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Summary of Content

BioIC Platform and Technology Mickey Tai Director, CTO R & D Division Agnitio Science & Technology Inc. lw.tai@agnitiost.com 14 th October , 2016. Summary of Content. Company Profile Product Introduction Principle of Design Manufacture Procedure Quality Control. Safety of Product

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Summary of Content

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  1. BioIC Platform and TechnologyMickey TaiDirector, CTOR & D DivisionAgnitio Science & Technology Inc. lw.tai@agnitiost.com14th October, 2016

  2. Summary of Content • Company Profile • Product Introduction • Principle of Design • Manufacture • Procedure • Quality Control • Safety of Product • for Developing • for User • for Reports • Agnitio R&D

  3. Company Profile ─ Milestone Agnitio Science and Technology, Inc Founded in ITRI Hsinchu Taiwan Established in Hsinchu Science Park Develop BioIC System GMP ISO 13485 BioIC System, Received Taiwan TFDA Approval

  4. Company Profile ─ Milestone Taiwan Marketing China Distributor Europe: CE Marked China: CFDA Approval SE Asia: Vietnam, Malaysia, Indonesia , International Exhibition EastAsia: South Korea 2011 2009 2015 2016 2017 2010 BioIC System, Received China FDA Approval Enter European Market: Poland,

  5. Product Introduction • “ BioIC system includes microfluidic cartridge and analyzer • that is designed to screen a panel of protein semi- quantitative ELISA assays • to be used in hospitals/labs. Such as allergens/cytokines panel screening and other applications ”

  6. Operation Procedure of BioIC Allergen Specific IgE Detection System Automation

  7. Principle of Design Concept of Lab on a Chip

  8. BioICMicrofluidic Cartridge • Concept of Lab on a Chip • Tubing Free and Close System • Reduce the space and equipments of lab • Convenient Operation • Fast testing time • Reduce the volume of reagents • Avoid the contamination Microfluidic Automatic ELISAPlatform

  9. The Fusion of Technologies Image process Ultrasonic surface treatment

  10. BioIC Microfluidic Immunoassay Cartridge ELISA reaction zone Microfluidic pumps Reagent and Sample tank Upper layer Selected proteins and controls are pre-spotted onto a NC coated silicone rubber according to different assays. Inter layer Bottom layer Waste tank

  11. Microfluidic Pumps Structure

  12. BioIC Instrumentation

  13. Indirect ELISA Immunoassay Blocking Step

  14. Protocol for Running Allergy Detection Assay Warm Up (37 ℃) Blocking Step (Incubate for 3 minutes) Wash Protocol Serum Step (Incubate for 10 minutes) Wash Protocol Anti-Human IgE HRP-Conjugated Step (Incubate for 10 minutes) Wash Protocol Substrate Step (React for 30 sec, Expose for 2 minutes) Image Capture Image Processing Date Generation 1 to 7 are Completed By Pumping Machine * Rest steps need to be completed within 30 min 1 to 11 are Completed By Analyzer

  15. Seeded Region Growing Algorithm (SRG) Positive Intensity: Foreground • 20 X 20 = 400 pixels • Intensity = • Foreground – Background • 260 = 282 – 22 • 3. Noise Control Background

  16. Seeded Region Growing Algorithm (SRG) Negative Intensity: Foreground • 20 X 20 = 400 pixels • Intensity = • Foreground – Background • 15= 18 - 3 Background

  17. Algorithm Raw Images Dot Integration (LU) 0 1.2 2.4 AU 0 1 2 Class

  18. Calculation Algorithm • Internal Calibration Curve • Traced back to a well known specific allergen IgE concentration (IU/ml) • Quantitative System • Class Classification • Interpolation

  19. Comparison Study

  20. Manufacture ─ Procedure Surface Treatment Protein Array Spotting GMP Manufacture Materials Preparation Heat staking Product Quality Control

  21. GMP IQC PQC FQC Audit ISO 13485 Manufacture ─Quality Control

  22. Quality Control Standard • Provide a standard, which is defined already for positive level of each allergen marker, to control the process and quality of manufacture. • Quality Control Standard Database • Confirm the process and quality of manufacture • Positive pooled seraor plasma as the materials of standard • Developing mono-clone antibody for quality control

  23. Design Input, Design Output, Trial Run, Production Developing Validation Production Certificate of GMP, ISO13485 Clinical Trial Clinical Trial in Taiwan and China Certificate TFDA, CE marked Safety of Product ─ for Developing

  24. Design Input & Output Input Output Marketing Research Company Direction Products R & D Development Research QA MF Customers

  25. IP, Regulation Marketing Paper Company Direction Idea Survey Design Input R & D Specification Design Output Research Clinical Info Prototype Products QC Pilot Run Production Trial Run Products Spec Performance Test PE Batch Production Products Mass Production

  26. ISO13485 GMP FDA Approval─Taiwan Machine Approval─Taiwan Machine Approval─China CEMarked Certificate

  27. Safety of Product ─ for User • Tubing Free and Close System • Easy Maintainance • Design of Waste Tank • Disposable design to avoid the contamination in testing

  28. Safety of Product ─ for Report Design of Report Validation

  29. Internal Calibration Curve : Linearity R2> 0.95 • Negative Control : Make sure the background is normal • One of them failed, the report is invalidated • To avoid the abnormal serum sample and the abnormal procedure of testing

  30. GMP Report Validation IQC PQC FQC Audit ISO 13485 QC of Manufacture QC of Testing

  31. Agnitio R&D Core • Microfluidic System • NC Spray Technique • BioIC System • Microfluidic Cartridge • NC Spray • Microarray • Heat stake • Software (LabIT) • ELISA • Chemiluminescence Based Detection • Protein Lab

  32. Agnitio R&D Current Works R & D Cooperation Development Research Protein Lab Allergen Extract Bio-Application New System Antibody Extract Quantitative Auto-System NC Slide Platform Cost Down Allergic Test QA Slide Dispenser S-IgE Standard System 2nd Source BioIC2400 S-IgG4 System Standard for QC Beta-Pumping Machine Recombinant Protein Regulation and Approval

  33. Protein Extraction Lab BioIC Platform (ELISA Assay) Platform Automation Allergy Application Other-Applications • Increase Detection Items • Specific IgE, IgG4, and cytokine Detection • Allergen Extraction • Recombinant Protein Detection Glycanin Cancer Diagnosis Project Autoimmune Project

  34. BioIC Application Development Increase Detection Items, ex. 40 80 or more allergens Increase Detection Fields Allergen Detection Cytokine Detection Tumor Marker AFP CEA CA-125CA-199CA-153 PSA Sugar Markers TORCH Toxo IgG/IgM Rubella IgG/IgM CMV IgG/IgM HSV-1 IgG/IgM HSV-2 IgG/IgM Cardiac Marker Troponin I Myoglobin HS CRP CK-MB Myeloperoxidase Thyroid TSH U-TSH T-3 T-4 Free T-3 Free T-4 Molecular Biological Detection Product Developing Product Completed Enter Market Other Possible Products:H. pylori IgG/IgMInfection Disease Detection Hormone Detection

  35. 2nd Ab (Mab anti H IgE-HRP) Purified Ag Stablizer Allergen Materials Quantitative Improvement Error function Ag + Component Source (Greer, DST, Diater) Materials pre-evaluation Filing Inhibition test (compare with CAP Regulation New Panel Filing Standard Control Component Ab (AllerMAbs) Pooled Sera (PlasmaLab) Immuno Ab (DCB)

  36. Thanks

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