Welcome! CellWorld 2017 San Francisco, CA USA
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1 Welcome! CellWorld 2017 San Francisco, CA USA
2 Intensity Innovation Involvement Integrity
3 Company (Business Unit) Overview Name: Finesse HQ: Santa Clara, CA Founded: 2005 Employees: ~150 Business Description Differentiator Products Business Overview Company Profile Measurement and control solutions for life sciences process applications. Select hardware, software and services for upstream biopharma applications and software and services for downstream applications (downstream hardware in development). Scalable automation solutions for bioprocessing Control systems are platform independent, providing customers with flexibility in purchases Suite of products around controller (SMART) SmartParts: Single-use sensors, lab-scale bioreactors, valves SmartSystems: Universal controllers for lab and production scale SmartMES: Manufacturing Execution System incorporating software SmartFactory: Integration of all components into a seamless network Market Acceptance of Products Original supplier of Single Use (SU) upstream process (USP) Class VI sensors 20,000+ Single Use System (SUS) units shipped since 2008 Growing Installed Base with broad geographic footprint and international sales capabilities: 2,000+ controllers installed in field 1,5000+ lab-scale units 500+ Large Scale SU units (300+ cgmp) Differentiated service solutions provide for recurring revenue streams as installed base expands Downstream (DSP) product pipeline offers significant 1 potential for installed base expansion and additional consumable revenue SmartFactory solutions successfully launched and gaining traction for rapid revenue expansion potential 2016 Revenue Segmentation Geography 12% 3% NA EU 27% 58 % APAC ROW Mix 10% 10% 41% 39% cgmp Labscale SUS/Service 2 Enterprise Notes: 1) Installation services embedded within cgmp, labscale, and SmartFactory; 2) Includes after market electrochemical and OEM single-use sensors (8%) and aftermarket maintenance service contracts (2%)
4 Bio-Process Building Blocks Vision: harmonization Flexible, powerful MES Universal controllers Intelligent components USP TruBio TruChrom TruPur DSP Process Train and Model Assumptions
5 Product Overview SmartParts Intelligent components for modular bioprocess measurement and control SmartSystems Universal hardware with flexible software to enable all scales of UPS and DPS SmartMES / SmartFactory Turn-key SU facility integrating unit operations into a seamless network Sensors Upstream Controllers Manufacturing Execution System 1 Actuators Downstream Controllers SmartFactory Bioreactors Software Alvotech SmartFactory Modular systems with plug-and-play integration, ease of use Fully integrated components reduce costs and enable higher performance Configure-to-order equipment allows shorter lead times, flexibility for future add-ons Allows upstream and downstream processes to be combined with universal controls and flexible software Universal controllers enable customer flexibility across a variety of production platforms and suppliers Continuous processing platform in development Inoculation to drug substance: automation of the entire process Complete solution including data collection, validation and commissioning Electronic batch reports; release by exception Notes: 1) A manufacturing execution system (MES) is a computerized system for managing and monitoring work-in-process on a factory floor.
6 Strategic Rationale: Building On Our Technologies and Workflows Strengthens leadership in efficient bioprocess solutions Expanded commercial reach through Thermo Fisher commercial organization Provides an integrated offering across the workflow from research to production Depth of resources and infrastructure to sustain industry success Enables next generation innovation with superior performance, integrated intelligence and plug-and-play flexibility Enables customers to improve their flexibility, productivity, and insight to their work A complementary portfolio that creates significant value for our customers, employees and shareholders
7 Leading Capabilities for Every Step of the Bioprocess Workflow Upstream Downstream Cell line development and media optimization Mixing, cell culture and fermentation Harvest and collection Purification Bulk storage and final fill Freedom CHO cell lines Process development and media optimization services Shaker flasks and rigid containment Gibco cell culture media, feeds, and enhancers Single-use fermentors, bioreactors and mixers BioProcess containers POROS harvest and separation products QC and analysis Storage and transport Mycoplasma and viral detection POROS chromatography resins CaptureSelect affinity ligands and resins Transfer assemblies Storage and transport BPCs, manifolds and containers Acclimate single-use frozen handling system Production chemicals Sensors Lab-scale Bioreactors Lab-scale Controllers Software (TruBio) insite Integrity Testing System Cell factories Large volume liquids Sensors Controllers Software (TruBio) GMP warehousing, sampling and lot control Sensors US Controllers/Skids Software (TruPur) Host cell DNA, protein and protein A quantitation Large volume liquids DS Controllers/Skids Software (TruChrom) Legend Pump Tower Skids Software Grey text: Legacy BPD capabilities Red text: Finesse expanded capabilities SmartFactory
8 Key Topics End-to-end continuous processing from labscale through manufacturing, with a focus on modular automation, data harmonization and analytics Bio-production for immunotherapy, with a focus on CAR-T platforms, applications of CRISPR/CAS9 and gene editing for personalized medicine SmartFactory - automation platform for mass production of biosimilars in BRIC countries, with minimal footprint and CAPEX requirements
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11 Evolution of Biotech 2017 Vaccines: HepA, HepB, RV5, DTaP, Hib, PCV7, PCV13, HPV, OPV, MMR, VAR, Rabies Live attenuated, inactivated, toxoid, subunit conjugate, recombinant DNA Antibiotics: Anti-tuberculosis, Cell envelope, Combination, Nucleic acid inhibitor, steroid, Thiopepties, stubs, second and third generation Biologicals: recombinant proteins, therapeutic antibodies, virotherapy, adjuvants Therapeutic antibodies: antitoxins, monoclonal/polyclonal, immunoglobulin Recombinant proteins: insulin-based, hormones (FSH, HGH, LTH, filgrastim, etc) 1979 Vaccines: MR, DT, OPV Antibiotics: Penicillin, sulfa, tetracycline Biologicals: none 1978: Recombinant human insulin produced (Genentech, 1 st time) 1979: Human growth hormone (synthesized) 1979: Interferon 1978: first IVF success, not common 1992: First cord blood banking Personalized medicine: CAR-T/CAS9, stem cells, cord blood IVF: 1.6% of live births in US (2016) Cord Blood Banking: choice of 5 national providers
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