Bioproduction solutions Date Name
Setting new standards from molecule to market Introducing bioproduction solutions from Life Technologies bioproduction solutions from molecule to market Therapeutic Protein Production About us Why us? Cell Therapy Viral Microbial Vaccine Expression and Production Working with us 2 Products and services Summary 3/19/2018 | Life Technologies™
4 3/19/2018 | Life Technologies™
Life Technologies is a global biotechnology leader dedicated to making life even better • • • 160+ Countries served $3. 6 B global leader 1 B$ Revenue in Pharma / Biotech space 300 M$ Revenue in Diagnostics space 75000+ customers 50, 000 + products 3, 900+ patents and licenses 10, 000 employees >1, 000 New Product Introductions per year Industry recognition as a life science leader Life. Technologies. com 5 3/19/2018 | Life Technologies™
Bioproduction is leading positive transformation in biologics production Bioproduction • 24 of the Top 25* pharmaceutical companies worldwide use a LIFE bioproduction solution, many with multi-site adoptions Gibco® Cell Culture Chromatography POROS® Leader in media and feeds for 50 years Leader in m. Ab polish chromatography Applied Biosystems® SEQ Analytics Leader in contaminant and impurity testing Cellular Medicine New solutions for cell therapy, regenerative medicine • A majority of future biotherapeutics currently in Phase 1 -3 development use a LIFE bioproduction solution** • A large number of launched biotherapeutics today are manufactured using a LIFE bioproduction solution*** * Based on list of Top 50 companies from Pharm. Exec 50, Pharmaceutical Executive Magazine, May 2011 ** Based on analysis using the Pharmaprojects Database - Pharmaceutical Research & Development Pipeline Intelligence, © Informa UK Ltd ***Based on analysis of list of Top 200 Pharmaceutical Products, The Njardarson Group, Cornell University 6 3/19/2018 | Life Technologies™
Bioproduction solutions are used by small to large companies across six continents Bioproduction solutions Designed for Phase 1 -3 process development to large-scale manufacturing Revenue, by Geography Revenue, by Customer Segment 7 3/19/2018 | Life Technologies™
Solutions respond to urgent industry trends Vaccines Shift from egg-based to cell culture-based Biosimilars More drugs coming off patent, need for shorter time to end-user Cells, Media Standardization of cell lines, demand for shorter timelines, final product quality, higher titers Product safety Heightened concerns and risk of contamination Purification bottlenecks Need to support faster scale-up and manufacturing Cell therapy Need for complete workflow solutions Ease of use Major shift to disposables in upstream/downstream, automation for analytics 8 3/19/2018 | Life Technologies™
Innovations transform bioproduction today Highest resolution + capacity GMP cells Friendly IP Freedom™ CHO Cell Lines Simplified commercial cell line development with optimized workflows and unprecedented IP access Gibco® Cell Culture Impurity testing in < 5 hours POROS® XS Chromatography Resin High Resolution + High Capacity = Improved Yield POROS® Chromatography res. DNASEQ® Host Cell DNA Quantitation System Same-day results using integrated sample prep, reagents, instruments, and software Applied Biosystems® SEQ Analytics 9 Cellular Medicine 3/19/2018 | Life Technologies™
Working with us Bioproduction Online Community You • LIFE Bioproduction homepage • Gibco Media Configurator for web quoting, order tracking • Webinars and educational events • Mobile applications Gibco® Bioproduction Services • Gibco® Process Development Team • Scientific and business development support • Gibco® Program Management Office • Singlepoint of contact for order management and execution • Gibco® PD-Direct Services - Cell line development services - Media development and analytical services • Gibco® Media Express • Gibco® c. GMP Media Custom Services Account Representative Technical Support and Services • • On-site technical support POROS® Customs Services SEQ Validation and Implementation Services Cell therapy and stem cell services Global Support 10 3/19/2018 | Life Technologies™
Worldwide distribution, service and support reach 150 countries on 6 continents Bioproduction Manufacturing Sites Grand Island, NY, United States Cell culture media, reagents, and sera manufacturing Paisley, Scotland Cell culture media and reagents manufacturing Auckland, New Zealand Sera and protein products manufacturing Christchurch, New Zealand Protein products manufacturing Newcastle, Australia Sera manufacturing Bedford, MA, United States Chromatography resins manufacturing Singapore Sequencing and PCR instrument manufacturing Warrington, England Pharma analytics kit manufacturing Austin, TX, United States Pharma analytics kit manufacturing 11 3/19/2018 | Life Technologies™
Take a molecular leap into the future. Let us take you from molecule to market, so you can take the world from today to tomorrow. Meet new challenges • • • Escalating demand for biotherapeutics and vaccines New cell lines Heightened concerns about product safety Emerging biosimilars Personalized medicine across multiple therapy classes • • • Therapeutic protein production Microbial expression and production Viral vaccines production Regenerative medicine Immunotherapy using trusted brands • • Gibco® cell culture POROS® chromatography resins Applied Biosystems® SEQ analytics Cellular medicine solutions bioproduction solutions from molecule to market that set new industry standards • • Product quality Product safety Fast-to-market efficiency Dedicated Program Management Office 12 3/19/2018 | Life Technologies™
Redefining bioproduction tomorrow Today • Functional feeds • Media and feeds • Sera and reagents • Contaminant and impurity assays • Protein PCR • Segment-specific products and services (vaccines, biosimilars, CMOs, cell therapy) • GMP cell line kits • Bioburden surveillance • Omics-based profiling • Chromatography resins • Services • Affinity, IEX and custom chromatography 13 • Objectionable organism panels • Environmental monitoring programs • Next generation sequencing applications • Closed automated platform for cell isolation 3/19/2018 | Life Technologies™
Your partner from molecule to market Focus on both the journey and the destination 2 • Media optimization • Process optimization Upstream, downstream and analytical solutions for every stage of the journey 1 • Cell line development • Expression development 6 Global manufacturing 3 • Cell expansion • Fermentation • Viral expansion 5 4 Clinical manufacturing 14 14 Commercial scale-up and launch 3/19/2018 | Life Technologies™
Molecule-to-market solutions supporting mammalian therapeutic protein production NEEDS • GMP CHO cell lines • Reproducible high titer • Rapid assays for key contaminants and impurities • Chemically defined, AOF media and matched feeds • High capacity, high resolution, salt-tolerant resins for polish chromatography BIOPRODUCTION SOLUTIONS • Freedom™ CHO cell line • Gibco® media and feeds • POROS® polish and • Micro. SEQ® Microbial kits capture chromatography Identification System for • Custom cell culture media resins bacteria and fungi • Gibco® PD-Direct cell line • Gibco® PD-Direct media development services • Go. Pure™ disposable development and analytical columns • POROS® analytical columns services • res. DNASEQ® Host Cell DNA Freedom™ Mycoplasma Gibco® media and feeds Micro. SEQ™ Microbial • Myco. SEQ™ CHO-S™ • POROS® analytical columns POROS® Chromatography Quantitation Assays cell line kit Resins Identification System Detection System • Go. Pure™ disposable columns (CHO, NS 0) • Viral. SEQ® Virus Detection • Myco. SEQ™ Mycoplasma Detection • Micro. SEQ® Microbial Assays (MMV, Vesivirus) System Identification System • Micro. SEQ® Microbial • Viral. SEQ® Virus Detection Assays • Protein. SEQ™ Quantitation Identification System (MMV, Vesivirus, PCV 1/PCV 2) Assay (Protein A, HCP) • Micro. SEQ® Microbial Identification System 15 3/19/2018 | Life Technologies™
Molecule-to-market solutions supporting microbial expression and production NEEDS • Host cell lines • Chemically defined media and vectors • Validated and automated rapid contaminant and impurity tests • High capacity, high resolution, salt-tolerant resins for polish chromatography BIOPRODUCTION SOLUTIONS • POROS® analytical columns • Micro. SEQ® Microbial Identification System • Custom media in different • POROS® chromatography resins • Micro. SEQ® Microbial formats Identification System for • res. DNASEQ® Host Cell DNA bacteria and fungi • POROS® analytical columns Quantitation Assays (e. coli, Pichia) • Micro. SEQ® Microbial Identification System • Go. Pure™ Cell POROS® analytical res. DNASEQ® Host disposable columns Micro. SEQ® Microbial columns DNA Quantitation Assays Identification System • Micro. SEQ® Microbial Identification System 16 3/19/2018 | Life Technologies™
Molecule-to-market solutions supporting viral vaccine production NEEDS • Integrated platform for top human and veterinary vaccine host cells • High cell density, virus titer, and virus stability BIOPRODUCTION SOLUTIONS • Viral. SEQ® Virus Detection Assays (MMV, Vesivirus) • Gibco® PD-Direct media development and analytical services Gibco® media development • and analytical services Micro. SEQ® Microbial Identification System • POROS® chromatography resins • Micro. SEQ® Microbial Identification System for Custom media in different formats • res. DNASEQ® Host Cell DNA bacteria and fungi Quantitation Assays (Vero, MDCK) Go. Pure™ disposable columns • Go. Pure™ disposable columns Viral. SEQ® Virus Detection Assays (MMV, Vesivirus) • Micro. SEQ® Microbial Viral. SEQ® Virus res. DNASEQ® Host Cell DNA Identification System Micro. SEQ® Microbial • Gibco® PD-Direct media Detection Assays Quantitation Assays Identification System development and analytical services • Micro. SEQ® Microbial Identification System • • Gibco® media 17 3/19/2018 | Life Technologies™
Molecule-to-market solutions supporting cell therapy NEEDS • Integrated automated platforms • Efficient cell analytics • Custom solutions • High quality growth BIOPRODUCTION SOLUTIONS • Myco. SEQ™ Mycoplasma Detection System • Micro. SEQ® Microbial Identification System Myco. SEQ™ Mycoplasma Detection. System • Dynabeads® lg. G 1 Binder CTS • Myco. SEQ™ Mycoplasma Detection System • Dyna. Mag™ CTS magnet • Dynabeads® CD 3/CD 28 CTS • Micro. SEQ® Microbial • Myco. SEQ™ Mycoplasma Identification System for Detection System bacteria and fungi • Cell therapy and stem cell services Dynabeads® Cell Myco. SEQ™ Mycoplasma • Micro. SEQ® Microbial Identification therapy and immunotherapy products stem cell services Detection. System • Media, growth factors, buffers and supplements 18 • Cell therapy and stem cell services • Micro. SEQ® Microbial Identification System 3/19/2018 | Life Technologies™
Legal Disclosure Life Technologies manufactures products labeled for Research Use Only, and for In-Vitro Diagnostic use. Please refer to the Life Technologies website for specific indications and use information for these products. © 2011 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. 19 3/19/2018 | Life Technologies™
Appendix 20 3/19/2018 | Life Technologies™
Gibco® products and services Media & feeds Cells • • Freedom™ Cell Line Development Kits CD CHO* CD Opti. CHO™* CD Forti. CHO™* CHO CD Efficient. Feed™ A CHO CD Efficient. Feed™ B* CD Efficient. Feed™ C AGT Custom media in different formats (AGT, DPM, liquid, concentrate) - CHO-S™ - CHO-DG 44 • Licensing *Also available in proprietary Advanced Granulation Technology™ (AGT™) format Sera Reagents & disposables Bioproduction services • Fetal bovine sera • Horse sera • Rabit sera • • • Gibco® Process Development Team r. Hu Insulin AOF Buffers Try. PLE™ Reagents Foam. Away™ anti-foaming agents Gibco® disposable bags • Scientific and business development • Gibco® Program Management Office • Order execution and management • Gibco® PD-Direct Services • Cell line development services • Media development and analytical services • Gibco® Media Express • Gibco® c. GMP Media Custom Services “Great all around selection of products, great customer service. ” Customer survey, 2011 21 3/19/2018 | Life Technologies™
POROS® products and services Bulk resins • • • XS 50 µm Bulk Resin Mab. Capture™ A Resin Heparin 50 µm Bulk Resin HQ 50 µm Bulk Resin HS 50 µm Bulk Resin D 50 µm Bulk Resin PI 50 µm Bulk Resin R 1 50 µm Bulk Resin R 2 50 µm Bulk Resin Analytical columns • • • Protein A 20 µm Columns, PEEK™ Protein G 20 µm Columns, PEEK™ AL 20 µm Columns, PEEK™ EP 20 µm Columns, PEEK™ OH 20 µm Columns, PEEK™ PI 20 µm Columns, PEEK™ HS 20 µm Columns, PEEK™ MC 20 µm Columns, PEEK™ HP 20 µm Columns, PEEK™ R 1 20 µm Columns, PEEK™ R 2 20 µm Columns, PEEK™ Disposable columns • Go. Pure™ 1. 2 cm Diameter Column • Go. Pure™ 8. 0 cm Diameter Column • Go. Pure™ 20 cm Diameter Column Services • Custom Services “Their resins can be used at higher flow rates with very good protein binding capacity. ” Customer survey, 2011 22 3/19/2018 | Life Technologies™
Applied Biosystems® SEQ products and services Product safety microbiological contaminant analysis Microbial Identification System • Micro. SEQ® Rapid Sample Prep • Prep. Man® Ultra Sample Prep. Reagent Kits • Micro. SEQ® 500 16 S r. DNA Bacterial Identification Kit • Micro. SEQ® Full Gene 16 S r. DNA Bacterial Identification Kit • Micro. SEQ® D 2 LSU r. DNA Fungal Identification Kit Product quality biologics impurity analysis Instruments • Veriti® 96 -Well Thermal Cycler • 3500 Genetic Analyzer Software • Micro. SEQ® i. D Analysis Software Services • Validation and Implementation Services Mycoplasma Detection • Myco. SEQ™ Mycoplasma Detection Assay Host Cell Residual DNA Quantitation • res. DNASEQ® Quantitative DNA System (CHO, NS 0, E. coli, Pichia, MDCK, Vero) Virus Detection • Viral. SEQ® Vesivirus Detection Assay • Viral. SEQ® MMV Detection Assay Protein Detection • Protein. SEQ™ Protein Quantitation Assay Sample Preparation • Prep. SEQ® Mycoplasma Sample Preparation Kit plus Module M • Prep. SEQ® 1 -2 -3 Nucleic Acid Extraction Kit Instruments • 7500 Fast Real-Time PCR System • Automate Express™ Nucleic Acid Extraction System Software • Accu. SEQ® Real-Time PCR Detection Software Services • Implementation and Training Services “Applied Biosystems® gives the most consistent results, and they have the best technical support for their products” Customer survey, 2011 23 3/19/2018 | Life Technologies™
Cellular medicine products and services Immunotherapy products Stem cell media and reagents • • • AIM V® Medium CTS™ Op. Tmizer™ CTS™ T-Cell Expansion SFM Dynabeads® CD 3⁄CD 28 CTS™ Dyna. Mag™ CTS™ Cell Therapy Systems DPBS CTS™ (without Ca and Mg) • Recombinant human growth factors • Cell therapy and stem cell services 24 Knock. Out™ CTS™ Media CELLstart™ CTS™ Reagents DPBS CTS™ Reagents (with Ca and Mg) Tryp. LE™ Select CTS™ Reagents Gluta. MAX™-I CTS™ Reagents Recombinant human growth factors Cell therapy and stem cell services 3/19/2018 | Life Technologies™
Core strengths align with customer needs Best-in-class technology Global technical & sales support Customer satisfaction State-of-the-art operations “They go all the way to cut red tape and deliver what you need today and not tomorrow. “ “You can trust this company. ” Customer survey, 2011 25 3/19/2018 | Life Technologies™
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