Lateral Flow Assay Development: DCN

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

– EN13485


• 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

Facility and People

Reagent Prep Area Main Lab (Class 10,000 capable cleanroom)

Component Processing Area (Temperature / Humidity Controlled)


DCN is the leader in contract development of

high end rapid immunoassays. Representative Clients Include:

• Johnson and Johnson (UK)

• Novozymes (Denmark)

•3M (US)

• Amic (Sweden)

•Critical Diagnostics (US)

•GE Healthcare (US / Europe )

•Elixir Biosciences (China)

•Span Diagnostics (India)

• Daiichi Fine Chemical (Japan)

•Becton Dickinson (US)

•Mintek (South Africa)

• Biominas (Brazil)

• CETEC (Brazil)

•FioCruz (Brazil)

• MARS/Masterfoods (UK)

•FABPulous (Netherlands)

• BioRad (US/EU)

• Chiron Corporation (US)

• Amgen (US)

• AstaZeneca

• Pall Corporation(US)

• Aspen BioPharma (US)

•WL Gore (US)

• Pacific Biotech (Thailand)

•Astute Medical (US)

•Church and Dwight (US)

• Monsanto

• Kimberly Clark (US)

• Government of Thailand

• Orasure (US)

• CDC (US)

• GTI/Genprobe (US)


Our Markets

Medical Diagnostics

Veterinary Diagnostics

Agricultural / Environmental

Food Testing

OTC/Consumer

Pharmaceutical

Biowarfare

Law enforcement / Forensics

Microbiology

Nucleic Acid Testing

Industrial Health and Safety

•Our market is

international and spread

over multiple

application areas.

•Approximately 40% of

our assay development

programs are US-based,

40% are European and

20% are spread among

Asia and South America

•Over 40 completed

development programs

since 2005


Complete, Creative Solutions for Rapid Diagnostic

Test Developers and Manufacturers


• 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 transfer

Assay Development Services


• DCN can develop and

commercialize all aspects of

a point of care diagnostics

platform, through our in-

house capabilities and our

Network of Affiliates

• Custom design and

integration for high

performance assays our

specialty

Integrated System Design and Development

Cartridge top housing

Desiccant

RF id tag

Cartridge bottom housingStrip and Assay


• 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 course

Education and Training Services


• 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.

Contract Manufacturing

Reagent Prep Area

Main Lab (Class 10,000 capable cleanroom)

Component Processing Area (Temperature / Humidity Controlled)


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

available


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 evaluation


DCN provides everything

needed to develop or

manufacture lateral flow

or flow through assays

Products


Products

High quality gold colloids

• 20nm, OD 1-10

• 40nm, OD 1-10


Products

Material and Reagent Kits

Material Starter Kit

Gold Conjugation Kit

Latex Conjugation Kit


Products

Lateral Flow Test Strip Readers

ESE (Qiagen)

LRE (Esterline)

Alverix

Axxin

Detekt

Skannex


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 suppliers


Sample collection and handling methods Device (cartridge) design

Biological recognition reagentsSignal generation

technologies

Manufacturing Process

Design

Assay Design and Components

DCN Provides User-Centric Design and

Development of Complete Assay Systems

Interpretation and signal transduction

technologies


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)

Lateral Flow Assay Development: DCN

Health & Medicine

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