Smart Polymer Parts. Industrialized.

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Sony DADC BioSciences

Meeting the challenges of today’s life science Our unique range of services & and IVD markets competencies

The life sciences and IVD markets continue to grow rapidly · Design for manufacturing driven by both scientific and technological innovation, as · Mastering of micro-features such as channels, well as patient demand. Sony DADC helps companies glob- microwells, micropillars ally respond to the continuing challenges this growth brings · Plating by offering OEM development, mass manufacture and sup- · High precision optical injection molding ply of polymer-based smart consumables. · Automated bonding and lamination of Our services range from design for manufacturing to prototyping, microfluidic chips up-scaling and mass manufacturing, content filling and packaging · Electrode printing on polymers to global logistics. · Surface coating techniques Manufacturing is centered in Salzburg, Austria at our ISO 13485, · Reagent / content loading ISO 14001 and ISO 27001 certified facility. · Automated assembly Already we have delivered solutions to a number of life science · Application QC and IVD innovators, including a consumable chip for Caliper’s · Packaging LabChip®XT platform, RainDance Technologies’ Sequences Enrich- · Logistics including global warehousing, end-user ment Chip and MALDI-MS slides for Shimadzu Corporation. distribution and cash-collection

The advantages of working with Sony DADC for your business

We aim to help life science, diagnostics and pharmaceutical companies significantly increase their business by:

· Establishing long term partnerships for the seamless supply world wide of smart consumables · Providing high quality devices to maximize the number of satisfied consumers who use your products and services · Helping you to capitalize on new and innovative technolo- gies and business models FSBIOS0114E01

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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RainDance Technologies The Sony DADC advantage

RDT 1000 Sequence Enrichment Chip · Translation of PDMS design for prototypes into design for high-volume manufacturing Following a brief from RainDance Technologies, Sony DADC · Mastering developed a state-of-the-art disposable polymer chip to target and amplify hundreds to thousands of specific regions · Fabrication by injection molding of the genome using RainDance’s microdroplet-based PCR · Electrode printing for subsequent sequencing. · Automated multi-component assembly · Packaging The RainDance brief · QC services & conformity with ISO13485 · Initial design to launch in 24 months · Translation of design from prototypes to mass manufacturing · Customized format – replacement of existing PDMS based chip · Reliable manufacturing process (no integrated valves or moving parts for processing of droplets) · Microfluidic chip with through holes comprised of two injection molded parts · Channel flatness & precise cross-sections using exact and repro- ducible automated bonding process · Integrated printed electrodes · Gaskets for interfacing with the instrument at low and high RDT 1000 Sequence Enrichment Chip pressure · Caddy for instrument interface · Serial bar-code – chip/sample identification & tracking · Packaged and labeled – ready for use · Extensive QC · Manufactured in compliance with ISO13485 and GMP

The Sony DADC solution · Single-use chip to eliminate carry-over between samples · Easy isolation and amplification of hundreds to thousands of specific regions of the genome by PCR for subsequent sequencing · Unprecedented sensitivity and specificity for improved data quality Instrument by RainDance Technologies · Improved sample uniformity for less oversampling and efficient utilization of sequencer capacity · Easy transition from benchtop workflow to microscaled high- throughput workflow FSCS0114E02

≥ DESIGN ≥ PROTOTYPING ≥ MASTTERING ≥ MOLDING ≥ COATING ≥ BBOONDING ≥ CONTENT LOADING ≥ ASSSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Singulex The Sony DADC advantage

Following a brief from Singulex, Sony DADC developed a · Smooth translation from prototype to molded microtiter plate that has high optical transparency, high mass-product purity and low fluorescence, all critical properties required · Short iteration cycles for achieving the ultrasensitivity of the Sgx ClarityTM System. · Close collaboration and communication with all team members The Singulex brief · Existing top-class infrastructure including: · Detection vessel with wells for small sample volumes · Cleanroom · Thin well bottom with optical quality fit for confocal · Analytical methods fluorescence measurements (i.e. minimum prism or lens-effects) · Automation capabilities · Low background signal, and minimal dust or material defects in the measurement area · Complete solution that gives the end-user reliable results, even in a non-cleanroom laboratory environment · Cost-effective production method that makes bio-marker testing affordable for everyone

The Sony DADC solution · New plate design based on 96-well microtiter plate format Customized detection vessel · Unique well layout · High-end production methods to fabricate the plate in one shot · A molded plate with high optical quality and low auto-fluorescence · High cleanroom conditions to meet Singulex’ high cleanliness requirements · Design and manufacturing of a dedicated protective cartridge to allow the use in a standard lab environment · Accurate interfacing with the Sgx ClarityTM System

TM FSCS0714E09 Sgx Clarity System

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BBONNDING ≥ CONTENT LOADING ≥ ASSSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Trinean The Sony DADC advantage

DropPlate S, DropPlate D+ · Milestone-based proactive development with instrument developer Following a brief from Trinean, Sony DADC developed microfluidic · Suitability of design and material for high consumables (DropPlate S, DropPlate D+) for Trinean’s high optical quality throughput DropSense96TM spectrometers and its XposeTM Touch&Go sample QC analyser. · High-volume manufacturing · Precision lamination The Trinean brief · Customized bulk packaging · A robust microfluidic chip for easy operation · Application QC and conformity with ISO 13485 · New concept for an affordable microfluidic plastic chip · Design and material for high optical quality down to (=230nm · Design for a single micro-cuvette (DropPlate S) and a two micro- cuvette slide (DropPlate D+) for easy loading of 2 μl samples · Reproduceable high-precision lamination which guarantees flatness and no bonding defects

The Sony DADC solution · Precise lamination to guarantee reproducibility · Fully automated process with 100 % in-line check · Automation eliminates manual handling and hence reduces the risk of contamination Consumable for high throughput spectrometers · Functional testing · Customized bulk packaging · Manufacturing in compliance with ISO 13485

FSCS1114E12 XposeTM for Touch&Go quantification DropSense96TM

1DESIGN 1 PROTOTYPING ≥ MASTERING ≥ MOLDING 1 COATING ≥ BBONDING 1 CONTENT LOADING 1ASSEMBLY 1PACKAGING 1 LOGISTICS Smart Polymer Parts. Industrialized.

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OPKO Diagnostics The Sony DADC advantage TM OPKO Sangia microfluidic test cassette · Precise and automated bonding · Fast scale-up to volume manufacturing Following a brief from OPKO Diagnostics, a division of OPKO Health, Sony DADC produces a key component of the · Step-wise forward integration of the complete OPKO SangiaTM microfluidic cassette to the ISO 13485 quality manufacturing process standard. · Custom packaging · Application QC The OPKO Diagnostics brief · Optimize components for the OPKO SangiaTM test cassette · High-quality microfluidic chip molding · Reproduceable high-precision bonding which guarantees flatness and no bonding defects · Process validation due to automation · Customized packaging solution · Manufacturing in compliance with ISO 13485 and GMP

The Sony DADC solution · Molding of optical clear chip enables automated inspection

· Precise bonding to guarantee reproducibility Bonding of OPKO’s SangiaTM reagent cassette · Fully automated process with 100 % in-line check · Automation eliminates manual handling and hence reduces the risk of contamination · Customized packaging for automated handling at OPKO Diagnostics · Manufacturing in compliance with ISO 13485

Claros®1 in-office analyzer FSCS0714E10 by OPKO Diagnostics

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BBONNDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Anagnostics Bioanalysis The Sony DADC advantage

hybcell technology · One-stop shop solution

Following a brief by Anagnostics Bioanalysis, Sony DADC · Injection molded core with functional coating developed hybcell consumables for multiplex IVD assays on · High-volume microarray production Anagnostics’ hyborg Dx instrumentation platform. · Individual assembly and packaging

The Anagnostics brief · Application QC and conformity with ISO 13485 · Delivery of smart and affordable multiplexing consumables · Injection molding of hybcell core element · Optimization of coating process for perfectly homogeneous biomolecule immobilization · Individual hybcell assembly and packaging of test kits · Design of upscale production process · Development of integrated production strategy

The Sony DADC solution · A technological and production cost breakthrough · Highest batch-to-batch reproducibility ensuring quality of results hybcell consumable for multiplex IVD assays in even the most complex assays · Standardized manufacturing procedures · Rapid production ramp-up to meet demand · Competitive pricing in a cost conscious environment · One partner from development to mass production

Customized content loading · High-volume microarray production · Unique solutions for coating and spotting of cylindric consumable

Complete product solution for Anagnostics Bioanalysis FSCS0114E06

≥ DESIGN ≥ PROTOTYPING ≥ MASTTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Shimadzu Corporation The Sony DADC advantage

FlexiMass™-DS · Design suitable for high-volume production · Mastering Following a brief by Shimadzu Corporation, Sony DADC devel- oped a kit for mass-spectrometry applications in life science and · Fabrication by injection molding IVD, consisting of disposable polymeric single-use MALDI-MS · Back-end processing (coating processes) disposables and a multi-instrument adapter. · Packaging · QC services & conformity with ISO13485 The Shimadzu brief · Logistics · Quality and versatility · Single-use product for IVD applications · 48-well microscope slide format – suitable for manual or auto- mated robotic sample spotting · Inter instrument compatibility · Enhanced flatness meeting the high requirements of MALDI-MS · Conductive polymer material to prevent electric charging · Surface with defined wetting behavior · Serial bar-codes for slide/sample identification & tracking · ISO13485 and GMP compliant · Packaged and labeled for the end-user Packaged and labeled targets

The Sony DADC solution · Multiple end-user benefits · Single-use disposables eliminate risk of cross contamination · Secure sample tracking · Low-cost archiving · Reduced sample preparation time · Compatibility between instruments using slide adapters

Complete product solution by Sony DADC FSCS0114E01

≥ DESIGN ≥ PROTOTYPING ≥ MASTTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Quanterix The Sony DADC advantage TM Simoa · Design for cost-efficient high-volume production

Following a brief from Quanterix, Sony DADC developed a · Optimized design for optimal analytical perfor- state-of-the-art array containing over 200,000 femtoliter-sized mance and results wells and integrated microfluidics. This device is capable of · Fabrication by injection molding automated detection of single molecules for life sciences and · Deformation-free assembly by high-speed in-vitro diagnostics applications. welding

The Quanterix brief · Customized packaging

TM To develop a consumable for its Single Molecule Array (Simoa ) · In-line QC and conformity with ISO 13485 technology. Simoa arrays provide a digital read out allowing the detection of proteins and other analytes with an unprecedented 1000-fold improvement in sensitivity over current methods.

· Increase laboratory efficiency and high throughput workflow with array design · Design of prototypes for mass manufacturing · Integrate arrays and fluidics to enable fully automated load and seal · High integrity manufacturing to improve data quality and precision · High volume, low cost production of arrays · Suitability for life science and IVD applications 24-assay disc · ISO13485 and GMP compliant

The Sony DADC solution

A versatile and cost effective device enabling the next generation of digital molecular diagnostics.

· 24-assay disc array developed with non-contact sample intro- duction port for compatibility with fully automated instrument · Utilizes existing DVD disc manufacturing technology for cost-effective production · Integrated flow cell design · Precision grade markings for disc identification and indexing · Laser bonding facilitates rapid manufacturing · Packaged and labeled for end-user · Compliance with both IVD and RUO markets Simoa HD-1 Analyzer

FSCS0114E04 · Collaboration with the assigned instrument manufacturer Instrument by Quanterix

≥ DESIGN ≥ PROTOTYPING ≥ MASSTERING ≥ MOLDING 1 COATING ≥ BBONDING 1 CONTENT LOADING ≥ ASSSEMBLY ≥ PACKAGING 1 LOGISTICS Smart Polymer Parts. Industrialized.

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Sony Corporation The Sony DADC advantage

Cell Sorting Chip · Milestone based proactive development with instrument developers Following a brief from Sony Medical Business Unit, Sony DADC · Redesign of prototypes to reduce number of developed a novel cell sorting chip for Sony’s new generation manufacturing steps of advanced cell sorting instrumentation system - the SH800 · High-volume manufacturing by injection The Sony MBU brief molding · A robust cell sorting chip for easy operation · Precision bonding · New concept for an affordable microfluidics chip as a replacement · Customized labeling and packaging solution of the conventional flow cell in a flow cytometry instrument · Application QC and conformity with ISO13485 · Suitability of design and material for optical detection and analysis of cells in the chip · Design for quick and easy changeover of that optical component · Development of chips with different orifices suitable for cell analysis and cell sorting · Design - pilot production – pre production and manufacturing · Full assembly and packaging

The Sony DADC solution · Proactive development · Reduction of manufacturing steps by redesign of prototypes: · Integrated molded polymeric orifice Cell Sorting Chip · Labeling by injection molding (logo & type) instead of using stickers · Fully automated bonding with 100 % in-line check · Precise bonding alignment to guarantee reproducible hydro- dynamic focusing and droplets · Cost effective development by using standard microscope slide format · Manufacturing in compliance with ISO 13485

Cell Sorter SH800 Note: final design may vary FSCS0114E07

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BOONNDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Metal Plastics Putz The Sony DADC advantage Coating of LED reflectors · Efficient and reliable sputter coating services at high volumes Following a brief by Metal Plastics Putz (MPP), Sony DADC · Logistics solution to optimize subsequent automated the sputter coating of LED reflectors at high volumes manufacturing and assembly steps at customer including pre-assembly packaging. side: bulk in - trays out

The MPP brief · Close customer interaction for a short set-up · Test and select coating material phase

· Optimize sputter coating process · Speedy execution: 3 months from kick-off to · Scale-up production to several million pieces per year first delivery · Optimize tray packaging for customer’s assembly process

The Sony DADC solution · Improvement of sputter coating regarding · Reflectance · Durability · Thermal load · Color fade-resistance · Cost efficiency and constant high quality due to standardized and fully automated sputter coating process · Delivery of coated product in trays · Stock keeping

· Just in time delivery LED reflector with aluminum coating

...testing different materials for mood lighting applications FSCS0114E08

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Caliper, a PerkinElmer company The Sony DADC advantage

LabChip® XT · Optimized design for best analytical results · Design for cost-efficient high-volume manu- Following a brief from Caliper, a PerkinElmer company, Sony facturing DADC in collaboration with Caliper developed a polymer chip for gel-electrophoresis DNA analysis and DNA fragment · Fabrication by injection molding isolation consisting of a fluidic chip, electrodes and gaskets · Back-end processing (laser welding) for interfacing with the instrument and caddy. · Automated multi component/hybrid assembly – integration of electrodes The Caliper brief · Packaging (heat sealing, blistering) · A practical, robust and versatile biochip · Application QC & conformity with ISO13485 · Time to market 15 months · Cost effectiveness by using standard credit card size format · Integrated electrodes to avoid direct liquid/sample instrument contact · Hybrid/multi component system – laminated card, surgical steel pins, reagent container, designed for heat sealing · Manufactured in compliance with ISO13485 and GMP · Full assembly and packaging

The Sony DADC solution LabChip® XT · Fast, reproducible, high resolution nucleic acid size fractionation, selection and collection · Resulting DNA fragments are tightly sized and are delivered in a buffer compatible with DNA sequencing · The LabChip®XT improves laboratory efficiency and provides sizing that is difficult to obtain using manual methods · Non-fractionated sample can be recollected and used at another time · Reduced unwanted “non-align” reads through tight DNA size selection · Increased average read length by excluding shorter DNA fragments · Faster sample processing maximizes use of sequencer · Reduced waste and exposure to harmful reagents Instrument by Caliper

FSCS0114E03 LabChip is a registered trademark of Caliper, a PerkinElmer company

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BOONNDING ≥ CONTENT LOADING ≥ ASSSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Maven Biotechnologies The Sony DADC advantage

LFIRE™ Label Free Internal Reflection · Translation of glass design for prototypes into Ellipsometry Chip cost-efficient high-volume manufacturing · Mastering Following a brief from Maven Biotechnologies, Sony DADC collaborated with Maven to develop a high-precision · Fabrication by polymer injection molding polymer prism chip with optical coatings, built on their real- · Multilayer coating time imaging technology for label-free cell-based assays and multiplexed biomarker detection. · Surface functionalization · Component assembly and packaging The Maven brief · Development of an optically sophisticated and complete chip · Increase efficiency of low-to-medium throughput laboratory workflows by 16-well design · Optimize optical multilayer coating design for sensitivity · Meet stringent specifications for surface smoothness and birefringence to provide high quality images · Provide functional surface chemistries for specific biological applications Ellipsometry chip · Imprint serial barcoding on chips for identification and tracking · Deliver ready-to-use products: packaged and labeled

The Sony DADC solution · Efficient development paving the way for mass production · Development of injection molded prototypes based on standard slide format mimicking final manufacturing · Specific material selection and injection molding process optimization to meet requirements for birefringence and flatness · Implementation of optical multilayer coating with stable adhesion under biological assay conditions · Scaling of optical and chemical coating processes · Pilot production and manufacturing of LFIRE™ chips packaged and labeled for the end-user

Instrument by Maven Biotechnologies FSCS0114E05

≥ DESIGN ≥ PROTOTYPING ≥ MASTTERING ≥ MOLDING ≥ COATING ≥ BBOONDING ≥ CONTENT LOADING ≥ ASSSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Design for Manufacturing

For a smooth and effective transition from The Sony DADC advantage prototyping to mass manufacturing · Close interaction with the customer to optimize Our offer at an early stage: · Design optimization for mass-production · design of plastic parts · Application driven design optimization · production conditions

· Simulation of computational fluid dynamics · biochemical assay conditions

· Various prototyping solutions for time and cost What we consider efficient implementation · Choice of material based on assay conditions · Design history file for medical or IVD products · Compatibility of shape/design with devices · Standardized formats of production and packaging (e.g. credit card · Proven collaboration with instrument manufacturers format, microscope slide format)

· Robustness of manufacturing process Design of features in relation to ejector pins · Small footprint Injection molded part · The 3 C’s (cost, cost and cost)

Variety of polymers · Proven expertise to convert glass, silicon and metal to polymer e.g. Master · PP · PC · COC/COP Ejector pins Ejector pins · PMMA Close interaction between instrument and consumable manufacturer · PS

Simoa HD-1 Analyzer Simoa disc FSTS1213E08 Instrument by STRATEC Biomedical AG Consumable by Sony DADC

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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“Realistic prototyping” Prototyping by 3D printing

Step 1: CD molding Visualize your ideas with 3D printing Step 2: Milling/cutting Step 3: Bonding/Lamination Options for 3D printing Step 4: Coating · Hard plastic for chips or caddies · Soft plastic for gaskets Our offer · Different colors or transparent options · Multilayer structure options · Rapid and efficient de-novo prototype development with short iteration cycles · Injection molded prototypes enable biochemical assays and Benefits of 3D printing by Sony DADC production processes to be optimized at an early stage · Earlier final product impact evaluation · Injection molding with existing tools · Injects realism to partnering and fundraising activities · Subsequent laser machining or micro milling · Optimizes mechanical fit and ease of handling · Fast and cost effective alternative to pure injection molding · Chip-adapter · Chip-caddy Benefits of prototyping by Sony DADC · Chip-instrument · Prototypes with the dimensions of the final product: · Chip-packaging · Optimizing biochemical assay conditions with the final material · Optimizing high-volume production conditions with the final material · Rapid iteration time

Chip adapter for measurements

The Sony DADC advantage

· Standardized formats e.g. CD format for cost efficient prototyping

· Fully functional prototypes for optimizing the final production process

· Rapid prototype development with short iteration cycles Gold coated and transparent prototypes for Axela FSTS1213E09

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Mastering The Sony DADC advantage Silicon precision in plastics · Design for manufacturing · Reliable manufacturing of micro/nano features Our capabilities · Multi height features · Multi height features · Aspect ratios up to 12:1 · Aspect ratios up to 12:1 · High density arrays · Small structure sizes down to 150 nm · Many options for customized mastering are Options for customized mold insert fabrication available · Standard methods · Precision milling · Diamond cutting · Advanced methods · Laser lithography · Phase transition mastering – based on Sony’s proprietary high

resolution master technology for Blu-ray discs · Micro stereolithography · Silicon etching (DRIE) · Electroforming of silicon or glass master supplied by customer

Benefits of mastering by Sony DADC · Design review and design for manufacturing SEM picture of an injection molded polymer part (lithography master, 2-heights) · Reliable manufacturing of micro/nano features · High aspect ratio, low side wall roughness and adjustable draft angle (less than 1°-10°) · Realization of sophisticated multi-level designs for microfluidic components · e.g. flow rate controller, mixer/merging chambers, particle filter, cell sorter, well arrays · Combination of micro-/nanometer features with fluidic components · e.g. surface structured fluidic channels · High-class measurement equipment to verify customer design specifications (e.g. AFM, SEM)

SEM picture of an injection molded polymer part

FSTS0214E10 (silicon DRIE etched master)

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Molding The Sony DADC advantage Polymer Injection Molding for Life Science · OEM manufacturing – set-up process & manufacturing consumables · Up-scaling – optimizing cycle times SOP More and more high quality components for life science and · QA, reliability & conformity with ISO13485 diagnostic applications are produced using polymers. Three · Co-development – part & process development key factors are driving this trend: · Material selection · After creating a mold, polymer chips can be manufactured in high · Dimensions & tolerances volumes more cost effectively than glass with a minimum of · Physical properties working steps. · Set-up process & manufacturing · A wide variety of polymers with different physical and chemical properties are now available in the market, enabling the replace- Core capabilities ment of traditional materials such as glass, metal or silicon etc. · Prototypes can be molded in disc format with short · Plastics offer greater scope in terms of product design. Even highly lead time complex structures can be reproducibly manufactured in high · Specific molding technologies (e.g. variotherm, volumes. injection compression) · Aspect-ratio > 10:1 is possible The challenge is to strike the right balance between superior quality and high cost effectiveness – and this is where Sony DADC is ideally placed to deliver.

We have invested heavily in building a global network of state-of- the-art manufacturing. All critical production phases are computer controlled and assembly is based around high-speed robotics.

This integrated and flexible approach enables Sony DADC to offer you efficient mass production of your customized product from quantities as low as hundreds up to millions of units.

Benefits of injection molding · Fully automated scaleable one-step production Fully automated production · No demolding agents used – minimal influence of polymer on assays · Low background fluorescence · Superior flatness similar to the best microscope slides · High replication accuracy · Extensive in-line QC

FSTS0114E02 Efficient mass production

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Coating The Sony DADC advantage

Industrialization of functionalized surfaces · Various coating solutions · Single or multilayer coating Get your polymer part functionalized · Uniform or pattern coating · Physical properties · Almost endless options by coating · Optical coatings – e.g. filters for light, waveguide layers, · Controlled processes by automation antireflection coating, silvering · High expertise in materials & applications · Defined wetting behavior for reproducible sample · ISO13485 certified and GMP ready preparation · Tight vapor barrier avoids interaction between sample and plastic or its additives · Conductivity avoid build up of static charges · Super hydrophobic surfaces (e.g. electrowetting applications) · Change of surface energy (e.g. hydrophilic) · · Chemical properties · Linking of functional groups · Prevention of unspecific adhesion (e.g. protein adhesion)

· Adhesive layer (e.g. SiO2 for amino-silane or epoxy silane coating) · Glass like coating – mimic glass like reaction conditions · Chemical resistance Functional coating · Biological properties based on your requirements · Immobilization of biomolecules · Tissue culture applications

Coating services by Sony DADC · Sputter coating · Chemical or physical coating · Plasma treatment

Benefits of coating by Sony DADC · Industrialization · Robust and reproducibility processes for mass production Various coatings - functional & esthetically pleasing · Customized solutions · Design for manufacturing FSTS0214E05

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Printing of conductive & functional materials The Sony DADC advantage

Wide choice of printable materials · Wide range of printable materials · Conductive materials (silver, gold, platinum) · Different printing/deposition techniques

· Functional materials (Al2O3, fluorophores) depending on application · Graphical printing · Scale up from prototyping to fully automated solutions for mass production possible Suitable deposition technologies for many applications · Customized solutions · Inkjet (contact-free, lines & spaces >5 μm) · Offset printing · Screen printing · Micro dispensing

Field of applications · Biosensors · Printed electronics · Modification of surface properties

· Product codes/graphics Printing electrodes

Printing process · Modification of surface properties Plasma treatment, coatings, microstructured surfaces · Modification of printing materials Choice of organic solvents, adjustment of solid content or viscosity and surface tension · Drying and Sintering Thermal, UV/IR · Inline vision inspection systems High edge definition and perfect alignment to other functional structures Benefits of printing by Sony DADC · Form resistant and edge definition · Perfect alignment to other functional structures · Customized solutions from prototyping to high volume production · In-line QC with vision inspection systems · Cleanroom conditions

FSTS0214E11 Vision inspection system

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Bonding The Sony DADC advantage For fully automated & integrated manufacturing · Fully automated solutions – reproducible and clean Many options for customized bonding · Most stringent in-line QC for reliability of · Thermal fusion bonding product · Solvent bonding · Adhesive-free bonding interface · Pressure sensitive adhesive bonding · Many options for customized bonding are · Continues laser welding available · Mask laser welding · UV activated gluing · Ultrasonic welding · Lamination · Combination of the above

Full integrated bonding lines · Formats between cover glass and MTP size · Rigid parts · Elastic parts · Thin film · Membranes Fully automated bonding · Hybrid part bonding (e.g. plastic-glass)

Benefits of bonding by Sony DADC · Reproducibility and precision · Microstructure bonding (down to 5 μm) · Exact structure geometry · Accurate component alignment (down to 20 μm) · High bonding force · High optical quality · Annealing/tempered/conditioned · Decreases the risk of shape change during shipping · Stress reduction in the plastic parts Optimizing bonding processes · In-line QC · Visual check for flatness, contamination & structure shape · Cleanroom conditions FSTS0114E06

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Content Loading The Sony DADC advantage Industrialization of functionalized consumables · ISO 13485 certified and GMP ready

Content filling · Many options for customized content loading are available · Customized content filling or pre-loading of lab-on-a-chip consumables · Controlled processes by automation · Liquids and solids, planar or localized on chip · Variable volumes (pl to ml) · High expertise in materials and applications · Contactless dispensing/spotting · Distribution (e.g. frozen cargo) · Diverse reagents (biological, chemical) · In combination with suitable packaging · Packaging of reagents-kits · Sterile – dust-free – shock proof – non degassing – waterfree

· Blister packaging – vacuum – inert gas filled e.g. N2 · Chilled products and frozen cargo

Benefits of content loading by Sony DADC · Industrialization · Robust and reproducibility processes for mass production Spotting of content · Customized solutions · Design for manufacturing · Prototype test spotting to high volume production · Optimizing processes · Large choice of systems (pl to ml) · Content gets optimized on substrate properties

hybcell consumable Test-kit for Anagnostics Bioanalysis including hybcells and reagents for multiplex IVD assays FSTS0214E12

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

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Assembly The Sony DADC advantage Custom / semi-automated / fully automated · Fully automated assembly · Fully integrated into manufacturing process For every customer`s specific needs, we can develop a made- · Seamless in-line QC to-measure assembly solution enabling semi-automated / fully automated assembly, full integration into the manufacturing · Dealing with full range of product features, process and automated in-line QC. from low to high volume and complexity

Benefits of assembly by Sony DADC · Insertions of pins or gaskets · Integration of MEMS, electrodes, etc. · Mounting of chips into caddies · Gluing · Laser welding · Sealing · Application of stickers ·

What do we assemble? · Chips Fully automated insertion of pins · Caddies · Carriers · Adapters

In-line QC (selected options) · Optical checks for defects and completeness · Pressure checks · Flow checks for droplet formation · Adhesion checks · Manual checks · Fully automated QC including automated check and feedback Fully automated assembly line loop from database developed by Sony DADC FSTS0214E13

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

biosciences.sonydadc.com

Packaging Single vs. multi packaging Depending on your specific requirements, we supply Protect and promote your product with the your custom chips in single or group packaging: right packaging · Stacked or tubular pouches · Blister for individual shaped chips Sony DADC has the experience in manufacturing and logistics · Holders for multiple CD-shaped chips to add value at every stage of the supply chain, right through to packaging. Whether your chips are of standard · Boxes with customized comb slots in 90 degree size or fully customized, Sony DADC offers robust, cost- placements for individually sized chips effective packaging solutions to meet your requirements and all relevant international standards completely.

Standardized vs. individual packaging Our standard solutions will suit most applications, e.g. standard microscope slide-sized chips can fit in sets of five in automated packaging with labels and barcodes on demand. However, if you have an innovative product that is literally “out of the box”, we can design a customized solution: · Sterile – dust-free – shock proof – non degassing Packaging solution for Sony · Vacuum – gas filled e.g. He, N2 · Different materials e.g. cardboard or plastic Labeling and barcoding Labels and box designs are offered as an integral part of Sony DADC works customer-oriented and ensures that all Sony DADC’s packaging solutions: corporate design needs are met. · Instruction sheets and seals · Sticker coding for lot batch tracking or temperature logging · RFID tags

The Sony DADC advantage

· Extensive experience in world-wide logistics – we know the customer‘s needs

· Deep expertise in ISO 13485 compliant manufacturing – we know the international quality standards

· Wide range of standard solutions covering most applications Packaging solution for Shimadzu Corporation · Affordable customized solutions FSTS0114E04

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

biosciences.sonydadc.com

Sony Deutschland GmbH The Sony DADC advantage Materials Science Laboratory Undesired phenomena? Surprising effects? Needs Trouble shooting, in-depth analysis and of a surface with specific properties? When it comes to material problems the MSL has the capability customized surfaces and expertise to provide answers and solutions.

Sony DADC BioSciences closely cooperates with the Materials Science Laboratory (MSL) of Sony Deutschland GmbH in Stuttgart. Selection of analytical options Services Analysis on/in surfaces, thin films and bulk (gas, liquid and solid state) · Qualitative and quantitative chemical characterization of materi als or contaminations (bulk or surface) · Microscopy (nm-cm): electron microscopy (TEM, · Comprehensive chemical and topological surface characterization SEM with EDX), scanning probe microscopy (STM, · Material based product improvement AFM, cAFM, KPFM), fluorescence microscopy, confocal Raman, infrared (IR) · Surface treatments to achieve specific properties · Development of customized coatings · (atomic and molecular): XRF, NMR, FT-IR (PMIRAS), UV-VIS, time solved Facts fluorescence (ps-sec), XPS · International team of scientists and engineers covering chemistry, · Chromatography: GC/MS, HPLC/MS, GC/FID physics, biology and electrical engineering · Thermal analysis: DSC, TGA · 1300 m2 of lab space · More than 50 state-of-the-art characterization techniques and · Environmental analysis: emission test chambers high-end customized equipment · Other physical methods: particle sizer, ellipsometry, contact angle geniometer, BET, Coatings and surface treatments profilometer, zeta potential and Kelvin Probe on · Vacuum coating techniques: physical and chemical planar systems · Wet chemical processes: spraying, dipping, spin casting, etching · Plasma treatment

Failure Analysis Surface treatment 20 OK sample 10 0

20 NG sample 10 0

Absorbance Units [kCPS] 800 600 400 200 0 Binding Energy [eV] Before After In-depth analysis and customized surfaces: XPS spectra for Surface analysis via XPS Ultramicrotome for FSTS0314E07 failure analysis (l) and contact angle measurement (r) sample preparation

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

biosciences.sonydadc.com

Logistics The Sony DADC advantage

Because your product just can’t wait · Reduced overall turnaround time

Whether it is important experimental data or life saving · Increased order flexibility medical decisions, your customer expects an immediate · Environmentally aware and efficient response. Therefore efficient logistics are essential. Use Sony transportation DADC as both your manufacturer and logistics partner and you can be sure your products will be available to your cus- tomers - whenever and wherever required.

Seamless logistics As your single point of contact, Sony DADC can cover the entire supply chain – from the receipt of your input data to the delivery of shelf- ready products. Add to this fact that Sony DADC is both a manu- facturer and a distributor and you get unbeatable service covering: · Order management · Receiving / putaway Ex factory · Warehousing / inventory management · Order picking / quality control · Shipping / transport management · Invoicing, credit & cash collections

A proven network Over the last decade we have developed one of the world’s most sophisticated logistics networks - first for CD/DVD/BluRay products and now smart consumables for the biotech and medical industry. Customized state-of-the-art IT systems and a worldwide network of distribution centers and delivery partners guarantee unrivalled World’s most sophisticated logistics networks levels of efficiency, flexibility and reliability.

A dedicated team We have a team of logistics specialists who will analyze your par- ticular needs and devise a customized solution. Get in touch for an initial consultation.

FSTS0114E03 Structured distribution center

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS Smart Polymer Parts. Industrialized.

biosciences.sonydadc.com

Quality Assurance & Quality Control Our dedication to QA & QC guarantees Parameters you can trust your success QA for IVD and FDA markets Achieving the highest possible levels of quality has always · Sony Six Sigma been one of Sony DADC’s key principles. We believe our · Kaizen strong focus on compliance, supply reliability and business · ISO 13485, 14001, 27001 process excellence, together with our unwavering commit- ment to meet customer needs, create the basis for a competi- QA & QC – Services tive, best-in-class commercial service. · Risc assessment (FMEA according ISO 14971) · Functional application QC In life sciences and IVD diagnostics, such a best-in-class quality sys- tem enables us to comply with the requirements of both small and · Optical and mechanical metrology at micron level large manufacturers. · Material characterization

All development and product realization processes are controlled · Surface profiling at nm resolution by key performance indicators. The QA system is fully integrated · CAQ system and comprises all raw material and component suppliers as well as · CAPA management transport operations. QC – Equipment Our continuous focus on meeting and exceeding customer require- ments, and continuous improvement in our product and service · SEM (scanning electron microscope) provision is enabled by Sony Six Sigma improvement projects and · Confocal microscope controlled by a corrective action/preventive action system in order to · Light microscopy maximize quality and service standards within all of our operations. · Optical profilers Naturally, all our activities for the in-vitro diagnostics industry are · In-line visual checker, ... ISO 13485 certified. Quality Furthermore, everyone in Sony DADC contributes to customer sat- · Highest & consistent quality isfaction. Quality is not only the responsibility of the quality depart- · High-speed inspection ment: each employee is responsible for the quality of his/her work · Functional check for final products individually and as part of a team. · Optical in-line quality check for each product So how do we define quality at Sony DADC? Quite simply, it means · ISO 13485, 14001, 27001 certification that customers can rest assured that they will receive what was or- dered: complete, defect-free, in time, and without any security issues. FSTS0114E01 Optical measurement for quality control

≥ DESIGN ≥ PROTOTYPING ≥ MASTERING ≥ MOLDING ≥ COATING ≥ BONDING ≥ CONTENT LOADING ≥ ASSEMBLY ≥ PACKAGING ≥ LOGISTICS