Smart Polymer Parts. Industrialized. biosciences.sonydadc.com 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. biosciences.sonydadc.com 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. biosciences.sonydadc.com 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. biosciences.sonydadc.com 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. biosciences.sonydadc.com 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. biosciences.sonydadc.com 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 ·