Hosts for Biosimilars Production: What is the future?
|
|
- Judith Hancock
- 5 years ago
- Views:
Transcription
1 Hosts for Biosimilars Production: What is the future? Lloyd Ruddock, Scientific Director, Paras Biopharmaceuticals Finland Company executives meet and decide 10 year roadmap Biosimilars capabilities realized Paras Biopharmaceuticals Finland is conceptualized; details finalized Paras Biopharmaceuticals Finland is established and executives look for interested investment groups
2 Paras research labs Reproduced with permission from Helsinki University Collection Paras Business Paras Biopharmaceuticals Finland works on technology development for biosimilars and their out-licensing Paras has multiple products already in pipeline The aim is to deliver at least one product API to market per year starting in
3 Paras target areas Diabetes Rheumatoid Arthritis Osteoporosis } next All high-growth, high-value areas with multiple products coming off patent over the 6 years Paras novel technologies As well as utilizing existing local expertise, Paras has developed multiple novel technologies including: 1. Diabrid technology 2. Noble Cleav R 3. BioMultifold R 4. BioEnhanced R 3
4 Diabrid technology Paras propreity partner (PPP) Therapeutic Protein Promoter Linker Terminator Cleavage Diabrid Technology address two major problems in the biologics and therapeutic peptide industry: i) Higher cost of biologics production ii) Large scale production of long therapeutic peptides is very difficult, if not impossible by chemical synthesis. 30 years ago FDA approved first recombinant biologic 4
5 Sales In the early years prokaryotic production dominated the market Sales of proteins produced in prokaryotes e.g. E.coli have continued to increase Low cost Rapid growth High biomass Easy cultivation and manipulation FDA friendly 5
6 Market share In the last decade market share of sales for biologics production in eukaryotes rapidly increasing Increased yields prokaryotes Decreased costs Eukaryotes can produce some proteins, in an active state that prokaryotes cannot. eukaryotes Biologics production is predicted to continue to grow rapidly, but what will be the hosts in the future? 6
7 Biologics production is predicted to continue to grow rapidly, but what will be the hosts in the future? Will the market share from eukaryotes systems continue to increase, while prokaryotic production decreases? No simple generic perfect host 7
8 No simple generic perfect host Protein specific No simple generic perfect host Protein specific Both eukaryotic and prokaryotic production systems have their place 8
9 No simple generic perfect host Protein specific Both eukaryotic and prokaryotic production systems have their place Things are not as bleak for prokaryotic production as is sometimes made out Current rule of thumb: Intracellular proteins Prokaryotic production Extracellular proteins Eukaryotic production or Prokaryotic production + ex vivo refolding 9
10 In reality the issue is post translational modifications. PTM or not PTM, that is the question. Some PTMs can be added afterwards ex vivo e.g. amidation of the C-terminus R O H C C N C COOH H H H PAM R O C C N H H H 10
11 Disulfide bond formation and N-glycosylation are not PTMs Both are co-translational modifications Both are difficult to add after the protein has been synthesised Some textbooks imply only eukaryotes can make disulfide bonds and N-glycosylate proteins Strict requirement for eukaryotic production system or ex vivo refolding to allow correct disulfide bond formation 11
12 Periplasmic disulfide bond formation in E.coli Periplasmic N-glycosylation in E.coli Uses N-glycosylation systems introduced from other prokaryotes e.g. PglB from Campylobacter jejuni 12
13 This can be used to generate defined N-glycan structures by two distinct methods In vivo N-glycosylation + Ex vivo transglycosylation 13
14 Engineered pathways based on PglB promiscuity These are very successful for the production of some proteins 14
15 These are very successful for the production of some proteins Can also be used as a route for other site specific modifications e.g. pegylation Limitations of the periplasm: Low volume / low capacity => low yields (?) E.coli: Ronald Wetzel (SKB) 15
16 Limitations of the periplasm: Low volume / low capacity => low yields (?) E.coli: Ronald Wetzel (SKB) Ignicoccus hospitalis: Karl Stetter (Regensburg) Limitations of the periplasm: Low volume / low capacity => low yields (?) E.coli: Ronald Wetzel (SKB) Ignicoccus hospitalis: Karl Stetter (Regensburg) Secretion machinery easily overloaded 16
17 Cytoplasmic expression in E.coli is ideal for protein production, but limited PTMs Periplasmic expression in E.coli can allow missing PTMs, but yields may be low. => An increased market share for eukaryotic systems in future? There are systems for disulfide bond formation and N-glycosylation in the cytoplasm 17
18 Cytoplasmic expression Naturally reducing environment => inclusion bodies Pathways for disulfide bond reduction in E.coli cytoplasm X X 18
19 DtrxB Dgor strains Currently sold by Novagen (origami, rosetta-gami etc) and New England Biolabs (SHuffle). Disulfide bond formation inefficient and dependent on external factors. Yields of correctly folded protein often very low. Strains can grow slowly on rich media and not at all on minimal media. These strains remove reducing pathways. They do not add a pathway for catalyzing de novo disulfide bond formation 19
20 Either: Take core catalysts from eukaryotes and express in the cytoplasm Invert the natural systems present in prokaryotes so that they make disulfide bonds in the cytoplasm E.coli alkaline phosphatase 2 sequential disulfides, whose formation is essential for activity. Co-expression of Erv1p in a wild-type E.coli strain results in more active protein than rosetta-gami. Disulfide bonded 20
21 E.coli phytase 4 disulfides, 1 non-sequential. Model protein that requires an isomerase. It folds correctly if Erv1p and an isomerase are co-expressed. Disulfide bonded Human tissue plasminogen activator (tpa) kringle 2 + protease vtpa (9 disulfides, all non-sequential) 21
22 Human tissue plasminogen activator (tpa) kringle 2 + protease vtpa (9 disulfides, all non-sequential) This works in the cytoplasm of any E.coli strain Yields of up to 100mg/L of homogenously folded eukaryotic protein from shake flasks 22
23 The system is amenable to fermentation Human interleukin 6: 1.0 g/l purified product Human growth hormone 1: 1.1 g/l purified product scfv: 0.6g/L purified product Cytoplasmic N-glycosylation in E.coli Uses N-glycosylation system from Actinobacillus pleuropneumoniae 23
24 Several groups are now trying to combine cytoplasmic disulfide bond formation with cytoplasmic N-glycosylation, along with additional quality control systems. In effect they are mimicking the eukaryotic ER in the cytoplasm of a prokaryote. Why? 24
25 Eukaryotic N-glycan heterogeneity Eukaryotic proteins are often heterogenous in the number and types of N-glycans added, even on a single protein This has major implications since N-glycans can modulate: Biological activity Stability Clearance Eukaryotic N-glycan heterogeneity This can have some advantages, but is has a number of major disadvantages including: Significant batch to batch variation Biosimilars are not biosimilar 25
26 Summary Efficient disulfide bond formation +/- N-glycosylation in the cytoplasm of E.coli offers up new, interesting, possibilities for the industrial production of homogenous proteins in high yields. It will not replace eukaryotic protein production, but offers an alternative solution that may create an interesting balance between eukaryotic and prokaryotic expression of biosimilars. Paras product developments Multiple product pipeline with delivery of at least one product API to market each each Products in our pipeline include: - Lantus (Glargine) - Teriparatide - A rheumatoid arthritis product 26
27 Diabetes Paras pipeline products validation Validation of production by: Mass Spectrometry SDS-PAGE Osteoporosis Paras pipeline products validation Validation of production by: Mass Spectrometry SDS-PAGE Paras 7 (final product) 27
28 Rheumatoid Arthritis Paras pipeline product Paras 11 expresses product in high yields Purification of authentic product successful Purified yield equivalent to 0.7 kg from 500L Paras Pharmaceuticals Finland is looking for collaboration, out-licensing of technologies and partners. If interested please contact : Dr Inderjeet Kaur Director Biosimilars & Biologics Paras Biopharmaceuticals Finland Kurkelantie 5 C-43 Oulu, Finland ikaur@parasbiopharma.com 28
29 Acknowledgements: Paras Biopharmacuticals Finland research team Biocenter Oulu Paras advisory board For further information: or Paras Biopharmacuticals Finland Kurkelantie 5 C-43 Oulu Finland 29
2014 European Biopharmaceuticals Technology Innovation Leadership Award
2014 European Biopharmaceuticals Technology Innovation Leadership Award Technology Innovation Leadership Award The Biopharmaceuticals Industry EUROPE Frost & Sullivan 2 We Accelerate Growth Background
More informationProtein Expression PURIFICATION & ANALYSIS. be INSPIRED drive DISCOVERY stay GENUINE
Expression PURIFICATION & ANALYSIS be INSPIRED drive DISCOVERY stay GENUINE OVERVIEW Expression & Purification expression can be a very complex, multi-factorial process. Each protein requires a specific
More informationUpdate 2015/16. Protein Expression PURIFICATION & ANALYSIS
Update 2015/16 Expression PURIFICATION & ANALYSIS OVERVIEW Expression & Purification expression can be a very complex, multi-factorial process. Each protein requires a specific intracellular environment
More informationIncreasing Protein Stability
Increasing Protein Stability Stability depends on the extent of disulfide bond the presence of certain amino acids at the N terminus (Amino acids added to N terminus of β-galactosidase) (Table 6.4) Met,
More informationChaperone Co-expression Strategies for Soluble Protein Production in E. coli
Chaperone Co-expression Strategies for Soluble Protein Production in E. coli Bo Wu, Ph.D. Bo.Wu@genscript.com Table of Contents 1 2 3 4 5 6 E. Coli Expression Overview Inclusion Bodies & Refolding Expression
More informationE. coli and mammalian cells : most widely used
Host cells for the production of biopharmaceuticals Many of biopharmaceuticals, especially proteins : produced by recombinant DNA technology using various expression systems Expression systems : E. coli,
More informationModule 1 overview PRESIDENTʼS DAY
1 Module 1 overview lecture lab 1. Introduction to the module 1. Start-up protein eng. 2. Rational protein design 2. Site-directed mutagenesis 3. Fluorescence and sensors 3. DA amplification PRESIDETʼS
More informationPharma&Biotech. XS Microbial Expression Technologies Optimize Productivity, Speed and Process Robustness
Pharma&Biotech XS Microbial Expression Technologies Optimize Productivity, Speed and Process Robustness Embracing Complexity Based on 30 years of innovation in microbial biotechnology, Lonza offers the
More informationWhite Paper Authentic Recombinant Activin A and BMP- 4 Production Using HumanZyme s Proprietary Human Cell Line Expression Technology
White Paper Authentic Recombinant Activin A and BMP- 4 Production Using HumanZyme s Proprietary Human Cell Line Expression Technology Mark Azam, Ph.D. VP - R&D and Manufacturing Patricia Ahrweiler, Ph.D.
More informationKey and Criteria to the Selection of an Expression Platform
1 1 Key and Criteria to the Selection of an Expression Platform Gerd Gellissen, Alexander W.M. Strasser, and Manfred Suckow The production of recombinant proteins has to follow an economic and qualitative
More informationHeterologous protein expression systems
IMBB-FORTH Heterologous protein expression systems What are they? Protein expression systems producing desired polypeptides from recombinant genes. Plasmids carry and express the desired recombinant genes
More informationSUMOstar Gene Fusion Technology
Gene Fusion Technology NEW METHODS FOR ENHANCING FUNCTIONAL PROTEIN EXPRESSION AND PURIFICATION IN INSECT CELLS White Paper June 2007 LifeSensors Inc. 271 Great Valley Parkway Malvern, PA 19355 www.lifesensors.com
More informationProtein isotopic enrichment for NMR studies
Protein isotopic enrichment for NMR studies Protein NMR studies ARTGKYVDES sequence structure Structure of protein- ligand, protein-protein complexes Binding of molecules (perturbation mapping) Dynamic
More informationLecture 7: Affinity Chromatography-II
Lecture 7: Affinity Chromatography-II We have studied basics of affinity purification during last lecture. The current lecture is continuation of last lecture and we will cover following: 1. Few specific
More informationBiosimilars Scientific Challenges and Implications
Biosimilars Scientific Challenges and Implications Professor Paul Declerck Laboratory for Therapeutic and Diagnostic Antibodies paul.declerck@pharm.kuleuven.be Biological medicinal product A well-defined
More informationProtein Sources (Heterologous expression of proteins)
Protein Sources (Heterologous expression of proteins) Adrian Suarez Covarrubias Before starting out - why? what? when? where? Recombinant expression? if so, choice of host: prokaryote? eukaryote? modification
More informationRecombinant protein production in Eukaryotic cells. Dr. W. McLaughlin BC35C
Recombinant protein production in Eukaryotic cells Dr. W. McLaughlin BC35C Recombinant protein production in Eukaryotic cells! rhuman protein must be identical to the natural protein! Prokaryotes are generally
More informationThe new innovations of mab biolimilars and antibody therapeutics Our dedication to human health
Prestige The new innovations of mab biolimilars and antibody therapeutics Our dedication to human health New Biosimilar Development A Frontier in Biopharmaceuticals Antibody Therapeutics Development Prestige
More informationTechnical Challenges in the Development of Biosimilars. E. Morrey Atkinson, PhD Interphex May 1, 2012
Technical Challenges in the Development of Biosimilars E. Morrey Atkinson, PhD Interphex May 1, 2012 FDA Guidance on Biosimilarity Guidance for Industry: Scientific Consideration in Demonstrating Biosimilarity
More informationChemically synthesized proteins referencing biological medicinal products
Chemically synthesized proteins referencing biological medicinal products A EuropaBio white paper Calling for: - Equal assessment transparency - Equal measures for traceability and adverse event reporting
More informationAdvanced Microbial Protein Expression
Advanced Microbial Protein Expression Partners for Life Advancing tomorrow s medicines w A Biologics and Vaccines CDMO partner for your complete clinical journey Good science, experience and a quality
More informationThe era of biological medicines
Chapter 1 The era of biological medicines Since their first use in the 1980s, biological medicines (including biosimilar medicines) have grown to become an indispensable tool in modern medicine. Worldwide,
More informationExpression of Next Generation Biologics Requires Next Generation Expression Systems
Expression of Next Generation Biologics Requires Next Generation Expression Systems Joachim Klein, Ph.D., Associate Director, Head of Strain Development and Cell Banking Georg Blaser, Ph.D., Associate
More informationBiologics. Biologics. The Centre for Process Innovation. From innovation to commercialisation
Biologics Biologics The Centre for Process Innovation From innovation to commercialisation The Centre for Process Innovation From innovation to commercialisation The High Value Manufacturing Catapult is
More informationartes white paper Efficient Production of Secreted and Active Invertase artes white paper Manfred Suckow, Volker Jenzelewski, Michael Piontek
Efficient Production of Secreted and Active Invertase Manfred Suckow, Volker Jenzelewski, Michael Piontek ARTES Biotechnology 2017 1 In our today s society, sugar plays an eminent roll. In industrialized
More informationPlant Made Biopharmaceuticals NEXT-GENERATION THERAPEUTICS FOR ORPHAN DISEASES
Plant Made Biopharmaceuticals NEXT-GENERATION THERAPEUTICS FOR ORPHAN DISEASES BryoTechnology: enables delivery of a wide range of products customized according to the individual needs of our clients 02
More informationChemical Biology, WS. Part II: Biology
Chemical Biology, WS Part II: Biology 1 Markus Müller (Dipl. Biologe) Studium 1994-1999 Biologie in Marburg Doktorarbeit (Pflanzenphysiologie) 1999-2003 in Marburg Postdoc 2003-2006 in Umeå, Schweden Seit
More informationChallenges in Manufacturing of Biopharmaceutical. Amulya K Panda National Institute of Immunology New Delhi
Challenges in Manufacturing of Biopharmaceutical Amulya K Panda National Institute of Immunology New Delhi Theatre, Indian Habitat Centre, New Delhi July 30 31, 2013 Outline of talk 1. Bioprocessing of
More informationVELTIS : INNOVATIVE ALBUMIN BASED TECHNOLOGY FOR HALF- LIFE EXTENSION AND OPTIMIZATION OF BIOTHERAPEUTICS
VELTIS : INNOVATIVE ALBUMIN BASED TECHNOLOGY FOR HALF- LIFE EXTENSION AND OPTIMIZATION OF BIOTHERAPEUTICS Dr Mikael Bjerg Caspersen Industrial Biotechnology Conference August 10 th 2015 INNOVATIVE TECHNOLOGY
More informationYour Protein Manufacturer
Expression of Toxic Proteins in E. coli Your Protein Manufacturer Contents 1. Definition of Toxic Protein 2. Mechanisms of Protein Toxicity 3. Percentage of Protein Toxicity 4. Phenotypes of Protein Toxicity
More informationThe era of biological medicines
Chapter 1 The era of biological medicines Since their first use in the 1980s, biological medicines (including biosimilar medicines) have grown to become an indispensable tool in modern medicine. Worldwide,
More informationPlant Made Biopharmaceuticals NEXT-GENERATION THERAPEUTICS FOR ORPHAN DISEASES
Plant Made Biopharmaceuticals NEXT-GENERATION THERAPEUTICS FOR ORPHAN DISEASES PLANT MADE BIOPHARMACEUTICALS: OUR ASSET, YOUR ADVANTAGE We at Greenovation work to advance the development of new treatments
More informationSUMO Technology For Peptides
SUMO Technology For Peptides NOVEL METHODS FOR RAPID RECOMBINANT PEPTIDE EXPRESSION AND PURIFICATION Peptides for Therapeutic, Diagnostics, Vaccines and Industrial Applications cytokinespeptidelibrarieschemokines
More informationPharmaceutical Biotechnology
Pharmaceutical Biotechnology Debbie S. Retnoningrum; Catur Riani; Tri Suciati; Heni Rachmawati; Ana Indrayati School of Pharmacy, ITB Introduction 1 REFERENCES Glick, BR and JJ Pasternak, 2003, Molecular
More informationAssistant Professor Mohammad A Alsenaidy, MSc, PhD, Saudi Arabia
GaBI Scientific Meetings First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars 20 November 2017, Holiday Inn Izdihar Riyadh, Saudi Arabia Assistant
More informationOctober 2018 Investor Presentation
Reinventing Biological Vaccine and Drug Development & Production Dyadic International, Inc. October 2018 Investor Presentation Safe Harbor Regarding Forward-Looking Statements Certain statements contained
More informationCREATING TOMORROW S SOLUTIONS BIOPHARMACEUTICALS I CONTRACT MANUFACTURING WACKER BIOTECH: THE MICROBIAL CMO
CREATING TOMORROW S SOLUTIONS BIOPHARMACEUTICALS I CONTRACT MANUFACTURING WACKER BIOTECH: THE MICROBIAL CMO STATE-OF-THE-ART GMP FACILITIES Our sites in Jena and Halle (Germany) provide a complete range
More informationDemonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product ICH Guidance
Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product ICH Guidance Derek Bradley M.Sc. BioClin Research Laboratories 13 th May 2016 Agenda Brief overview of biosimilars ICH
More informationThe United States Pharmacopeia Strategy on Biotherapeutic Products Standards. Jaap Venema, Ph.D. Chief Science Officer & Chair, Council of Experts
The United States Pharmacopeia Strategy on Biotherapeutic Products Standards Jaap Venema, Ph.D. Chief Science Officer & Chair, Council of Experts U.S. Pharmacopeia Who We Are Scientific, independent, volunteer-driven,
More informationChemical Biology In-class discussion: Tethering
In-class discussion: Tethering This discussion will focus on various Tethering Methods described by workers at Sunesis (for a review, see Erlanson et al. Ann. Rev. Biophys. Biomol. Str. 2004). Regarding
More informationLONG R3IGF-I: An Insulin Alternative Exclusively for Cell Culture Applications
Page 1 of 5 Page 1 of 5 Return to Web Version LONG R3IGF-I: An Insulin Alternative Exclusively for Cell Culture Applications By: Jennifer Fries, BioFiles 2009, 4.5, 14. LONG R 3 IGF-I is a recombinant
More informationCONTRACTING CELL CULTURE
CONTRACTING CELL CULTURE BIOTECH EXPERIENCE Page 2 Professionals in proteins and antibodies Bayer HealthCare has more than 130 years of experience in developing and producing pharmaceuticals. An integral
More informationUnit title: Biotechnology: An Introduction (SCQF level 7)
Higher National Unit specification General information Unit code: H926 34 Superclass: RH Publication date: May 2015 Source: Scottish Qualifications Authority Version: 01 Unit purpose This Unit is designed
More informationChromatography column for therapeutic protein analysis
PRODUCT SPECIFICATIONS ProPac Elite WCX Column Chromatography column for therapeutic protein analysis Benefits Superior resolution power for proteins, monoclonal antibodies, and associated charge variants
More informationModule 1 overview PRESIDENTʼS DAY
1 Module 1 overview lecture lab 1. Introduction to the module 1. Start-up protein eng. 2. Rational protein design 2. Site-directed mutagenesis 3. Fluorescence and sensors 3. DNA amplification PRESIDENTʼS
More informationMass Production of Antithrombin Module. Generate Ideas: In class have the students write journal entries to answer the following questions:
Mass Production of Antithrombin Module Challenge: The human plasma protein antithrombin is an anticoagulant that plays a key role in controlling clot formation. It is used as a therapeutic protein to prevent
More informationClinical Supply Packaging for Biological Products
Clinical Supply Packaging for Biological Products Part 2 of the Clinical Supply Knowledge Share Series: Understanding and Delivering your Global Clinical Supply Chain Almac Clinical Services Clinical Supply
More informationGLOBAL MARKETS FOR BIOENGINEERED PROTEIN DRUGS
GLOBAL MARKETS FOR BIOENGINEERED PROTEIN DRUGS BIO009G January 2017 Shalini Shahani Dewan Project Analyst ISBN: 1-62296-417-9 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215
More informationEffectively utilizing Post Translational Modification analysis to fast track process development for Biosimilars
Effectively utilizing Post Translational Modification analysis to fast track process development for Biosimilars Sanjeev Gupta DGM-Advanced Biotech (R&D) Ipca Laboratories Ltd., Mumbai, India March 04,
More informationIntelligent Disulfide Bond Analysis
Intelligent Disulfide Bond Analysis Why Study Disulfide Bonds? Save Money by making cell cultures more efficient! Regulations Process Control Higher Quality biotherapeutics Efficacy Protect from Competition
More informationBiosimilars China Guideline. Dr Dr Michel Mikhail
Biosimilars China Guideline Dr Dr Michel Mikhail 1 Contents Regulatory context of biologicals in China Decree 28 issued by SFDA October 2007 Proposed biosimilars guideline 10/29/14 Reference drugs to use
More informationPlants for Better Health: Plant Biotechnology in the Generation of New Vaccines and Therapeutics
Plants for Better Health: Plant Biotechnology in the Generation of New Vaccines and Therapeutics Jukka Kervinen, July 16 th 2013 Center for Molecular Biotechnology 1 Many Expression Hosts Are Available
More informationHershey and Chase. The accumulation of evidence: Key Experiments in the Discovery of DNA: Griffith s Transformation Experiment (1928)
Today: Key Experiments in the Discovery of DNA: Griffith s Transformation Experiment (1928) Reviewing Mitosis/ Exploring the Function of Taxol Structure and Function of DNA! What do we learn about the
More informationUnit 2: Metabolism and Survival Sub-Topic (2.7) Genetic Control of Metabolism (2.8) Ethical considerations in the use of microorganisms
Unit 2: Metabolism and Survival Sub-Topic (2.7) Genetic Control of Metabolism (2.8) Ethical considerations in the use of microorganisms Duncanrig Secondary JHM&MHC 2015 Page 1 of 18 On completion of this
More informationChallenges in peptide mapping mass spectrometry of biopharmaceuticals
Challenges in peptide mapping mass spectrometry of biopharmaceuticals Will Burkitt, Ben Holmes, Johanna Paris, Nisha Patel, John O Hara 07.MAR.2018 Characterisation within UCB 2 Context to the type of
More informationINTEGRATED PROTEIN SERVICES
iba INTEGRATED PROTEIN SERVICES Customer-specific protein expression, purification and analysis Please fill out the following and fax to Europe +49 (0) 551-50672-181 US 1-888-531-6813 Or send the scanned
More informationC1, Disrupting Biologic Development & Manufacturing
C1, Disrupting Biologic Development & Manufacturing OTCQX Virtual Investor Conference 2017 October 5, 2017 (OTCQX: DYAI) Safe Harbor Regarding Forward-Looking Statements Certain statements contained in
More informationBi 8 Lecture 5. Ellen Rothenberg 19 January 2016
Bi 8 Lecture 5 MORE ON HOW WE KNOW WHAT WE KNOW and intro to the protein code Ellen Rothenberg 19 January 2016 SIZE AND PURIFICATION BY SYNTHESIS: BASIS OF EARLY SEQUENCING complex mixture of aborted DNA
More informationTake the Rational Approach of the BalanCD CHO Media Platform
Accelerate your development of therapeutics from discovery to commercialization Take the Rational Approach of the BalanCD CHO Media Platform It takes ambition, dedication, and fortitude to translate a
More informationPeptide libraries: applications, design options and considerations. Laura Geuss, PhD May 5, 2015, 2:00-3:00 pm EST
Peptide libraries: applications, design options and considerations Laura Geuss, PhD May 5, 2015, 2:00-3:00 pm EST Overview 1 2 3 4 5 Introduction Peptide library basics Peptide library design considerations
More informationSandoz Biopharmaceuticals. Sandoz Biosimilars. More than a decade of experience
Sandoz Biopharmaceuticals Sandoz Biosimilars More than a decade of experience 2 SANDOZ BIOPHARMACEUTICALS The pioneer and global leader in biosimilars Repeatedly innovating to break new ground 2006 Launched
More informationSOLUBLE PROTEIN EXPRESSION OPTIMIZATION
SOLUBLE PROTEIN EXPRESSION OPTIMIZATION BiologicsCorp www.biologicscorp.com 1 OUTLINE Factors in soluble protein expression optimization Codon optimization Strains Vectors Protein synthesis rate Growth
More informationOBP s MARJORIE SHAPIRO ON ANALYTICAL SIMILARITY IN BIOSIMILAR APPROVAL
OBP s MARJORIE SHAPIRO ON ANALYTICAL SIMILARITY IN BIOSIMILAR APPROVAL In a session on biosimilar regulatory issues at the 2016 PDA/FDA Joint Regulatory Conference in September, Office of Biotechology
More informationBIOCHEMISTRY REVIEW. Overview of Biomolecules. Chapter 13 Protein Synthesis
BIOCHEMISTRY REVIEW Overview of Biomolecules Chapter 13 Protein Synthesis 2 3 4 5 6 7 8 9 10 Are You Getting It?? Which properties are characteristic of the normal genetic code? (multiple answers) a) A
More informationFusion Antibodies. Genes to Proteins to Antibodies
Fusion Antibodies Genes to Proteins to Antibodies Why Fusion Antibodies? 12 years experience of Antibody drug development Milestoned Payments European based limited company High Quality outcomes for the
More informationParadigm Shift in Comparability Assessment:
Paradigm Shift in Comparability Assessment: How Quality by Design (QbD) and Process Analytical Technology (PAT) can improve Structure-Activity Relationship (SAR) evaluation and its relevance to comparability
More informationSHuffle, a novel Escherichia coli protein expression strain capable of correctly folding disulfide bonded proteins in its cytoplasm
Lobstein et al. Microbial Cell Factories 2012, 11:56 RESEARCH Open Access SHuffle, a novel Escherichia coli protein expression strain capable of correctly folding disulfide bonded proteins in its cytoplasm
More informationPfenex Inc. San Diego, CA NYSE MKT: PFNX
Pfenex Inc. San Diego, CA NYSE MKT: PFNX Safe Harbor Statement This presentation (the Presentation ) includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act
More informationWhat next? Manufacture the biosimilar product
What next? Manufacture the biosimilar product Design manufacturing process to match QTPP Full quality dossier required. Use state of the art technologies In accordance with relevant ICH and CHMP guidelines
More informationPharmacist Rana Musa Al-ali (Malkawi) MSc (Pharmaceutical Quality Assurance) Registration Department/JFDA
Pharmacist Rana Musa Al-ali (Malkawi) MSc (Pharmaceutical Quality Assurance) Registration Department/JFDA 1 2 ND MENA Regulatory Conference On Bioequivalence, Biowaivers, Bioanalysis, Dissolution & Biosimilars
More informationDevelop A Highly Similar" Biosimilar Compound: Lessons Learnt
Develop A Highly Similar" Biosimilar Compound: Lessons Learnt Hui-Chun Li, Ph.D. Sr. Manager of Process Science 2015 Feb 05 3rd Biologics World Taiwan 2015 SPIN OFF ACQUISITION Development Center for Biotechnology
More informationUnlock Pichia High level methanol-free phytase production in Pichia pastoris
WHITE PAPER Unlock Pichia High level methanol-free phytase production in Pichia pastoris Thomas Purkarthofer, Evelyn Trummer-Gödl, Iskandar Dib, Roland Weis VTU Technology GmbH, Parkring 18, 8074 Raaba-Grambach,
More informationThe BioPharmaSpec Approach : Mass Spectrometry Based Host Cell Protein Identification and Quantitation
The BioPharmaSpec Approach : Mass Spectrometry Based Host Cell Protein Identification and Quantitation 1. Introduction As part of the development of any biopharmaceutical product, the impurities present
More informationLFB BIOMANUFACTURING YOUR CDMO PARTNER FOR MABS AND RECOMBINANT PROTEINS B IOMANUFACTURING
YOUR CDMO PARTNER FOR MABS AND RECOMBINANT PROTEINS B IOMANUFACTURING COMMITMENT AND FLEXIBILITY LFB BIOMANUFACTURING is a medium-sized CDMO offering Bioproduction services, from an industrial facility
More informationModule I: Introduction
Module I: Introduction 20.109 Lecture 1 3 February, 2011 Introduction to: Module Overview Fundamental concepts and techniques in molecular biology Appreciating nucleic acids (RNA in particular) as more
More informationRegulatory Issues and Drug Product Approval for Biopharmaceuticals
Regulatory Issues and Drug Product Approval for Biopharmaceuticals Vinod P. Shah, Ph. D. FIP Scientific Secretary Biotech 2007 Southern African Regional and International Regulatory Biotechnology Workshop
More informationAnalytical Characterization of Biotherapeutics: Looking to the Future with Biosimilars
Analytical Characterization of Biotherapeutics: Looking to the Future with Biosimilars Jared Auclair, Ph.D. Northeastern University Department of Chemistry and Chemical Biology Barnett Institute of Chemical
More informationIntroduction to Industrial Biotechnology. Lecture 5 Consolidated bioprocessing
Introduction to Industrial Biotechnology Lecture 5 Consolidated bioprocessing Learning outcomes Understand the costs of an cellulosic biofuel plant Appreciate the concept of consolidated bioprocessing.
More informationChapter 8 Lecture Outline. Transcription, Translation, and Bioinformatics
Chapter 8 Lecture Outline Transcription, Translation, and Bioinformatics Replication, Transcription, Translation n Repetitive processes Build polymers of nucleotides or amino acids n All have 3 major steps
More informationDebendra K. Sahoo INSTITUTE OF MICROBIAL TECHNOLOGY CHANDIGARH
Thursday 5 November EU-India PARTNERING EVENT Theme: Life sciences, biotechnology and biochemistry for sustainable non-food products and processes IMTECH Debendra K. Sahoo INSTITUTE OF MICROBIAL TECHNOLOGY
More informationA Hollow Fiber Bioreactor Allows Any Lab to Efficiently Express Recombinant Proteins in Mammalian Cells
A Hollow Fiber Bioreactor Allows Any Lab to Efficiently Express Recombinant Proteins in Mammalian Cells John J S Cadwell, President and CEO, FiberCell Systems Inc. Cultured mammalian cells have become
More informationSynthetic Biology. Sustainable Energy. Therapeutics Industrial Enzymes. Agriculture. Accelerating Discoveries, Expanding Possibilities. Design.
Synthetic Biology Accelerating Discoveries, Expanding Possibilities Sustainable Energy Therapeutics Industrial Enzymes Agriculture Design Build Generate Solutions to Advance Synthetic Biology Research
More informationThe importance of interchangeability in the procurement of medications: Biosimilar case
The importance of interchangeability in the procurement of medications: Biosimilar case ALIMS Congres, Kragujevac, November 6, 2015 Prof. Borut Štrukelj, PhD Brief CV Current position: professor, Pharmaceutical
More informationBest-in-class API / HPAPI / Small Molecules Custom Manufacturing
Best-in-class API / HPAPI / Small Molecules Custom Manufacturing Tippecanoep Ham Hanau Slove enska L upča Dossenh senheim Nanning Production and process development Six production locations countless options.
More informationStability of Biopharmaceuticals: Past, Present and Future. Paul Varley, Vice President, Biopharmaceutical Development
Stability of Biopharmaceuticals: Past, Present and Future Paul Varley, Vice President, Biopharmaceutical Development Agenda 1 The last 20 years or so 2 Where we are now 3 The future 2 Early Process - THEN
More informationDevelopment of high-yielding chemically defined and animal component-free generic processes using GS cell lines. David Mainwaring, Lonza Biologics
Development of high-yielding chemically defined and animal component-free generic processes using GS cell lines. David Mainwaring, Lonza Biologics Introduction Generic processes Process optimisation GS-CHO
More informationSensoLyte 490 MMP-3 Assay Kit *Fluorimetric*
SensoLyte 490 MMP-3 Assay Kit *Fluorimetric* Revision Number:1.1 Last Revised: October 2014 Catalog # Kit Size AS-71130 500 assays (96-well) Convenient Format: All essential assay components are included.
More informationDNA recombination without ligase: TOPO TA Cloning. topoisomerase
DNA recombination without ligase: TOPO TA Cloning topoisomerase Cloning strategies, cloning in bacteria other than E.coli Mitesh Shrestha Cloning strategies Cloning in bacteria other than E.coli Convenient
More informationQuality of biologicals
Quality of biologicals K. Ho Afssaps, France 2011 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2011 ICH 1 Typical biotech manufacturing
More informationXpress CF+ : A Cell-Free Platform for the Rapid Screening and Production of Homogeneous ADCs
Xpress CF+ : A Cell-Free Platform for the Rapid Screening and Production of Homogeneous ADCs Alexander R. Steiner, M.S. Director, Protein Biochemistry Tuesday Feb 3 rd, 215 Making novel drugs is Pammolli
More informationAnalytical similarity: Lessons from the first US biosimilar
Analytical similarity: Lessons from the first US biosimilar 2nd FDA/PQRI Conference on Advancing Product Quality Oct. 5-7, 2015 Corinna Sonderegger, Head Pharmaceutical Development Sandoz Biopharmaceuticals,
More information3.1 Cultivation strategies for secretion and export of native rpa from Escherichia coli
38 3. RESULTS 3.1 Cultivation strategies for secretion and export of native rpa from Escherichia coli 3.1.1 Effect of DsbA co-production and the additive on culture growth and rpa activities Recombinant
More informationMaximizing the Potential of Biomanufacturing Cell Lines
Maximizing the Potential of Biomanufacturing Cell Lines Contents Introduction... 3 CHO cells The key trends... 3 The increasing popularity... 3 The biological context... 4 Batch size/price... 4 Novel antibody
More informationModular DSP approaches for complex non-mab molecules
Modular DSP approaches for complex non-mab molecules Dr. Stefan R. Schmidt MBA SVP Process Science & Production Agenda 1 Introduction 2 3 4 5 Process related impurities Product related impurities Virus
More informationSwitzerland EXPERTS TAKING CARE
CordenPharma Switzerland EXPERTS TAKING CARE CordenPharma Switzerland Eichenweg 1 4410 Liestal Switzerland Phone +41 61 906 59 59 Fax +41 61 906 59 58 sales@cordenpharma.com www.cordenpharma.com Our History
More informationBiology Warm Up. 1. Complete the entrance ticket you received at the door.
Biology Warm Up Monday, February 8 1. Complete the entrance ticket you received at the door. NOTE: This is not a grade. I want to see what you know/remember. Once you finish, place in front blue basket.
More informationIMPORTANCE OF CELL CULTURE MEDIA TO THE BIOPHARMACEUTICAL INDUSTRY
IMPORTANCE OF CELL CULTURE MEDIA TO THE BIOPHARMACEUTICAL INDUSTRY Research, development and production of biopharmaceuticals is growing rapidly, thanks to the increase of novel therapeutics and biosimilar
More informationA primer on the structure and function of genes
A primer on the structure and function of genes What is the definition of a gene? GENE: the genetic element which is transmitted from parent to offspring during the process of reproduction that influences
More informationThe Role of Mass Spectrometry for Developing Biotherapeutics: Regulatory Perspectives
The Role of Mass Spectrometry for Developing Biotherapeutics: Regulatory Perspectives Jun Park, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products CDER/FDA CASSS, Applications of
More informationExecutive Summary. clinical supply services
clinical supply services case study Development and NDA-level validation of quantitative polymerase chain reaction (qpcr) procedure for detection and quantification of residual E.coli genomic DNA Executive
More information