BPD SUT Capabilities. Revision date: July The world leader in serving science

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1 BPD SUT Capabilities Revision date: July 2016 The world leader in serving science

2 We Are The World Leader in Serving Science Global Scale 50,000 employees in 50 countries $17 billion in annual revenues Unparalleled commercial reach Unmatched Depth Leading innovative technologies Applications expertise Lab productivity partner Premier Brands 2

3 Our Business Segments Mass Spectrometry Q-Exactive HF mass spectrometer Clinical Diagnostics Analytical Instruments Chromatography Vanquish Ultra HPLC Chemical and Environmental Analysis Gemini handheld analyzer Specialty Diagnostics ImmunoDiagnostics ImmunoCAP Allergy and Asthma Tests Microbiology 19% 19% $17B Revenue 37% 25% Life Science Solutions Clinical Oncology Next Gen Sequencing Genetic Sciences Human Identification QuantStudio Dx R qpcr GlobalFiler PCR Amplification Kit Laboratory Products and Services Lab Equipment Sorvall WX+ Ultracentrifuge Biosciences Life Science Reagents BioProduction Single-use Systems Distribution and BioPharma Services Oral-Eze Oral Fluid Collection System Pathology Antimicrobial Susceptibility Testing Solutions Rotary Microtome Transplant Diagnostics NXType High Resolution Genotyping Chemicals Enterprise and Instrument Services Lab Consumables E1 ClipTip Pipette system 3

4 A Mission We re Proud of We enable our customers to make the world healthier, cleaner and safer. 4

5 BioPharma Industry Challenges Right the First Time. Every Time. Quality Maintaining cgmp Compliance Improving Productivity BioPharma Industry Continuity of Supply Supply Chain Transparency Reduction of Costs Mitigation of Risk Accelerating Discovery A Growing and Changing Biotherapeutics Market 5

6 Best-in-class solutions for up- and downstream bioprocessing UPSTREAM DOWNSTREAM Cell Line Development & Media Optimization Mixing, Cell Culture & Fermentation Harvest & Collection Purification Bulk Storage & Final Fill QC & Analytics Freedom CHO cell lines BioProcess Containers (BPC) BioProcess Containers (BPC) BioProcess Containers (BPC) BPCs, manifolds, containers Analytical services Single-use mixers, bioreactors and fermentors Harvest and separation products Single-use mixing systems Storage and transport Media optimization services Transfer assemblies Single-use heat exchanger Transfer assemblies Single-use filling system Gibco Media Express Inflation and integrity test system Single-use aseptic sampling system Frozen Handling system Mycoplasma and viral detection Microbial identification and Glycan analytics Analytical columns Sample prep and automation 6

7 Drive Your Supply Chain Confidence Key initiatives Business Continuity Safety Stock Demand Planning Redundancy of manufacturing for key cell culture and singleuse products Plans for effective prevention and recovery from operational disruption All sites Environmental, Health & Safety (EHS) compliant Maintenance of intermediate and finished good safety stocks Product can be shipped from our warehouses within 2 days of your request for single-use Approximately 5 million liters of finished goods stored each month for cell culture Help eliminate lead times by aligning Thermo Fisher s production schedule to yours Some products can be available 4 weeks prior to your target date Assurance of Supply To have your supplies when you need them 7

8 Global BioProduction Manufacturing Facilities Indicates a SUT facility Cramlington, UK Bioprocess containers Class 10,000/ISO 7 clean room Paisley, Scotland Cell culture media, reagents ISO GMP 21 CFR 820 Logan, Utah Bioprocess containers Single-use technologies Class 10,000/ISO 7 clean room Warrington, UK Analytics kits Grand Island, NY Cell culture media, reagents Sera ISO GMP 21 CFR 820 Naarden, The Netherlands ISO9001 certified Affinity ligands Matamoros, Mexico BioProcess Containers ISO FDA Registered Millersburg, PA BioProcess Containers Single-use technologies ISO FDA Registered Bedford, MA Chromatography resins ISO Auckland and Christchurch, New Zealand Newcastle, Australia Sera Protein products GMP 21 CFR 820 8

9 The Power of ONE Brand Company Name Premier Product Brand Product Line Identifiers HyPerforma (for legacy Thermo Fisher hardware) impulse, DHX, Acclimate, insite, Precise (for former ASI hardware) Aegis5-14, CX 5-14, ASI 26/77, ASI 28 (for film platforms) Product Names Single-Use Mixers DS 300 Single-Use Bioreactors Single-Use Fermentors Drums Single-Use Mixers Heat Exchanger Frozen Handling System Integrity Testing System Single-Use Filling System Labtainer Productainer Powdertainer Harvestainer Rock-It Transfer Assemblies Manifolds Services 9

10 The Power of the Thermo Scientific Brand Benefits to our single-use customers Portfolio Options & Diversity Assurance of Supply Improved Productivity Innovation A complete portfolio of best-in-class hardware including mixers, fermentors, bioreactors, heat exchangers, point-of-use integrity testers and filling systems. Expansive film and BioProcess Container (BPC) options to deliver optimal film and configurations based on performance, chemical and biological properties Opportunity to partner as qualified primary and secondary supplier through separate legal entities with global manufacturing facilities Provide manufacturing redundancy in each of its bioprocess facilities for all films More choices add more flexibility to customer s manufacturing capabilities Meet customer demand for both quality and productivity in bioprocessing A continuous pipeline of innovative solutions and capabilities across our wide range of products and applications. Continued investments to sustain our best-in-class products with customers evolving requirements. 10

11 Single-use Technology (SUT) 11

12 Films Film material: CX5-14, Aegis 5-14, ASI 26/77, ASI 28 Sizes: 50 ml to 5,000 L Surface Area/Volume ratio: Small bags -High SA/V, Large Bags - Low SA/V Fluid compositions: Media, Buffers, Excipients, Intermediates, Drug products Fluid Residency Times: Temperatures: Short term to Long term -80 C to +60 C 12

13 Film Excellence - The Reason why Customers Choose Us Our BioProcess Containers are specifically designed for single-use bioprocessing and meet stringent quality standards. Due to the film strength, robustness and flexibility, our BPC are suitable for use in upstream, for cell culture and fermentation, or downstream, for sophisticated applications or simply as holding and transfer systems in cgmp bioprocessing facilities. Benefits: Outstanding physical characteristics for superior puncture resistance and content integrity Coextruded structure to minimize delamination potential Greater cleanliness and low leachable/ extractable profiles Non animal origin formulations for safer contact surfaces High gas- and liquid-barrier properties for better content stability Validation packages assurance of product performance Sizes ranging from 50mL 5,000L 13

14 BPC Standard and Custom Designs Chambers 2 D 3 D Manifolds Specialty Powdertainer Harvestainer Storage and Transport Drums Bins Docking Systems Integrated S.U.M. S.U.B. S.U.F. DHX Smartainer Applications Media hydration Cell Culture Harvest Freeze / Thaw Buffer Prep Open architecture approach for component customization 14

15 Leading Supplier of 2D & 3D BPC Manufacturing >1.5 million BPC chambers annually Standard and custom configurations in as little as 4 weeks Powder and liquid handling, incl. liquid shipping Largest standard component library to Shorten lead times Provide choice and flexibility Support highest quality standards Multiple manufacturing sites on two continents 97% on-time and in full product delivery Quality documentation and validation guides available BioProcess Containers L Labtainer 50 ml-50 L Complex Manifolds L >20 years developing SUT products specifically for the biopharma industry 15

16 Most Widely Used 3D BPC for SUT in the Industry Standard and custom configurations for upstream and downstream applications Open architecture approach (filters, sensors, connectors etc.) Single-film qualification from 30 L 5000 L for hardware BPC Multiple manufacturing sites on two continents Single-Use Mixers L Zero lead time and stocking products available to guarantee assurance of supply Optional Point-of-Use Integrity Testing System for any BPC available Multiple film options for single-use hardware systems Single-Use Bioreactors & Fermentors L >20 years developing SUT products specifically for the biopharma industry 16

17 Your Partner in Single-use Fluid Transfer Assemblies Your complete end-to-end solution provider Your trusted guide for single-use technology and applications Fastest industry lead times* A single point of coordination for design, manufacturing and service Helps reduce your burden of required equipment and upkeep Helps free your personnel for other crucial activities Fluid transfer assemblies are customized to your existing processes Designs accommodate a variety of components using our open architecture approach and draw from our qualified standard components library, the industry s largest Delivering the benefits of single-use technology** 3 week lead times for sterilized products 17

18 Single-use Bioreactors 18

19 Single-use Bioreactor BPC Single-use connectors Port labeling on bags and cables Pressure sensor Probe belt for classical & single-use sensors Open pipe sparger Frit sparger Optional sample manifold Open pipe sparger Drill hole sparger 19

20 Two S.U.B. Family Offerings Open Architecture Thermo Scientific S.U.B. Integrate with the control platform of your choice Scalability from 25 to 2000L Turnkey Solutions Thermo Scientific HyPerforma S.U.B. TK State-of-the-art S.U.B. with integrated control choices from two suppliers Choice of leading controller platforms for Turnkey S.U.B. 20

21 Single-use Process Analytical Technologies (PAT) Technologies available today: Pressure ph DO Technologies emerging: CO 2 Cell Mass Metabolites Cutting-edge Technologies 21

22 Single-use Mixing Technologies Thermo Scientific HyPerforma Single-use Mixers (S.U.M.s) Thermo Scientific impulse Single-use Mixers (S.U.M.s) 22

23 Available Mixing Platforms impulse Core impulse Elite impulse MDS SUM DS 300 Mixtainer Description Mixer-Simple Control Mixer-High Control Mixer-Dock-Ship Mixer-Simple Control Mixer-Dock Mixer-Dock-Ship Size Range (L) 30 10,000L 30 10,000L 30, ,000L L 50, 100, 200 Linear Scalability Yes Yes Yes Yes Yes Yes Tank Temperature Control No Jacket Heat No Jacket Heat No No Bag Auto Inflation and Automatic Vent Control No Yes No No No No Sensors No ph, DO, CO 2, Temp, Weight, Conductivity, Fluid Height No ph, DO, Temp, Weight, Pressure Base Mobility Fixed/Casters Fixed/Casters Fixed/Casters Fixed/Casters Casters Casters Mixing Technology Btm-imPULSE Btm-imPULSE Btm-imPULSE Top Stir Tank Top Stir Tank Btm-Stir Bar Controls Self sustained e-box e-box e-box, PLC, PC, Delta V No No e-box Handheld controls Power, Speed Minimum Mixing Volume 1% 1% 1% 20% 20% 1% Drain Location Btm Btm Btm Btm Btm* Btm Particulate Generation None None None None None Med FAT/SAT/Service/PM/Validation Support Yes Yes Yes Yes Yes Yes Fluid Vortex No No No No No No Tank Materials SST SST SST, Plastic SST Plastic Plastic Sparge Capable No Yes No Yes No No * - Bottom drain for 50L/100L/200L Drums only and open top drain for 300L Drum 23

24 HyPerforma Mixing Solutions Single-Use Mixer (S.U.M.): 50 L 100 L 200 L 500 L 1000 L DS 300: 50 L 100 L 200 L 300 L Mixtainer: 50 L 100 L 200 L 2000 L HyPerforma S.U.M. Animation Video Link Mixing solutions designed to meet your needs 24

25 impulse Mixing Solutions impulse Core: Superior mixing with basic controls and monitors 30 L 50 L 100 L 250 L 500 L 1,000 L 2,000 L 3,000 L 5,000 L 10,000 L impulse Elite: Flexible platform that is customized to your process 30 L 50 L 100 L 250 L 500 L 1,000 L 2,000 L 3,000 L 5,000 L 10,000 L impulse MDS: Superior mixing, modularity with a safe and secure shipping container 30 L 50 L impulse Animation Video Link 25

26 Single-use Fermentors 26

27 Expanding Normal Platform Capabilities Microbial Production Platforms Small, non-glycosylated proteins Perceived as low cost Status Quo Each process developed/qualified de-novo Carries high risk of failure OK 25 years ago now? Current Single-use Optimized for Shear-Sensitive Cell culture Low power input, mixing Limited oxygen transfer rate (OTR) Exhaust management Modified SUB s don t deliver for demanding fermentation processes 27

28 First Large Scale Single-use Fermentation Solution Key Features The S.U.F. is a fully functional fermentor vessel including single-use sterile contact surfaces for mixing, venting, sparging and temperature sensing. Additional ports are included to allow choice of aseptic connections for filling, emptying and sampling. Unique proprietary mixing system enables conventional overhead mixing while maintaining sterility and integrity of the S.U.F. BPC. Minimized vessel footprint and reduced hold-up volumes. Simplified bag loading with a front access door. Side and bottom jacket for effective heat transfer. Cable management system offers greater organization for electrical cables, tubing and line sets while making the unit easier to clean. Dedicated adjustable tool holder keeps necessary tools. State-of-the-art foam sensor that helps prevent exhaust filter failure. Modified SUB s don t deliver for demanding fermentation processes 30 L and 300 L S.U.F. 28

29 Agitation: Drive Train 3 Rushton Impellers Industry standard for rigorous mixing Multiple impellers increase mixing distribution Generates mixing shear and bubble breakup 4 Baffles Breaks up vortex of center driven mixer Converts some radial mixing to vertical Powerful Mixing 100x the nominal power of traditional S.U.Bs 2.27W/L (11hP/1000gal) Low Volume Mixing 5:1 turn down ratio (supports full RPM range) 30L S.U.F. (6L min), 300L S.U.F. (60L min) Volume flexible, high power, uniform mixing 29

30 Storage and Transport Solutions 30

31 HyPerforma Smartainer Systems Stainless Steel Key Advantages Thermo Scientific HyPerforma Smartainer systems have chambers constructed of Thermo Scientific Aegis5-14 Film and CX5-14 Film with dimensions optimized for Smartainer systems. Smartainer systems are simple, durable and economic containers constructed in 304 stainless steel. They are intended for in-house handling applications in critical areas. Smartainer systems are non-jacketed outer container systems available in unit volumes of 200, 500, 1,000, 1,500 and 2,000L. It is a modular system with optional accessories for mobility and BPC handling. Jacketed versions available in all sizes on a custom basis, for applications where heating or cooling are required. Smartainer systems are designed to allow both top and bottom discharge from BPCs. Standard BPC configurations are available in unit volumes of 100, 200, 500, 1,000 and 1,500L. Wide configuration available for 1,000 L 1,500 L using only the ASI 26/77 film 31

32 Accent Outer Support Containers - Plastic Choose from a comprehensive line of economical, standard or fully customizable containers to best fit a variety of applications. There are also standard 3D BPCs for each size, material and configuration with standard port configurations. Key Advantages Standard sizes (100 L 1,000 L) Ease of use and operation Clean room grade swivel casters and wide configurations (available up to 1,000 L) Smooth, clean room grade plastic 32

33 DHX Heat Exchanger A modular heat exchanger that employs a plate and frame concept, using a single-use BPC as the sterile fluid path. 33

34 DHX Heat Exchanger Features and Benefits Single-use, sterile fluid path Completely isolated flow paths for process and heat transfer fluid Small and modular footprint Easy to integrate in new or existing processes Dimpled jacketing on plates provide turbulent flow BPCs fill in place with little operator interaction Reduced infrastructure requirements Reduced processing time Adaptable to your unique process DHX Overview Video Link 34

35 DHX Heat Exchanger Single-use BPC Assembly Single-Use BPC Material of construction: low density polyethylene (ASI 26/77 film) Interconnecting tubing: C-Flex Pressure/temperature rating (Installed in DHX plate system): 20 PSIG at 122 F (50 C) Open architecture connections and assemblies Flow rate capacity: Up to 15 Liters per Minute (LPM) 35

36 insite Integrity Testing System insite is the only true point-of-use integrity testing system that allows users to confirm the integrity of single-use bags inside the tank that is about to be filled. 36

37 insite Integrity Testing System Advantages Using sterile air, the system inflates bags to a precise pressure within the container and monitors for pressure decay that would indicate a leak. Both gross and fine flaws can be detected in any type of bag. Multichannel, point-of-use integrity testing Gross and fine leak detection Guided validation setup Tests BPCs up to 5,000 L Inflation procedure improves loading and placement in tanks Liquid filling cycle regulates internal pressure while fluid is being introduced insite Overview Video Link 37

38 Acclimate Frozen Handling System The Acclimate system is a single-use Bioprocess Container (BPC) and shell combination used for freezing and thawing bio-pharmaceutical fluids in commercial equipment such as walk-in freezers, cold rooms, temperature controlled cabinets or water baths. 38

39 Acclimate Frozen Handling System Features and Benefits Integral BPC and shell in sizes: 2, 6, 12 or 16 Liters Uniform Fluid Distribution Design The acclimate BPCs are designed with patent-pending tuft(s) which help distribute the fluid during filling then holds the fluid in a uniform manner as it expands during freezing Easily fits and Stacks in Commercial Freezing Equipment Optional Sample BPC Capable of Withstanding Temperatures as low as -80 C and thaw conditions to ambient room temperature and maintaining integrity. Pre-assembled Compact and Durable Design Single-Use Pre-sterilized and ready to use 39

40 Three60 Single-use Sampling System The simple design behind the three60 sampling system allows you to take a representative sample of your product with minimal effort. 40

41 Three60 Single-use Sampling System Kit to Tank The Three60 is pre-irradiated and assembled into a one-piece kit. Simply remove the pre-sterilized device from the kit and apply to the vessel. 1: Quick Turn three60 Valve The face of the three60 valve can be sterilized with the tank through traditional CIP / SIP processes. The valve has four sterile assemblies. This keeps the product and technician contaminate free. 2: Pinch and Cut Sterile Disconnections The Pinch and Cut Disconnections allow you to quickly separate the sample and eliminates the need for tools or tube sealing : Injection Ports Luer lock injection site. Extract through either the septum or twist-off luer to pour. 4: Pre-Irradiated Bag Sets ASI provides pre-irradiated bag sets in sizes ranging from 50 ml to 2 Liters. Three60 Animation Video Link 41

42 Precise Single-Use Filling System A small, modular machine that employs disposable tubing assemblies and BPCs to create a clean and efficient method of filling BPCs. 42

43 Types of Precise filling systems Manual Semi-Automatic Semi-Automatic with Integrated Weight Scale Advantages Manual Operation Utilizes off-the-shelf peristaltic Pump for volumetric metering Challenges Manual Operation Fill Accuracy 2% Must be calibrated per batch Semi-automated operation Utilizes off-the-shelf peristaltic pump for volumetric metering Foot Pedal Operation Fill Accuracy 2% Must be calibrated per batch Fill Accuracy +/- 2 ml Programmable Weighing Terminal for product ID storage Per batch calibration is NOT required Variable Fast Feed/Slow feed selection Several programming features including Auto learn (if required) Depending on size of BPC and precise accuracy of the fill, fill times may be slower 43

44 BPC and equipment interface The Precise Filling Connector is an integral part of the pre-irradiated BPC. Simply place the BPC and connector assembly into the cradle and operate the handle or foot pedal. The filling machine will remove the cap, fill to the desired volume and replace the cap into the final closed position The fill connector is a high throughput fluid path and is standard across all BPC sizes (100 ml, 250 ml, 500 ml, 1 L, 2 L, 5 L, 10 L, 20 L) 44

45 Case Study Conversion of a Traditional Facility Into a Flexible Facility Situation Our Response Value Delivered Customer s choice between investment in additional stainless steel facility or SUT High upfront cost for Stainless Steel systems Long set up times & down times during change-over Difficult to change when market conditions change Introduced 500L S.U.B. Installed 2000L S.U.B. in phase 2 Worked with customer to optimize operating conditions to maximize titers Customer experienced 85% reduction in capital equipment investment 2000L S.U.B. performance closely matches performance at bench and 500L scale Ability to build out smaller footprint facility Simplified personnel and material flow 45

46 Case Study Increased Productivity & Reduction in Capital Investment Situation Our Response Value Delivered A large Animal Health company is using micro carriers But it s very difficult to remove from stainless steel parts (i.e., impeller and various ports) In a single-use bioreactor, this difficulty is resolved as all micro carriers from the previous production are disposed. We were selected based on the following: SUT construction materials, like bag sterility, splash proof, resistant to routinely used disinfection methods Reliability and maintenance of products Meeting critical control parameters, like ph, do2, stirring speed Architecture incl. volume range, dimensions (500L S.U.B.) > 80% capital investment saving compared to purchase of stainless steel system Virus yields in the 250L S.U.B. are equal or better than the ones obtained in reference bioreactors 46

47 Your Team BioProduction Account Manager Single-Use Cell Culture Purification Analytics Sales Sales Sales Sales Name: Name: Name: Name: Contact: Contact: Contact: Contact: Technical Expert (FAS) Technical Expert (FAS) Technical Expert (FAS) Technical Expert (FAS) Name: Name: Name: Name: Contact: Contact: Contact: Contact: 47

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