Lateral Flow Assay Development: DCN
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Lateral Flow Assay Development: DCN

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DCN is a provider of services and products to developers and manufacturers of rapid assays. We specialize in quantitative, multiplexed, fluorescent or visual lateral flow assay systems, and can ...

DCN is a provider of services and products to developers and manufacturers of rapid assays. We specialize in quantitative, multiplexed, fluorescent or visual lateral flow assay systems, and can develop and integrate the complete system, including assays, cassettes, sample handling devices and readers. We also provide Education and Training in Lateral Flow Technology Courses, a broad range of consulting services, and a catalog of associated materials, kits, colloidal gold and custom conjugates. This presentation outlines our major capabilities and services

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Lateral Flow Assay Development: DCN Lateral Flow Assay Development: DCN Presentation Transcript

  • Complete, creative solutions for developers and manufacturers of rapid assays
  • DCN History and Capabilities • Founded in 2006 as a developer of rapid assay technologies • We assist organizations in the development, manufacturing and commercialization of rapid lateral flow, flow through and microfluidic assays for any market segment. • Over 50 successful programs since 2005. • Quality System: – ISO 9001-2008 – EN13485Complete, creative solutions for developers and manufacturers of rapid assays
  • Facility and People • DCN operates from 9,000 square foot facility in Carlsbad, CA – 3000 ft2 of clean lab space (class 10,000 capable clean room) – Environmentally controlled development and assembly lab • Full range of lateral flow development and manufacturing equipment • 23 people, 20 highly experienced development scientists; 4 PhD’s , 10 developers with in excess of 15 years’ lateral flow development and manufacturing experience each, from large Dx companies • 7 working languages, including Mandarin, Japanese, Spanish and French Reagent Prep Area Main Lab (Class 10,000 capable Component Processing Area cleanroom) (Temperature / HumidityComplete, creative solutions for developers and manufacturers of rapid assays Controlled)
  • DCN is the leader in contract development of high end rapid immunoassays. Representative Clients Include: • BioRad (US/EU) • Johnson and Johnson (UK) • Chiron Corporation (US) • Novozymes (Denmark) • Amgen (US) •3M (US) • AstaZeneca • Amic (Sweden) • Pall Corporation(US) •Critical Diagnostics (US) • Aspen BioPharma (US) •GE Healthcare (US / Europe ) •WL Gore (US) •Elixir Biosciences (China) • Pacific Biotech (Thailand) •Span Diagnostics (India) •Astute Medical (US) • Daiichi Fine Chemical (Japan) •Church and Dwight (US) •Becton Dickinson (US) • Monsanto •Mintek (South Africa) • Kimberly Clark (US) • Biominas (Brazil) • Government of Thailand • CETEC (Brazil) • Orasure (US) •FioCruz (Brazil) • CDC (US) • MARS/Masterfoods (UK)Complete, creative solutions for developers •FABPulous (Netherlands) rapid assays • GTI/Genprobe (US) and manufacturers of
  • Our Markets •Our market is Medical Diagnostics international and spread Veterinary Diagnostics over multiple Agricultural / application areas. Environmental Food Testing •Approximately 40% of OTC/Consumer our assay development Pharmaceutical programs are US-based, 40% are European and Industrial Health and Safety 20% are spread among Biowarfare Asia and South America Law enforcement / Forensics •Over 40 completed Microbiology development programs Nucleic Acid Testing since 2005Complete, creative solutions for developers and manufacturers of rapid assays
  • Complete, Creative Solutions for Rapid Diagnostic Test Developers and ManufacturersComplete, creative solutions for developers and manufacturers of rapid assays
  • Assay Development Services • Quickly develop and commercialize rapid assays for any application • Experienced with fluorescent, visual (colloidal gold / latex) and paramagnetic labels – From concept to commercialized assay in under 12 months – ELISA conversion to rapid assay formats in short timeframes – Reagent sourcing and development – Rapid prototyping – Feasibility studies – Complete development – Manufacturing transferComplete, creative solutions for developers and manufacturers of rapid assays
  • Integrated System Design and Development Cartridge top housing • DCN can develop and commercialize all aspects of RF id tag a point of care diagnostics platform, through our in- Strip and Assay Cartridge bottom housing house capabilities and our Network of Affiliates Desiccant • Custom design and integration for high performance assays our specialtyComplete, creative solutions for developers and manufacturers of rapid assays
  • Education and Training Services • Learn how to develop and manufacture lateral flow assays • Customized one-on-one courses held at DCN’s core facility in Carlsbad, California • Scheduled on demand • Duration 3 – 5 days • Theoretical and practical elements covered • Bring your reagents and optimize an assay during the courseComplete, creative solutions for developers and manufacturers of rapid assays
  • Contract Manufacturing • DCN’s facility is completely equipped for manufacture of lateral flow, flow through, and other format point of need assays • The facility: – 8000 square feet, containing 4,000 square feet of wet lab, housed in a class 10,000 capable cleanroom, with controlled humidity room (<15%R.H. ) – ISO 9001:2008 and EN 13485 compliant • We additionally Partner with several contract manufacturers to whom we can transfer product after development is complete. Reagent Prep Area Component Processing Area Main Lab (Class 10,000 capable (Temperature / cleanroom) HumidityComplete, creative solutions for developers and manufacturers of Controlled) rapid assays
  • Custom Conjugate Development and Manufacture • Expertise in covalent conjugations – Protein / peptide /small molecule – Particle • Colored, fluorescent or paramagnetic latex, gold, quantum dots, etc. – Protein – Protein • Full optimization process • Full QC including binding assays where reagents are availableComplete, creative solutions for developers and manufacturers of rapid assays
  • Consulting Services DCN has over 25 consultants on staff that can provide a wide range of services related to the point of need diagnostics or detection business: • Regulatory Affairs • Project management • Risk assessment • Intellectual property landscaping • Manufacturing process development • Assay troubleshooting • Quality system establishment Device design • Facility setup • Equipment specification and procurement • Market evaluation • Technology evaluationComplete, creative solutions for developers and manufacturers of rapid assays
  • Products DCN provides everything needed to develop or manufacture lateral flow or flow through assaysComplete, creative solutions for developers and manufacturers of rapid assays
  • Products High quality gold colloids • 20nm, OD 1-10 • 40nm, OD 1-10Complete, creative solutions for developers and manufacturers of rapid assays
  • Products Material and Reagent Kits Material Starter Kit Gold Conjugation Kit Latex Conjugation KitComplete, creative solutions for developers and manufacturers of rapid assays
  • Products Lateral Flow Test Strip Readers ESE (Qiagen) LRE (Esterline) Alverix Axxin Detekt SkannexComplete, creative solutions for developers and manufacturers of rapid assays
  • DCN’s Network Partners DCN’s Network of Affiliates is a group of closely knit companies that work together to provide all of the key elements necessary to design, develop manufacture and commercialize point of care diagnostic systems. Member companies include: • Manufacturing equipment suppliers • Cassette and device designers • High volume molding companies • Materials converters • Reader developers and manufacturers • Contract manufacturers • Platform technology suppliersComplete, creative solutions for developers and manufacturers of rapid assays
  • DCN Provides User-Centric Design and Development of Complete Assay Systems Assay Design and Components Signal generation Biological recognition reagents technologies Sample collection and handling methods Device (cartridge) design Manufacturing Process Interpretation and signal transductionComplete, creative solutions for developers Design technologies and manufacturers of rapid assays
  • Representative Assay Development Projects Infectious Disease • Anti HIV 1 / 2 (serum, whole blood, plasma, saliva) • Dengue antigen and antibody (serum, plasma) • Hepatitis B (serum, whole blood, plasma) Human Biomarkers • Appendicitis protein marker, quantitative (serum, plasma) • Kidney disease panel, quantitative (serum, plasma) • hCG, standard, extreme dynamic range (urine, whole blood) • Cardiac markers TnI, CKMB, Myoglobin, FABP (serum, whole blood, plasma) • Progesterone (tears) • E1G and PdG quantitative (urine) • Antibodies for Heparin Induced Thrombocytopenia, quantitative (serum, plasma) Veterinary • Bovine early pregnancy marker, quantitative (urine) • Equine colitis (feces) Other • Alpha amylase, quantitative (wheat) • GMO protein expression (soybean) • E coli 0157 (food) • Drugs of abuse panels (urine) • Caffeine, quantitative (beverages)Complete, creative solutions for developers and manufacturers of rapid assays
  • Complete, creative solutions for developers and manufacturers of rapid assays