In 6 to 10 weeks Preclinical Development Phase I Lonza provides a complete development and manufacturing solution designed to fully realize your product potential in a timely and costeffective manner. With our diverse and proven technology platforms, experienced team of expression specialists and comprehensive product management personnel, we are committed to advancing your microbially derived products from the laboratory to the clinic and beyond. Light Path Development g, non GMP In 4 to 8 month g, GMP in 3 to 6 additional months Our newest service package, called Light Path Custom Material Supply, has been designed for customers whose short-term early stage goals are of paramount importance and who still want access to Lonza s renowned experience, experts, facilities and technologies. This efficient and focused material supply service offering for early stage development of novel biologics gives customers a simpler, faster, and more cost-effective way to obtain biological material. When you are ready to file your IND, you can leverage Lonza s proven technology platforms & expertise to meet your exact early development needs in a lean and speedy manner. Light Path Custom Material Supply Services offer complete gene to GMP production for both the Discovery Phase (mg of material non-gmp) and Development Phase (mg to kg of non-gmp and GMP material). Light Path allows you to partner with Lonza early and be on the road to a marketable product. Light Path Discovery Offering Includes: Options to use XS Technologies or client-provided strain Expression of tagged or untagged native proteins Affinity chromatography to purify tagged proteins No license fees Light Path Development Offering Include: Option to use XS Technologies or client-provided strain GMP Scale-up options from 20 L to 1000 L No license fees 7

8 Europe Lonza Ltd Muenchensteinerstrasse Basel, Switzerland Tel USA Lonza Inc. 90 Boroline Road Allendale, NJ Tel The information contained herein is believed to be correct and corresponds to the latest state of scientific and technical knowledge. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information. Some products may not be available in all markets or for every type of application. Any user must make his own determination and satisfy himself that the products supplied by Lonza Group Ltd and the information and recommendations given by Lonza Group Ltd are (i) suitable for intended process or purpose, (ii) in compliance with environmental, health and safety regulations, and (iii) will not infringe any third party s intellectual property rights Lonza Ltd

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

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

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

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

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

Bioservices. Your lab just got bigger

Bioservices. Your lab just got bigger Bioservices Your lab just got bigger Bioservices Expansive bioservices with a global advantage Lonza Bioservices emphasizes accuracy, precision and specificity to provide shortened delivery times and increased

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

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

Expression and Purification of Recombinant Protein in bacteria and Yeast. Presented By: Puspa pandey, Mohit sachdeva & Ming yu

Expression and Purification of Recombinant Protein in bacteria and Yeast. Presented By: Puspa pandey, Mohit sachdeva & Ming yu Expression and Purification of Recombinant Protein in bacteria and Yeast Presented By: Puspa pandey, Mohit sachdeva & Ming yu DNA Vectors Molecular carriers which carry fragments of DNA into host cell.

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

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

Bio-Reagents Gene synthesis Peptide Synthesis Protein Expression Antibody Production. Life Science Products and Services

Bio-Reagents Gene synthesis Peptide Synthesis Protein Expression Antibody Production. Life Science Products and Services Bio-Reagents Gene synthesis Peptide Synthesis Protein Expression Antibody Production Life Science Products and Services Since 2002, Biomatik has provided worldwide researchers in life science discovery

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

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

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

Custom Antibody Services

Custom Antibody Services Custom Antibody Services Custom service offerings DNA sequence Plasmid Peptide Structure Protein Peptide Small molecule Cells Spleen Lymphocytes Antigen Preparation Immunization Fusion & Subcloning Expansion

More information

HuCAL Custom Monoclonal Antibodies

HuCAL Custom Monoclonal Antibodies HuCAL Custom Monoclonal Antibodies Highly Specific Monoclonal Antibodies in just 8 Weeks PROVEN, HIGHLY SPECIFIC, HIGH AFFINITY ANTIBODIES IN 8 WEEKS WITHOUT HuCAL PLATINUM IMMUNIZATION (Human Combinatorial

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

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

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

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

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

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

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

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

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

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

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

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

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

CUSTOM ANTIBODIES. Fully customised services: rat and murine monoclonals, rat and rabbit polyclonals, antibody characterisation, antigen preparation

CUSTOM ANTIBODIES. Fully customised services: rat and murine monoclonals, rat and rabbit polyclonals, antibody characterisation, antigen preparation CUSTOM ANTIBODIES Highly competitive pricing without compromising quality. Rat monoclonal antibodies for the study of gene expression and proteomics in mice and in mouse models of human diseases available.

More information

Aviva Systems Biology

Aviva Systems Biology Aviva Custom Antibody Service and Price Mouse Monoclonal Antibody Service Package Number Description Package Contents Time Price Customer provides antigen protein $6,174 Monoclonal package1 (From protein

More information

"Small and large molecules bioproduction by mammalian and microbial fermentation"

Small and large molecules bioproduction by mammalian and microbial fermentation "Small and large molecules bioproduction by mammalian and microbial fermentation" H.-P. Meyer Bio/PharMOS 2004-23-25 March 2004 Symposium B Business Diversification in Life Science "Small and large molecules

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

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

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

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

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

Brand Quality with Asian Advantages

Brand Quality with Asian Advantages Brand Quality with Asian Advantages ScinoPharm Taiwan, Ltd. No.1, Nan-Ke 8th Road, Tainan Science Park, Shan-Hua, Tainan, 74144, Taiwan TEL : 886-6-505-2888 FAX : 886-6-505-2898 Email Contact : mkt@scinopharm.com

More information

HuCAL Custom Monoclonal Antibodies

HuCAL Custom Monoclonal Antibodies HuCAL Custom Monoclonal HuCAL Custom Monoclonal Antibodies Highly Specific, Recombinant Antibodies in 8 Weeks Highly Specific Monoclonal Antibodies in Just 8 Weeks HuCAL PLATINUM (Human Combinatorial Antibody

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

3 months 1.5 months 1.5 months. 1 month

3 months 1.5 months 1.5 months. 1 month Rabbit monoclonal antibody (Mab) is secreted by the plasma B-cell of the rabbit. Traditional generation of rabbit Mab relies on a rabbit myeloma for B- cell fusion (

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

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

Expression Systems for Peptide Production

Expression Systems for Peptide Production Expression Systems for Peptide Production Susanna Leong School of Chemical and Biomedical Engineering, Nanyang Technological University, Singapore CBAS, 17-19 July 2007 (Source: Lonza Ltd., Basel, Switzerland)

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

How To Make A Drug From A Peptide

How To Make A Drug From A Peptide MODERN PERSPECTIVES ON PEPTIDE SYNTHESIS INTRODUCTION WHITEPAPER www.almacgroup.com The complexity of synthetic peptide products, whether as reagents used in research or as therapeutic APIs, is increasing.

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

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

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

Aviva Systems Biology

Aviva Systems Biology Aviva Custom Antibody Services and Prices Rabbit Polyclonal Antibody Service Package Number Description Package Contents Time Price Polyclonal package 1 (From protein to antiserum) Polyclonal package 2

More information

Recombinant Antibody Fragments, Brochure

Recombinant Antibody Fragments, Brochure Recombinant Antibody Fragments, Brochure Interest in any of the products, request or order them at Bio-Connect Diagnostics. Bio-Connect Diagnostics B.. T NL +31 (0)26 326 44 60 T BE +32 (0)2 502 12 53

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

Your partner in immunology

Your partner in immunology Your partner in immunology Expertise Expertise Reactivity Reactivity Quality Quality Advice Advice Who are we? Specialist of antibody engineering Covalab is a French biotechnology company, specialised

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

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

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

Accelerating Antibody Process Development: Exploring the Synergies Between Engineered Host Cells and Process Development

Accelerating Antibody Process Development: Exploring the Synergies Between Engineered Host Cells and Process Development Pharma&Biotech Accelerating Antibody Process Development: Exploring the Synergies Between Engineered Host Cells and Process Development James Rance PhD Head of Development Services Singapore Lonza Biologics

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

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

BIOSIMILARS A COMPLETE DEVELOPMENT PLATFORM

BIOSIMILARS A COMPLETE DEVELOPMENT PLATFORM BIOSIMILARS A COMPLETE DEVELOPMENT PLATFORM FROM ORIGINATOR THROUGH COMPARABILITY TO MARKET STREAMLINE YOUR R&D, REGULATORY, ANALYTICAL, AND CLINICAL NEEDS WITH ONE PROVIDER The development pathway of

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

Presented at: Jefferies 2015 Global Healthcare Conference

Presented at: Jefferies 2015 Global Healthcare Conference Presented at: Jefferies 2015 Global Healthcare Conference Agenda 1 Overview & Service Platforms 2 Adaptability, Scalability & Expansion Plans 3 Best Practices 4 Blue Chip Customer Base 5 Roadmap of Evolution

More information

Analyzing antibody sequence for recombinant antibody expression. Hangxing Yu, Ph.D Senior Scientist, GenScript May 20, 2015

Analyzing antibody sequence for recombinant antibody expression. Hangxing Yu, Ph.D Senior Scientist, GenScript May 20, 2015 Analyzing antibody sequence for recombinant antibody expression Hangxing Yu, Ph.D Senior Scientist, GenScript May 20, 2015 Presentation Outline 1 2 3 4 Antibody basics, structure and function Antibody

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

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

Non-clinical development of biologics

Non-clinical development of biologics Aurigon Life Science GmbH Non-clinical development of biologics Requirements, challenges and case studies Committed to Life. Sigrid Messemer vet. med. M4 Seminar March 10 th 2014 Aurigon - your full service

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

Protein Expression. A Practical Approach J. HIGGIN S

Protein Expression. A Practical Approach J. HIGGIN S Protein Expression A Practical Approach S. J. HIGGIN S B. D. HAMES List of contributors Abbreviations xv Xvi i 1. Protein expression in mammalian cell s Marlies Otter-Nilsson and Tommy Nilsso n 1. Introduction

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Q5B

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Q5B INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS

More information

FACULTY OF MEDICAL SCIENCE

FACULTY OF MEDICAL SCIENCE Doctor of Philosophy Program in Microbiology FACULTY OF MEDICAL SCIENCE Naresuan University 171 Doctor of Philosophy Program in Microbiology The time is critical now for graduate education and research

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

European Medicines Agency

European Medicines Agency European Medicines Agency July 1996 CPMP/ICH/139/95 ICH Topic Q 5 B Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for Production of r-dna Derived Protein

More information

Molecular Biology Techniques: A Classroom Laboratory Manual THIRD EDITION

Molecular Biology Techniques: A Classroom Laboratory Manual THIRD EDITION Molecular Biology Techniques: A Classroom Laboratory Manual THIRD EDITION Susan Carson Heather B. Miller D.Scott Witherow ELSEVIER AMSTERDAM BOSTON HEIDELBERG LONDON NEW YORK OXFORD PARIS SAN DIEGO SAN

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

GenScript Antibody Services

GenScript Antibody Services GenScript Antibody Services Scientific experts, innovative technologies, proven performance We specialize in custom antibody production to empower your research Custom Polyclonal Antibody Production Custom

More information

Our passion is to deliver sustainable value to our customers 2007 First Half Results 26 July 2007

Our passion is to deliver sustainable value to our customers 2007 First Half Results 26 July 2007 Our passion is to deliver sustainable value to our customers 2007 First Half Results 26 July 2007 Toralf Haag Chief Financial Officer Disclaimer Certain matters discussed in this presentation may constitute

More information

Custom Antibodies Services. GeneCust Europe. GeneCust Europe

Custom Antibodies Services. GeneCust Europe. GeneCust Europe GeneCust Europe Laboratoire de Biotechnologie du Luxembourg S.A. 6 rue Dominique Lang L-3505 Dudelange Luxembourg Tél. : +352 27620411 Fax : +352 27620412 Email : info@genecust.com Web : www.genecust.com

More information

Antibody Services. Best Guarantees in the Industry! Monoclonal Antibody Services. Polyclonal Antibody Services. Express Antibody TM Services

Antibody Services. Best Guarantees in the Industry! Monoclonal Antibody Services. Polyclonal Antibody Services. Express Antibody TM Services Antibody Services Best Guarantees in the Industry! Monoclonal Antibody Services Polyclonal Antibody Services Express Antibody TM Services Guaranteed Antibody Services Antibody Purification Services Your

More information

H y B rid i Z ation- elis a. elis a. Bioanalytical o verview. ecl

H y B rid i Z ation- elis a. elis a. Bioanalytical o verview. ecl lc- icp-ms lc-ms/ms G yros H y B rid i Z ation- elis a elis a Bioanalytical o verview ecl icp-ms Bioanalytical Overview One of the world s largest offerings for bioanalysis of small molecules and biologics,

More information

A customizable ADCC assay service for antibodies & fusion proteins.

A customizable ADCC assay service for antibodies & fusion proteins. Antibody Dependent Cell- Mediated Cytotoxicity (ADCC) Assay A customizable ADCC assay service for antibodies & fusion proteins. Our ADCC assay service accurately detects cell lysis based on LDH-release.

More information

Heterologous expression and purification of proteins in E. coli

Heterologous expression and purification of proteins in E. coli Heterologous expression and purification of proteins in E. coli Rory Koenen Institut für molekulare Herz-Kreislaufforschung University Hospital of the RWTH Aachen rkoenen@ukaachen.de Tel. 35984 contents

More information

Challenges in Industrial Production of Peptides. Dr. Daniel Bourgin Director of Sales & BD LCM-TIDES, Lonza Ltd. Basel, Switzerland

Challenges in Industrial Production of Peptides. Dr. Daniel Bourgin Director of Sales & BD LCM-TIDES, Lonza Ltd. Basel, Switzerland Challenges in Industrial Production of Peptides Dr. Daniel Bourgin Director of Sales & BD LCM-TIDES, Lonza Ltd. Basel, Switzerland Agenda Market Trend Technology Trend Challenges Lonza s Technology portfolio

More information

AFFITECH and XOMA Sign Antibody Collaboration and Cross-License Agreement

AFFITECH and XOMA Sign Antibody Collaboration and Cross-License Agreement FOR IMMEDIATE RELEASE Ref 05AFF05 Contacts for Affitech: Contacts for XOMA Affitech (Norway): Investor Inquiries Dr. Martin Welschof Ellen M Martin Chief Executive Officer Kureczka/Martin Associates Phone:

More information

GenScript USA Inc. Open Position List

GenScript USA Inc. Open Position List GenScript USA Inc. is a world leader in developing and marketing innovative biotechnology products. Our dedication to innovation has led GenScript to generate a continuous flow of services and 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

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

Antibody Production Price List

Antibody Production Price List Antibody Production Price List Presenting Insight Biotechnology s price list for custom polyclonal and monoclonal antibody production services. We are happy to tailor individual packages towards the specific

More information

How To Develop A Cell Line

How To Develop A Cell Line 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

Guidance for Industry

Guidance for Industry Guidance for Industry Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation

More information

VMware Hybrid Cloud. Accelerate Your Time to Value

VMware Hybrid Cloud. Accelerate Your Time to Value VMware Hybrid Cloud Accelerate Your Time to Value Fulfilling the Promise of Hybrid Cloud Computing Through 2020, the most common use of cloud services will be a hybrid model combining on-premises and external

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

CHAPTER 6: RECOMBINANT DNA TECHNOLOGY YEAR III PHARM.D DR. V. CHITRA

CHAPTER 6: RECOMBINANT DNA TECHNOLOGY YEAR III PHARM.D DR. V. CHITRA CHAPTER 6: RECOMBINANT DNA TECHNOLOGY YEAR III PHARM.D DR. V. CHITRA INTRODUCTION DNA : DNA is deoxyribose nucleic acid. It is made up of a base consisting of sugar, phosphate and one nitrogen base.the

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

Selection of Cell Lines for Manufacturing Therapeutic Antibodies by Flow Cytometric Cell Sorting. Andrew Racher Lonza Biologics

Selection of Cell Lines for Manufacturing Therapeutic Antibodies by Flow Cytometric Cell Sorting. Andrew Racher Lonza Biologics Selection of Cell Lines for Manufacturing Therapeutic Antibodies by Flow Cytometric Cell Sorting Andrew Racher Lonza Biologics Structure of Talk 1. The Problem 2. Possible Solutions 3. Solution Chosen

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

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

novo nordisk Partnering for innovation IN PROTEIN-BASED THERAPEUTICS AND TECHNOLOGIES Protein Technologies Diabetes Protein Delivery Devices

novo nordisk Partnering for innovation IN PROTEIN-BASED THERAPEUTICS AND TECHNOLOGIES Protein Technologies Diabetes Protein Delivery Devices novo nordisk Partnering for innovation IN PROTEIN-BASED THERAPEUTICS AND TECHNOLOGIES Juan Jenny Li works as a chemistry professional at Novo Nordisk s research centre in Beijing Diabetes Protein Technologies

More information