Optimization Strategies of Expression Cell Line Construction to Reduce the Biological Drug Development Risk. Feng Gao, MD, PhD. AutekBio CO.
|
|
- Bruce Wheeler
- 6 years ago
- Views:
Transcription
1 Optimization Strategies of Expression Cell Line Construction to Reduce the Biological Drug Development Risk Feng Gao, MD, PhD AutekBio CO.
2 Expression Systems used for Approved Antibody and Antibody-Related Drug CHO Mouse Myeloma (Sp2/0, NS0) Hybridoma E. Coli ~ 72% well characterized continuous cell line- rodent origin 50% CHO/ 50% mouse myeloma ~ 19% hydridoma ~ 8% bacterial Drug Information Association 2
3 Phase Length of FDA Approved Products Drug Information Association 3
4 Monoclonal Antibody New Drug Development & Production Process Progression MAb Selection Initial Tests GLP Study IND Phase I/II Phase III NDA Commercial Production mg 1-10g 10-50g g kilograms Requirements Research R&D GMP FDA cgmp FDA inspected cgmp, no process change Equipments Normal Lab <50L <250L Bioreactor Bioreactor <1000L Bioreactor 3,000-20,000L Bioreactor, multiple lines Cell Line Generation (CLG) Process Development & Scaling-up GMP Production
5 Current Improvement in Cell Development Transient expression in bioreactor Provide gram level products at early stage Higher titer and yield Good enough cell line and process in short time Faster development timeline Shorten timeline to clinical trial Single-used bioreactor Increase flexibility of DS and DP production Drug Information Association 5
6 Different Strategies to Speed-up Drug Development Timeline IND NDA CLG & PD Pre-clinical Studies Phase I & II Clinical Trial Phase III Clinical Trial On Market Typical Approach Cell Line Generation (5-12M) Process Development (>12M) grams Scale-up (10M) grams Scale-up (12M) grams Scale-up years Cur. Approach International Preliminary CLG & Process Development (12M) grams Scale-up (10M) grams Cell Line Generation & Process Development (12M) grams Scale-up years Available Approach International Large-scale transient expression (3-6M) grams Preliminary CLG & PD (12M) grams Cell Line Generation & Process Development (12M) grams Scale-up years Drug Information Association 6
7 Selection of Candidate IND Pre-clinical Study Phase I/II Phase III NDA Cell Development and DS Production GMP DP Manufacturing GMP DP Manufacturing Scale-up PD for Market Production Selection of Candidate IND Pre-clinical Study Phase I/II Phase III NDA Good Cell Development and DS Production Good Cell Production Final Manufacturing Cell Development and GMP DP Manufacturing Scale-up PD for Market Production Selection of Candidate IND Pre-clinical Study Phase I/II Phase III NDA Transient DS Production Good Cell Development and DS Production Final Cell Development & GMP DP Manufacturing Scale-up PD for Market Production Drug Information Association 7
8 What is available in China and how can we implement the new technologies in drug development? Drug Information Association 8
9 Using Transient Expression for Material Production in Early Stage Protein Production Using Transient Methods Time 7-10 days; Host cells CHO, HEK 293 Medium Serum free, ACF MAb 1 ~500 mg/l Other low expression recombinant protein Up to 20 mg/l Drug Information Association 9
10 Large-scale Transient Expression Gram level mab production in short time Good for candidate screening and selection Preliminary PK/PD study Toxicity prediction Drug Information Association 10
11 Sample data: Delivered Good Cell Lines for mab Production Drug Information Association 11
12 Good Cell Line and Process for Material Preparation Tens of grams production starts in 6 months after good cell line generation and good process development Ready for preliminary animal studies Products close to final target protein drug Ready for formulation study Ready for analytical method development Drug Information Association 12
13 Process development, DOE strategy Simplex Lattice Design to Optimize Basal Medium Drug Information Association 13
14 Process development, DOE strategy continued Response Surface Design to Optimize Feed Supplement Drug Information Association 14
15 Process development, DOE strategy continued Drug Information Association 15
16 In-depth Studies for Final Manufacturing Cell Line and Process MCB ready Scalable process ready Half Kg production Ready for pre-clinical study Drug Information Association 16
17 Scaling-Up Using Single-Use Bioreactor 50L S.U.B. 250L S.U.B. Drug Information Association 17
18 Single-used Bioreactor To save space and initial investment Gives flexibility on process development and material production Short turn-around time for multiple products Drug Information Association 18
19 Fully integrated DSP capability scales from mg to kg Drug Information Association 19
20 Summary New technologies provide more options for drug development strategy To choose different strategy Different application system and different application approaches The characteristics of the target protein The availability of analytical technology Cost and timeline Drug Information Association 20
Introduction of Development Center for Biotechnology TAIWAN
Introduction of Development Center for Biotechnology TAIWAN DCB Nonprofit Organization Founded in 1984 Funded Mainly by Ministry of Economic Affairs (MOEA), National Science Council and the Industry 394
More informationCHO-GSN PLATFORM STABLE CELL LINE GENERATION. NR v5
CHO-GSN PLATFORM STABLE CELL LINE GENERATION NR3160 20180122 v5 Highlights of LakePharma s CHO-GSN Cell Line Platform 2 LakePharma proprietary technology Complete cell line lineage and clear path to commercialization,
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 informationBalanCD HEK293 SYSTEM
BalanCD HEK293 SYSTEM Maximize productivity in suspension cultures Versatile formulation supports transfection and production including: - Rapid, scalable production of viral vectors - Use the same system
More informationBalanCD HEK293 SYSTEM
BalanCD HEK293 SYSTEM Maximize productivity in suspension cultures Versatile formulation supports transfection and production including: - Rapid, scalable production of viral vectors - Use the same system
More informationManufacturing Integrated Biologics Manufacturing
Manufacturing Integrated Biologics Manufacturing Integrated Biologics Manufacturing Abzena provides customer focused process development and manufacturing services for cgmp and non-gmp production of recombinant
More informationChallenges 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 informationBD Resurge Media Supplements Chemically Defined. Protein Free. Animal Free.
D Resurge Media Supplements Chemically Defined. Protein Free. nimal Free. Overview Cell-based production of active pharmaceutical ingredients generally requires supplementation of cell culture media to
More informationUpstream mammalian cell processing challenges and prospects
BioProcess International Berlin, April 11-14, 2005 Upstream mammalian cell processing challenges and prospects John Birch Lonza Significance of Mammalian Cell Processes Commercial significance of biopharmaceutical
More informationRecombinant Antibody Production in Therapeutic Antibody Projects. Keshav Vasanthavada Senior Marketing Specialist, GenScript April 7, 2016
Recombinant Antibody Production in Therapeutic Antibody Projects Keshav Vasanthavada Senior Marketing Specialist, GenScript April 7, 2016 Presentation Outline 1 2 3 4 5 Introduction Recombinant Ab Production
More informationA Regulator s Perspective on Risk Based and Phase Appropriate Comparability. Marjorie Shapiro, Ph.D. Division of Monoclonal Antibodies OBP, CDER,FDA
A Regulator s Perspective on Risk Based and Phase Appropriate Comparability Marjorie Shapiro, Ph.D. Division of Monoclonal Antibodies OBP, CDER,FDA WCBP 2014 Outline Reasons for Changes Comparability ICH
More informationRisk Assessments for Host Cell Protein Control Strategies: CDER Experiences
Risk Assessments for Host Cell Protein Control Strategies: CDER Experiences Laurie Graham FDA/CDER Office of Pharmaceutical Quality (OPQ) Office of Policy for Pharmaceutical Quality (OPPQ) 1 Disclaimer
More informationFrom gene to manufacturing: Application of efficient cell line development strategies to deliver reliable, high quality biomanufacturing processes
From gene to manufacturing: Application of efficient cell line development strategies to deliver reliable, high quality biomanufacturing processes Dr Alison Porter, FUJIFILM Diosynth Biotechnologies, UK
More informationOverview Rentschler Biotechnologie
Overview Rentschler Biotechnologie AusBiotech, Adelaide, 18.10.2011 Klaus B. Schoepe, PhD, SVP Client Relations - 1 - Our Mission As an independent leading, internationally operating service company, we
More informationEfficient Project Management of Outsourced Biopharmaceutical Development and Manufacturing Programs
Efficient Project Management of Outsourced Biopharmaceutical Development and Manufacturing Programs Thomas C. Ransohoff and Howard L. Levine, Ph.D. BioProcess Technology Consultants Inc. Presented at IBC
More informationClinical Trials A Closer Look
The Food and Drug Administration (FDA) is the main consumer watchdog for numerous products: Drugs and biologics (prescription and over-the counter) Food Medical devices Animal feed and drugs Cosmetics
More informationDrug-Device Combination Product Development: INDs for Device Companies
Drug-Device Combination Product Development: INDs for Device Companies David Armbruster Global Program Manager April 24, 2013 Drug-Device Combination Product Development -or- The scenic route to an IND
More informationFast Trak Services from molecule to market
GE Healthcare Fast Trak Services from molecule to market OPEN At the speed of Fast Trak Whether you re looking to launch a new molecule, enhance existing capacity, or bring biosimilars to emerging markets,
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 informationGenetic Characterization of Production Cell Lines
Genetic Characterization of Production Cell Lines Luhong He and Christopher Frye 2017 CMC Strategy Forum Outlines Overview Genetic characterization strategy and case studies Transgene characterization
More informationPerformance by Design: Engineering Functionality into Biopharmaceutical Products
Performance by Design: Engineering Functionality into Biopharmaceutical Products Susan Dana Jones, Ph.D. Cambridge Healthtech Institute Peptalk Overcoming Expression Challenges Session San Diego, CA January
More informationCell Line Characterization and Product Testing for CHO-Derived Biopharmaceutical Products
Cell Line Characterization and Product Testing for CHO-Derived Biopharmaceutical Products Founded in 96, Eurofins Lancaster Laboratories is a global leader in comprehensive laboratory services enabling
More informationFujifilm Diosynth Biotechnologies. General Introduction
Fujifilm Diosynth Biotechnologies General Introduction October 2016 Value from Innovation Safety information Accompanied by FDB staff at all times Fire alarm. Follow host to assembly point Toxic alarm.
More informationThermo Scientific Metabolic Pathway Design Process Cell culture media and process optimization approaches for optimal biotherapeutic production
Thermo Scientific Metabolic Pathway Design Process Cell culture media and process optimization approaches for optimal biotherapeutic production May/June 2013 1 The world leader in serving science Agenda
More informationFrom Bench to Bedside. Russ H. Read June 23, 2014
From Bench to Bedside Russ H. Read June 23, 2014 Talent Required Scientists, clinicians, technicians, chemists, biologists, pharmacologists, toxicologists, research associates, regulatory experts, manufacturing
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 informationApplication of ICH Q12 Tools and Enablers Post-Approval Lifecycle Management Protocols
Joint BWP/QWP/GMDP IWG Industry European Workshop on Lifecycle Management Application of ICH Q12 Tools and Enablers Post-Approval Lifecycle Management Protocols 1 Outline Introduction: evolution of PACMP
More informationRECENT IMPROVEMENTS TO LONZA S GLUTAMINE SYNTHETASE (GS) GENE EXPRESSION SYSTEM. Dr Robert Gay
RECENT IMPROVEMENTS TO LONZA S GLUTAMINE SYNTHETASE (GS) GENE EXPRESSION SYSTEM Dr Robert Gay Lonza Biologics plc, 2004 The Challenge of the MAb Market Global market for Monoclonal Antibody Therapeutics
More informationAPPROACHES TO IMPROVING THE PERFORMANCE OF MAMMALIAN CELL CULTURES FOR PROTEIN PRODUCTION
BioLOGIC USA BOSTON, 20 th OCTOBER 2004 APPROACHES TO IMPROVING THE PERFORMANCE OF MAMMALIAN CELL CULTURES FOR PROTEIN PRODUCTION Dr Robert Gay Lonza Biologics 2004 The Challenge of the MAb Market Global
More informationBiosimilar Monoclonal Antibodies: Registration Requirements. Henry M. J. Leng
Biosimilar Monoclonal Antibodies: Registration Requirements Henry M. J. Leng Disclaimer This presentation is given in my personal capacity and represents only the author s personal views and does not represent
More informationHollow Fiber Bioreactors: Single-Use. Perfusion. Scalable. Continuous Manufacturing.
Bioreactors and BioServices for the Life of your Proteins Hollow Fiber Bioreactors: Single-Use. Perfusion. Scalable. Continuous Manufacturing. Presented by: Scott Waniger Vice President, BioServices BPI
More informationPreclinical Development Drugs. Darrin Cowley PhD Executive Director Amgen BioBoot Camp 2015
Preclinical Development Drugs Darrin Cowley PhD Executive Director Amgen BioBoot Camp 2015 Product Development: Development process: File Approval Drug Discovery Preclinical Phase 1 Phase 2 Phase 3 Lifecycle
More informationPrioritizing and Managing Key CMC Elements
Prioritizing and Managing Key CMC Elements Using 21 st Century Principles during Early Development Laurie Graham Product Quality/CMC Reviewer FDA/CDER/OPS/OBP Division of Monoclonal Antibodies 1 Disclaimer
More informationOutline. Upstream Processing: Development & Optimization
Upstream Processing: Development & Optimization Kamal Rashid, Ph.D., Director Biomanufacturing Education & Training Center Worcester Polytechnic Institute Outline Introduction to Upstream processing Microbial
More informationSCIENTIFIC. Process for Success. CHO ONE Media System. Expression Media for Fed-Batch Culture
CAPRICORN SCIENTIFIC Process for Success CHO ONE Media System Expression Media for Fed-Batch Culture Culture for Life www.capricorn-scientific.com 2 Capricorn Scientific as a young established cell culture
More informationStrategic Considerations for Manufacturing Process Development
Strategic Considerations for Manufacturing Process Development PDA Israel Key areas for strategic drug development planning Ramat Gan, 24th Oct 2018 Oren Hesrhkovitz GM, Opko Biologics Presentation Overview
More informationThe Elite Provider. Cell & Gene. Therapy Manufacturing
The Elite Provider Cell & Gene Therapy Manufacturing GMP Manufacturing Services The cgmp manufacturing in Vigene is compliant with US FDA and EU EMA regulatory requirements. The manufacturing area consists
More informationIn recent years, there has been
From Discovery to the Clinic A Robust Strategy for Rapid Development of Clinical Manufacturing Processes Michael J. Gramer,, Mark D. Hirschel, and Jae Sly In recent years, there has been a rapid increase
More informationDMTC Technology Readiness Levels Guideline
Technology Readiness Levels Technology Readiness Levels (TRLs) are used as standardised numerical indicators of the level of maturity of a technology. The standard TRL definitions are given in Table 1.
More informationPRAXIS. A publication by Bioengineering AG
PRAXIS A publication by Bioengineering AG Portrait of Rentschler Biotechnologie GmbH, a globally active service company that supports its clients in the development, production, and registration of biopharmaceuticals.
More informationSpeed your time to market with FDA s expedited programs
Regulatory Sciences Expediting drug approval Speed your time to market with FDA s expedited programs The faster way to marketing submission and drug approval for serious conditions and rare diseases In
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 informationReform of Biological Products Review with a Focus on CMC
Reform of Biological Products Review with a Focus on CMC Office of Pharmaceutical Science of Biological Products Center for Drug Evaluation (CDE) of CFDA Min Li WCBP, Jan 2018 Outline Background of Drug
More informationGala s Gene Product Expression (GPEx ) Platform
Gala Biotech A Company with Gene Insertion and Manufacturing Technologies for the Next Generation of Gene Expression and Biologics Production Gala s Gene Product Expression (GPEx ) Platform Rapid creation
More informationThe Braine BioPilot An Integral Part of Bioprocess Development for Cell Culture- Based Biologics
The Braine BioPilot An Integral Part of Bioprocess Development for Cell Culture- Based Biologics Visit of Alabama Biotech Oct 2014 Alain BERNARD Vice President GPS, UCB Technical Operations Tech Ops BioTech
More informationDrug Development Services
Drug Development Services Speaker Introduction Nik Burlew Vice President Regulatory and Strategic Development 25 Years in Pharma: Development, MFG and QA. Consulting for the last 13 years primarily to
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 informationIdentification of Critical Product Quality Attributes: Impact of Product Variants on Safety and Efficacy
Identification of Critical Product Quality Attributes: Impact of Product Variants on Safety and Efficacy Ziping Wei, Ph.D. Analytical Biochemistry MedImmune January 25, 2010 Outline Why do we need to identify
More informationDr. Earl Dye CMC/GMP Considerations for Expedited Development Programs
Dr. Earl Dye CMC/GMP Considerations for Expedited Development Programs Earl Dye is Director of Technical Regulatory Policy in Genentech s Washington, DC Regulatory Affairs Office, and is the FDA Liaison
More informationEarly Development Best Practices for Stability- Regulatory Perspective
Early Development Best Practices for Stability- Regulatory Perspective IQ Workshop, Feb. 4-5, 2014, Washington, D.C. Ramesh Sood, Ph.D. Division Director (Acting) Office of New Drug Quality Assessment
More informationProteoGenix. Life Sciences Services and Products. From gene to biotherapeutics Target Validation to Lead optimisation
ProteoGenix Life Sciences Services and Products From gene to biotherapeutics Target Validation to Lead optimisation ProteoGenix Philippe FUNFROCK, founder and CEO French company located in Strasbourg,
More informationPotelligent CHOK1SV. How It Works. Potelligent CHOK1SV
Potelligent CHOK1SV Potelligent CHOK1SV Potelligent CHOK1SV How It Works A new host cell line for the production of recombinant antibodies has been developed through close collaboration between Lonza and
More informationConverting rabbit hybridoma into recombinant antibodies with effective transient production in an optimized human expression system
Converting rabbit hybridoma into recombinant antibodies with effective transient production in an optimized human expression system Dr. Tim Welsink Molecular Biology Transient Gene Expression OUTLINE Short
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 informationRequest for Quote RFQ #
Request for Quote RFQ # 2017-007 Drug Product Manufacture: GMP Fill/Finish of Monoclonal Antibody I. Summary of Deadlines Release of Request for quote Feb 13, 2017 Confirmation of interest due by Feb 20,
More informationRapid selection of high yielding GS-CHO cell lines using the GS expression system in a protein-free, chemically defined, animal component-free process
Rapid selection of high yielding GS-CHO cell lines using the GS expression system in a protein-free, chemically defined, animal component-free process David Mainwaring, Lonza Biologics. Introduction Chemically
More informationNational Institute of Immunology, New Delhi
National Institute of Immunology, New Delhi QUOTATION INVITATION NOTICE For Website Ref: NII/AKS/GPL/2013 Date: 25/12/2013 Quotations are invited from technical firms specializing in either both or one
More informationRegulatory Considerations on. Office of Biotechnology Products
Regulatory Considerations on Multiproduct t Facilities for Biotechnology Products Jun Park, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products OPS/CDER/FDA 2011 CASSS CMC Strategy
More informationBD Select CHO. Novel, high yield CHO media that stands out from the crowd.
BD Select CHO Novel, high yield CHO media that stands out from the crowd. Catalog No: 220253 Advantages of using BD Select CHO Breakthrough production yield, achieved through proprietary optimization
More informationHUMAN CHALLENGE TESTING
HUMAN CHALLENGE TESTING CLINICAL RESEARCH SOLUTIONS DE-RISKING Faced with increasing pressures on timelines and budgets, clinical research practices need to continuously evolve in order to ensure pipeline
More informationINTEGRATED PRODUCTION PLATFORMS
FRAUNHOFER INSTITUTE FOR MOLECULAR BIOLOGY AND APPLIED ECOLOGY IME PROCESS DEVELOPMENT, SCALE UP, GMP-COMPLIANT PRODUCTION AND CONSULTING INTEGRATED PRODUCTION PLATFORMS EVERYTHING STARTS WITH YOUR BRILLIANT
More informationRegulatory perspective on setting clinically relevant specifications. Joslyn Brunelle, PhD Team Leader Office of Biotechnology Products
Regulatory perspective on setting clinically relevant specifications Joslyn Brunelle, PhD Team Leader Office of Biotechnology Products Disclaimer The views and opinions expressed should not be used in
More informationTable of Contents. Presented by
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 May 2017 TABLE OF CONTENTS
More informationExploratory IND: a study proposal from Novartis
Exploratory IND: a study proposal from Novartis Rossella Belleli ECD BIOS Novartis 17 Nov 005 Presentation outline What is an exploratory (exp)ind compared to a traditional IND Introduction to traditional
More informationToxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development
Toxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development No. 1 of 10 1. regulates all the drugs products manufactured and sold in the USA. (A) EMEA (B) IND (C) FDA (D) NDA (E) OSHA
More informationForesee Pharmaceuticals, Inc.
Foresee Pharmaceuticals, Inc. Rapid Development and Commercialization of a Proprietary Sustained-release Depot Formulation of Leuprolide for the Treatment of Advanced Prostate Cancer PNWBIO Meeting 10
More informationRecent Developments & Future Directions in the Production of Monoclonal Antibodies. Rob Noel Plasma Product Biotechnology Conference 2009, Menorca
Recent Developments & Future Directions in the Production of Monoclonal Antibodies Rob Noel Plasma Product Biotechnology Conference 2009, Menorca Forecast sales by molecule type ($m), 2006 12 600,000 Pharmaceuticals
More informationCopyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited.
Statutory Framework for Biologics Drugs Investigational Use Application IND Pre-Market Approval Applications 505(b)(1) NDA 505(b)(2) NDA 505(j) ANDA Over-the-Counter (OTC) Non- Rx Drugs Monograph Biologics
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 informationA FDA Product Reviewer s Perspective on Building A Quality Dossier
A FDA Product Reviewer s Perspective on Building A Quality Dossier CASSS Mid-West Discussion Group October 29, 2015 University Center of Lake County, Grayslake, IL Howard Anderson, PhD Team Lead Product
More informationEuropean Guideline for Virus Safety Evaluation of Clinical Trial Material
Plasma Product Biotechnology Meeting, May 8 12, 2007 European Guideline for Virus Safety Evaluation of Clinical Trial Material Dr. Hannelore Willkommen Vice President Regulatory Affairs, NewLab Bioquality
More informationImpurities in Drugs: Monitoring, Safety and Regulation The Israel Chapter of PDA
Overview of exploratory INDs Impurities in Drugs: Monitoring, Safety and Regulation The Israel Chapter of PDA July, 15 16, 2008 David Jacobson-Kram, Ph.D. DABT Office of New Drugs Center for Drug Evaluation
More informationMammalian Expression Platform
Mammalian Expression Platform Partners for Life Advancing tomorrow s medicines w Your CDMO partner for biologics and advanced therapies Good science, experience and a quality driven approach Line/Strain
More informationAccelerated Path to Probe Biology through Deferred Cloning and Applying Platform Manufacturing Processes
Accelerated Path to Probe Biology through Deferred Cloning and Applying Platform Manufacturing Processes Rohini Deshpande, Ph.D., Executive Director Drug Substance Development, Amgen Thousand Oaks, CA
More informationKFDA Regulatory Framework on Biopharmaceuticals - Focus on Biosimilar
KFDA Regulatory Framework on Biopharmaceuticals - Focus on Biosimilar Kyung-Min Baek, Ph.D. Recombinant Protein Products Division Korea Food and Drug Administration(KFDA) Biopharmaceuticals A biopharmaceutical
More informationFDA recommendations for comparability studies to support manufacturing changes. Joslyn Brunelle, PhD Office of Biotechnology Products OPQ/CDER/FDA
FDA recommendations for comparability studies to support manufacturing changes Joslyn Brunelle, PhD Office of Biotechnology Products OPQ/CDER/FDA The views and opinions expressed here should not be used
More informationRE: Draft Annex 2: Manufacture of Biological Medicinal Products for Human Use
1201 Maryland Avenue SW, Suite 900, Washington, DC 20024 202-962-9200, www.bio.org 14 March 2008 European Commission Enterprise and Industry Directorate-General B-1049 Brussels Belgium BY EMAIL TO entr-gmp@ec.ec.europa.eu
More informationBiotechpharma company profile. Romanas Ramanauskas Business development manager
Biotechpharma company profile Romanas Ramanauskas Business manager October, 2012 1 Contents History Company overview Services and capabilities Expression system and process Technology scale-up and GMP
More informationOpportunities for Accelerating Cell Line Development and Beyond
Opportunities for Accelerating Cell Line Development and Beyond European CM&C Strategy Forum May 24, 2017 Christopher Frye, Ph.D. Research Advisor & Group Leader Bioprocess R&D Presentation Outline CM&C
More informationSPEED UP YOUR TIME TO MARKET
SPEED UP YOUR TIME TO MARKET #Pre-clinical #Biologics #Small molecules Welcome to Accelera. As a Contract Research Organization (CRO) serving since more than 30 years pharmaceutical and biotechnology companies
More information1. Clinical Program Manager (ideally based in greater Boston, MA, USA area)
Livzon Mabpharm, Inc ( 珠海丽珠单抗生物技术有限公司 ) a development stage biotech company, was jointly founded by two publically traded companies (Livzon Pharmaceuticals Group and JointCare). It focuses on the development,
More informationBioWhittaker Specialty Media Maximize Your Cell Growth and Productivity
BioResearch BioWhittaker Specialty Media Maximize Your Cell Growth and Productivity BioWhittaker Specialty Media Cell Culture Applications BioResearch BioWhittaker Specialty Media Maximize Your Cell Growth
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 informationClonePix 2. Screen and select more clones in less time. Genetix Now part of Molecular Devices.
ClonePix 2 Screen and select more clones in less time www.moleculardevices.com/genetix Genetix Now part of Molecular Devices Screen more clones in less time Cut cell line and antibody development times
More informationFDA s Role in Vaccine Supply
IOM Committee on Review of Priorities of the National Vaccine Plan Stakeholder Workshop #1 24 July 2008 FDA s Role in Vaccine Supply Norman W. Baylor, Ph.D., Director Office of Vaccines Research and Review
More informationCharacterization of Biotechnology Products: A Regulatory Perspective
Characterization of Biotechnology Products: A Regulatory Perspective Laurie Graham Acting Team Leader FDA/CDER/OPS/OBP Division of Monoclonal Antibodies WCBP 2013 1 Disclaimer The views and opinions expressed
More informationThe use of GMO Technology at Pfizer Ireland. Neysi Ibarra, PhD Senior Manager, Process Development
The use of GMO Technology at Pfizer Ireland Neysi Ibarra, PhD Senior Manager, Process Development Presentation Outline The use of cell culture in the biotechnology industry The complexity of (recombinant)
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 informationPRIME-XV T CELL CDM. Chemically-defined, animal component-free medium for T cell culture
T CELL CDM Chemically-defined, animal component-free medium for T cell culture Chemically-defined, animal component-free formula delivers optimal performance Optimized to support vigorous growth while
More informationBIOLOGICS DEVELOPMENT From Discovery to Manufacturing
BIOLOGICS DEVELOPMENT From Discovery to Manufacturing About LakePharma LakePharma is the leading US-based biologics company specializing in antibody and protein, engineering, cell line development and
More informationPharma&Biotech. Developability Assessment Platform Reduce Attrition Rates, Improve Clinical Safety and Avoid the Valley of Death
Pharma&Biotech Developability Assessment Platform Reduce Attrition Rates, Improve Clinical Safety and Avoid the Valley of Death The Valley of Death Development risk, safety and high attrition rates remain
More informationSartorius Stedim Cellca. Custom Cell Line & Process Development for Pharmaceutical Purposes
Sartorius Stedim Cellca Custom Cell Line & Process Development for Pharmaceutical Purposes May 2017 Overview of Contents 1 2 3 Cellca History Overview: Cellca Technology Platform Products & Services 4
More informationGPhA Fall Technical Conference Nov 2-5, 2015 Bethesda, MD ICH M7 Guidance Overview and Current FDA Perspectives
GPhA Fall Technical Conference Nov 2-5, 2015 Bethesda, MD ICH M7 Guidance Overview and Current FDA Perspectives Stephen Miller, Ph.D. CMC-Lead; Office of New Drug Products Office of Pharmaceutical Quality
More informationFast Trak Services: a collaborative project to accelerate downstream biosimilar process development
GE Healthcare Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development A case study Case study, 2924332 AA Fast Trak Services A collaborative project to accelerate
More informationDSM Biologics. DSM Brings Mammalian cgmp Manufacturing to Australia
DSM Biologics AusBioTech 2012 Melbourne October 31, 2012 Marc Goemans VP Global Marketing & Sales DSM Brings Mammalian cgmp Manufacturing to Australia Agenda Introduction Brisbane How do we serve Australian
More informationPRELIMINARY AGENDA ** Attendees must already be registered to attend cphi Japan conference**
PRELIMINARY AGENDA ** Attendees must already be registered to attend cphi Japan conference** The Future of Biologics Development and Manufacturing 20 April 2017 13:00 16:00 Big Sight Exhibition Center,
More informationAUTOMATED HIGH THROUGHPUT CELL LINE GENERATION
AUTOMATED HIGH THROUGHPUT CELL LINE GENERATION TABLE OF CONTENTS 3 4 6 8 10 11 ClonaCell EasyPick Platform Hamilton Robotics The Advantage of ClonaCell Media Automated High Throughput Colony Isolation
More informationFrom Discovery to Development of new Drugs. and pitfalls along the way. by Kim Dekermendjian, PhD in Medicine BD & Key Account manager
From Discovery to Development of new Drugs. and pitfalls along the way by Kim Dekermendjian, PhD in Medicine BD & Key Account manager The roots of Drug Discovery Before 20 th century the term didn't exists,
More informationDouble digit-titers and high product quality of Nanobodies
Double digit-titers and high product quality of Nanobodies Manu De Groeve, PhD Scientist CMC-USP Process Development Pichia 2014 conference March 2 5, 2014 San Diego CA, USA Nanobodies - Inspired by nature
More informationClare Simpson 21 st November Content courtesy of Steve Jones, Paul Illot, Bert Frohlich, Thomas Ryll Biopharm Services
Modelling a technology roadmap for acceleration of global industry innovation Presentation to Wales Life Science Hub, Health Economics Special Interest Group Clare Simpson 21 st November 2016 Content courtesy
More information