Presentation is loading. Please wait.

Presentation is loading. Please wait.

Bioproduction solutions

Similar presentations


Presentation on theme: "Bioproduction solutions"— Presentation transcript:

1 Bioproduction solutions
Date Name Thank you for allowing us this opportunity to provide an overview of Life Technologies bioproduction platform. This presentation will give insight to how our products and services fit within the workflow of our customers.

2 from molecule to market Expression and Production
Setting new standards from molecule to market Introducing bioproduction solutions from Life Technologies bioproduction solutions from molecule to market Cell Therapy Therapeutic Protein Production Microbial Expression and Production Viral Vaccine Production The bio-production platform over the last 4 years has been focused on a molecule to market. As we look toward the future it is our mission to give you more choices and ways to improve your workflow as you move your molecules from early stage indications to Commercial launch. This slide provides an understanding of the various served markets and Life’s expertise in the area of products and services that will optimize the workflow within each market. We have had a long term commitment and a documented track record of supporting Therapeutic Proteins, Microbial Expression and Viral Vaccines. The fourth area of focus is within the Cell Therapy market. During 2010/2011 Life Technologies played a key role in supporting the launch of a prostate cancer treatment. As the Cell Therapy market continue to emerge, you will see various products and workflow initiatives from Life Tech to support the growing demands within this market segment NOTE TO PRESENTER: The appendix contains lists of products and services and links to their online pages. About us Why us? Working with us Products and services Summary

3 from molecule to market Expression and Production
Setting new standards from molecule to market Introducing bioproduction solutions from Life Technologies bioproduction solutions from molecule to market Cell Therapy Therapeutic Protein Production Microbial Expression and Production Viral Vaccine Production NOTE TO PRESENTER: DO NOT DELETE THIS PAGE. This is a hidden page - it is the link to the “home” button from subsequent pages, so the viewer/presenter does not have to go through the animation every time they go “home”. About us Why us? Working with us Products and services Summary

4 PRESENTER IMPORTANT: You have several options on how to show this video.
1. As part of this slide deck This video should play automatically as part of the slide deck if saved in the same folder as the Powerpoint deck. 2. As a stand-alone video separate from this deck From YouTube: go to From your computer: Download the high-res version (75MB) from Documentum at 4

5 Life Technologies is a global biotechnology leader dedicated to making life even better
160+ Countries served $3.6B global leader 1B$ Revenue in Pharma / Biotech space 300M$ Revenue in Diagnostics space 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 As we introduce the BioProduction business it's helpful to understand where the we fit within Life Technologies. Life Technologies view the industry in three segments. The research market, which focuses on PCR and Sequencing and Cell Systems. This is our Research and Discovery segment and represents approx 70% of our business. The commercial applications market is also referred to the regulated market. It includes bioproduction of which we will talk in more detail in later slides…But it also includes applied markets segments like forensics, food testing, animal health, and agriculture/biology. Our forensic team are the market leaders within this business segments working with our the armed forces and the various law enforcement teams around the world. They have been instrumental in supporting crime lab and other security measures on a global level. In the food testing side of the business, we work not only with U.S. based operations, but as an example, we were instrumental in ensuring the safety of the food that was used in the Beijing Olympics. The Applied market represents approx 20-30% of Life Tech Rev. An emerging horizon for us is on the clinical side. This is where we are focused on molecular diagnostics, genomics, and regenerative medicine. The goal here is to support therapeutic application by helping the developer of the drug to better understand the intended patient population. The positive implications is that it would allow the drug to reach its intented market and to reduced the risk of adverse impact on other patient population. We are serving about 160 countries. We're about $3.6 billion in annual sales. We serve about 75,000 customers, 50,000 products. We have about 3,900 patents and the significance of this data is that it demonstrate that we are a science driven company and not just simply a manufacturer of products. LifeTechnologies.com

6 27.2 Bioproduction is leading positive transformation in biologics production Gibco® Cell Culture POROS® Chromatography Applied Biosystems® SEQ Analytics Cellular Medicine Leader in mAb polish chromatography Leader in contaminant and impurity testing New solutions for cell therapy, regenerative medicine Leader in media and feeds for 50 years Bioproduction 24 of the Top 25* pharmaceutical companies worldwide use a LIFE bioproduction solution, many with multi-site adoptions 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*** We are a market leader in this space The Gibco Cell Culture business- celebrating 50 years of success via the support of the both the research and commercial markets. GIBCO is a solutions driven brand. The POROS Chromatography Business is emerging as the leading collaborative supplier in the polished and capture step The Analytics Business - Situated both in the assay development segment to process development and commercial application. The detection systems have been developed to look at both viral contaminants and impurities that are associated with biological manufacturing, both in microbial and also in mammalian cell culture. Cellular medicine. Cell therapy and regenerative medicine are emerging segment markets that is attempting to gain traction and as mentioned earlier, back in 2010 a prostate cancer drug was introduced into the market via cell therapy technologies, and Life Technologies was instrumental doing this, in supporting that in the bioproduction space. Life Tech BioProduction Support 24 of the top 25 biopharmaceutical companies that are in the market. We have a major focus towards Phase I to Phase III development we understand the critical nature of deliverables throughout the process We believe that we are the industry leader in the supporting the commercial manufacture of drugs NOTES FOR PRESENTER: 2010 Top 25 Pharma Pfizer (New York, New York) Novartis (Basel, Switzerland) Sanofi-Aventis (Paris, France) Merck (Whitehouse Station, New Jersey) Roche (Basel, Switzerland) GlaxoSmithKline (Brentford, England) AstraZeneca (London, England) Johnson & Johnson (New Brunswick, New Jersey) Eli Lilly (Indianapolis, Indiana) Abbott (Abbott Park, Illinois) Bristol-Myers Squibb (New York) Teva (Petach Tikva, Israel) Amgen (Thousand Oaks, California) Bayer (Leverkusen, Germany) Takeda (Osaka, Japan) Boehringer Ingelheim (Ingelheim, Germany) Novo Nordisk (Bagsvaerd, Norway) Astellas (Tokyo, Japan) Daiichi Sankyo (Tokyo, Japan) Eisai (Tokyo, Japan) Merck KGaA (Darmstadt, Germany) Gilead Sciences (Foster City, California) Baxter International (Deerfield, Illinois) Mylan (Canonsburg, Pennsylvania) – no LIFE BP solution as of July 2011 Servier (Neuilly-sur-Seine) * Based on list of Top 50 companies from PharmExec 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

7 Bioproduction solutions are used by small to large companies across six continents
Designed for Phase 1-3 process development to large-scale manufacturing The BioProduction Business is clearly globally deployed with a diverse revenue and custom distribution On the left pie chart, you'll see that about 31% of our customers are located in Europe 34% of our customers inside of the U.S. The balance are in Asia-Pacific and Japan. We have a strong interest in serving the emerging markets and we are seeing significant growth within those markets The take home message is we understand that this is a global market and we have a global footprint to support your needs regardless of which markets you decide to serve. On the right hand side of the slide, it gives you a sense of where our revenue is generated by customer segment. As outlined in the pie chart 57% of our business comes from the large bio-pharma 14% of our business comes from mid-biotech/bio-pharma 16% from contract services 11% from Animal Health. A couple of takeaways from this slide as it relates to who we support: We understand that in many cases, technologies and processes will transfer. So a small to mid-biotech company will oftentimes license that technology to a large biopharma. We want our customers to be comfortable that we have a presence almost anywhere around the world and that we can support that interest regardless of whether it's in an emerging market or in some of the more established markets Revenue, by Geography Revenue, by Customer Segment

8 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 We understand the dynamics and the urgency of markets trends Vaccine- both at a potential pandemic response and or a work flow improvement from egg based production to cell culture we serve as a key collaborative supporter within this market. Biosimilars- As certain key drugs are coming off patent interest in the introduction of biosimilars clearly is an emerging business trend….where both the companies who own the patent and those who are seeking to enter the market are putting together their mutual game plan…We have coordinated effort in working with companies around that arena. Cell & Media- we understand product quality, a cell line stability, and/or short-term or long-term demands that are needed within that market. Because we work throughout the continuum of both pre-clinical all the way through critical Phase III trials, we sensitive to the critical needs and the impact on the supply chain. Product safety- whether raw material qualification and or the detection and or removal of contaminants that could work its way into a particular platform… We are geared both on the raw material screening side, on the finished goods side using our Purification- whether if is managing a specific step in the process and or dealing with increase titers

9 Innovations transform bioproduction today
GMP cells Friendly IP Highest resolution + capacity Impurity testing in < 5 hours Freedom™ CHO Cell Lines Simplified commercial cell line development with optimized workflows and unprecedented IP access Three Areas of INNOATION CHO Cell line. We recognized when it came down to customers use of particular cell systems, that there were market constraints at both the development and transition to commercial manufacture of their therapeutic. Our objective was to address that need by the introduction of the Cho Kit. This is a cGMP certified cell line that allows customers the freedom to operate from preclinical to launch of the therapeutic. POROS XS- is formulated address increase titer, higher concentration of NaCl and broader pH ramge within the downstream purification polishing step It has experienced one of the fastest adoption rates of any resin that we have introduced to the market so far. In the last year and a half we have been adopted in a number of phase three clinical trials, Residual DNA – using our realtime QPCR technology with focus on Host Cell and Protein A DNA detection. The objective is to provide our Customers with the most creditable set of data within the shortest turnaround time. NOTE TO PRESENTER: These are examples of how Bioproduction is setting new standards in how biologics are produced today. Buttons are hyperlinked to the product lists for each of the businesses. <Note: swap in the imagery or ad for a particular product or service to customize the slide to the needs of the audience.> POROS® XS Chromatography Resin High Resolution + High Capacity = Improved Yield resDNASEQ® Host Cell DNA Quantitation System Same-day results using integrated sample prep, reagents, instruments, and software Gibco® Cell Culture POROS® Chromatography Applied Biosystems® SEQ Analytics Cellular Medicine

10 Working with us Bioproduction Online Community You
LIFE Bioproduction homepage Gibco Media Configurator for web quoting, order tracking Webinars and educational events Mobile applications You 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® cGMP Media Custom Services Account Representative How do we interact with our customer base. We us a Business to Business approach, connecting Process Science Fellows with our Customer Process Development team Our Planners and PMO team with our Customer’s Supply Chain managers and Planners Sr Executive Projects that are managed and updated via QBRs to insure our mutual ongoing support 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

11 Bioproduction Manufacturing Sites
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 Auckland, New Zealand Sera and protein products manufacturing Newcastle, Australia Sera manufacturing Singapore Sequencing and PCR instrument manufacturing Austin, TX, United States Pharma analytics kit manufacturing Paisley, Scotland Cell culture media and reagents Christchurch, New Zealand Protein products manufacturing Bedford, MA, United States Chromatography resins manufacturing Warrington, England

12 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 that set new industry standards Product quality Product safety Fast-to-market efficiency Dedicated Program Management Office bioproduction solutions from molecule to market

13 Redefining bioproduction tomorrow
Today Functional feeds Segment-specific products and services (vaccines, biosimilars, CMOs, cell therapy) Omics-based profiling Affinity, IEX and custom chromatography Protein PCR Bioburden surveillance Objectionable organism panels Environmental monitoring programs Next generation sequencing applications Closed automated platform for cell isolation GMP cell line kits Media and feeds Sera and reagents Contaminant and impurity assays Chromatography resins Services Take a molecular leap into the future with Bioproduction – your partner of choice today and into tomorrow.

14 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 Getting from molecule to market occurs through six major steps. Clearly every customer is different. We want to show a general overview here to lay the foundation for the next slides which go through these steps in the context of the kind of therapeutic being produced. 5 4 Commercial scale-up and launch Clinical manufacturing 14 14

15 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 kits Gibco® PD-Direct cell line development services POROS® analytical columns MycoSEQ™ Mycoplasma Detection System ViralSEQ® Virus Detection Assays (MMV, Vesivirus) MicroSEQ® Microbial Identification System Gibco® media and feeds Custom cell culture media Gibco® PD-Direct media development and analytical services POROS® analytical columns GoPure™ disposable columns ViralSEQ® Virus Detection Assays (MMV, Vesivirus, PCV1/PCV2) POROS® polish and capture chromatography resins GoPure™ disposable columns resDNASEQ® Host Cell DNA Quantitation Assays (CHO,NS0) ProteinSEQ™ Quantitation Assay (Protein A, HCP) MicroSEQ® Microbial Identification System for bacteria and fungi Freedom™ CHO-S™ cell line kit Gibco® media and feeds POROS® Chromatography Resins MicroSEQ™ Microbial Identification System

16 Identification System
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 MicroSEQ® Microbial Identification System Custom media in different formats POROS® chromatography resins resDNASEQ® Host Cell DNA Quantitation Assays (e. coli, Pichia) GoPure™ disposable columns MicroSEQ® Microbial Identification System for bacteria and fungi POROS® analytical columns resDNASEQ® Host Cell DNA Quantitation Assays MicroSEQ® Microbial Identification System

17 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 Gibco® media development and analytical services resDNASEQ® Host Cell DNA Quantitation Assays ViralSEQ® Virus Detection Assays MicroSEQ® Microbial Identification System ViralSEQ® Virus Detection Assays (MMV, Vesivirus) Gibco® PD-Direct media development and analytical services MicroSEQ® Microbial Identification System Gibco® media Custom media in different formats GoPure™ disposable columns ViralSEQ® Virus Detection Assays (MMV, Vesivirus) Gibco® PD-Direct media development and analytical services MicroSEQ® Microbial Identification System POROS® chromatography resins resDNASEQ® Host Cell DNA Quantitation Assays (Vero, MDCK) MicroSEQ® Microbial Identification System for bacteria and fungi

18 Molecule-to-market solutions supporting cell therapy
NEEDS Integrated automated platforms Efficient cell analytics Custom solutions High quality growth BIOPRODUCTION SOLUTIONS MycoSEQ™ Mycoplasma Detection System MicroSEQ® Microbial Identification System Dynabeads® lgG1 Binder CTS DynaMag™ CTS magnet Cell therapy and stem cell services MicroSEQ® Microbial Identification System Dynabeads® CD3/CD28 CTS Media, growth factors, buffers and supplements Cell therapy and stem cell services MicroSEQ® Microbial Identification System for bacteria and fungi MycoSEQ™ Mycoplasma DetectionSystem Cell therapy and stem cell services Dynabeads® immunotherapy products

19 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.

20 Appendix

21 Gibco® products and services
Media & feeds Cells CD CHO* CD OptiCHO™* CD FortiCHO™* CHO CD EfficientFeed™ A CHO CD EfficientFeed™ B* CD EfficientFeed™ C AGT Custom media in different formats (AGT, DPM, liquid, concentrate) *Also available in proprietary Advanced Granulation Technology™ (AGT™) format Freedom™ Cell Line Development Kits CHO-S™ CHO-DG 44 Licensing Sera Reagents & disposables Bioproduction services Fetal bovine sera Horse sera Rabit sera rHu Insulin AOF Buffers TryPLE™ Reagents FoamAway™ anti-foaming agents Gibco® disposable bags Gibco® Process Development Team 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® cGMP Media Custom Services “Great all around selection of products, great customer service.” Customer survey, 2011

22 POROS® products and services
Bulk resins Analytical columns Disposable columns XS 50 µm Bulk Resin MabCapture™ 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 R1 50 µm Bulk Resin R2 50 µm Bulk Resin 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™ S 20 µm Columns, PEEK™ MC 20 µm Columns, PEEK™ HP 20 µm Columns, PEEK™ R1 20 µm Columns, PEEK™ R2 20 µm Columns, PEEK™ GoPure™ 1.2 cm Diameter Column GoPure™ 8.0 cm Diameter Column GoPure™ 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

23 Applied Biosystems® SEQ products and services
Product safety microbiological contaminant analysis Product quality biologics impurity analysis Microbial Identification System MicroSEQ® Rapid Sample Prep PrepMan® Ultra Sample Prep. Reagent Kits MicroSEQ® S rDNA Bacterial Identification Kit MicroSEQ® Full Gene 16S rDNA Bacterial Identification Kit MicroSEQ® D2 LSU rDNA Fungal Identification Kit Instruments Veriti® 96-Well Thermal Cycler 3500 Genetic Analyzer Software MicroSEQ® iD Analysis Software Services Validation and Implementation Services Mycoplasma Detection MycoSEQ™ Mycoplasma Detection Assay Host Cell Residual DNA Quantitation resDNASEQ® Quantitative DNA System (CHO, NS0, E. coli, Pichia, MDCK, Vero) Virus Detection ViralSEQ® Vesivirus Detection Assay ViralSEQ® MMV Detection Assay Protein Detection ProteinSEQ™ Protein Quantitation Assay Sample Preparation PrepSEQ® Mycoplasma Sample Preparation Kit plus Module M PrepSEQ® Nucleic Acid Extraction Kit 7500 Fast Real-Time PCR System Automate Express™ Nucleic Acid Extraction System AccuSEQ® Real-Time PCR Detection Software Implementation and Training Services “Applied Biosystems® gives the most consistent results, and they have the best technical support for their products” Customer survey, 2011

24 Cellular medicine products and services
Immunotherapy products Stem cell media and reagents AIM V® Medium CTS™ OpTmizer™ CTS™ T-Cell Expansion SFM Dynabeads® CD3⁄CD28 CTS™ DynaMag™ CTS™ Cell Therapy Systems DPBS CTS™ (without Ca and Mg) Recombinant human growth factors Cell therapy and stem cell services KnockOut™ CTS™ Media CELLstart™ CTS™ Reagents DPBS CTS™ Reagents (with Ca and Mg) TrypLE™ Select CTS™ Reagents GlutaMAX™-I CTS™ Reagents

25 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


Download ppt "Bioproduction solutions"

Similar presentations


Ads by Google