On commencement of a project, a development team will be appointed to work closely with you through the product feasibility and development process. We are extremely collaborative and welcome as much or as little customer input as you wish. We provide regular reports during the process and welcome customer audits.

DCN’s product design strategy is compatible with US and international regulation in numerous industry segments. DCN is ISO 9000-2001 certified and operates its development program under Design Control procedures.

Design Input Phase

We work with you to generate the assay specifications and determine your exact needs from the process. A design input document is created and a workplan and proposal are created for the first phase, Feasibility and Prototyping. This proposal will include a resource evaluation for the project, the proposed workplan, timeline and cost.

Feasibility and Prototyping

This phase involves the development of working prototypes and the determination of the functional characteristics of the assay relative to the design inputs created in the Design Input Phase. The assay will be optimized and the performance of the reagents assessed in terms of analytical sensitivity, specificity, cross reactivity, and stability (accelerated). Limited clinical studies will be performed. At the end of this Phase, a set of prototypes will be generated and given to the client for assessment, along with a full report and a set of SOPs used for production of the prototypes. At the end of this phase, the client can choose to complete development themselves or move into the Development Phase with DCN.

Development Phase

In this phase, the prototype product will be optimized in the best industrial conditions, taking cost and manufacturability into consideration. Integration of other assay components will occur during this phase, including cassettes (novel or off the shelf), sample handling and delivery elements, and reader systems. We will work with our partner companies to provide any required assay system components and manage those aspects of the project so that our clients need only deal with a single source supplier for all elements – DCN.  At the end of this phase, assay performance will be verified and the design will be frozen. A complete Device History File will be delivered along with devices for performance verification studies.

Validation, Scale Up and Manufacturing Transfer

In this phase, the assay will be scaled up, manufacturing processes defined and validated, and manufacturing transfer activities will begin. A full set of validated manufacturing SOPs will be produced and the assay will be transferred to production. At the end of this phase, the validation lots of product will be produced and all development documentation will be completed. Upon completion of validation, the assay will enter production.

CONSULTANTS: You can join our network of providers. To join, simply email us at info@dcndx.com and we will contact you to begin the process.

Click here to access the details of our consulting services including the biographies and resumes of some of our key consultants.

You can see our partner companies’ listings here.

Consulting Services Offered Include:

• Regulatory affairs
• Quality system design and establishment
• Technology Evaluation
• Board level advice
• Market evaluation
• Product troubleshooting
• Manufacturing process scale up
• Equipment selection and facility design
• Device design
• Due diligence for diagnostic technologies
• Technical audits
• Intellectual property landscaping
• Risk analysis
• Manufacturing capability audits
• Project planning
• Project management
• Technology development assistance
• Manufacturing process design
• Commercialization assistance
• Assay troubleshooting
• Facility setup
• Equipment requirement definition
• Equipment procurement

Services are typically provided for groups including:

• Start ups
• Companies developing products for the rapid assay sectors
• Companies acquiring new technologies
• Venture Capital (VC) groups
• Investors
• University or other higher education groups seeking to prove or commercialize new technologies
• Technology or platform developers
• Companies developing new components for point of care assays
  • Material suppliers
  • Reagent suppliers
  • Manufacturing equipment suppliers
  • Reader developers and manufacturers
  • Sample handling component suppliers

Manufacturing Transfer and Industrial Validation

This phase involves installation of the product at the manufacturing site, training of manufacturing personnel, validation of processes and product, and verification of the ability to reproduce performance lot by lot and run by run. This process is greatly simplified if manufacturing is to be performed by DCN, however, should the client choose to transfer manufacturing to another site, DCN will develop a plan with the customer and perform the transfer at the site of their choosing.

Manufacturing Services

DCN can transfer your assay internally to our manufacturing facility, where we will provide high quality ongoing manufacturing of the product at any volume level.

Troubleshooting and Follow up

DCN will continue to work with the client and their manufacturing group until the product is completely stabilized and in production. We are your partner in getting your product to market and will stay with you all the way. If we are your chosen manufacturing partner, we will work diligently to ensure the highest product quality, on time, every time.

Overview

Process

Custom Assay Development

We provide a phased approach to the product development cycle, and you can choose to utilize our services at any level. Just use us for feasibility and prototyping, or stay with us all the way to manufacturing and commercialization. We will custom design a program specifically for you.

Our Development Philosophy

We aim to deliver the highest possible performance in the shortest possible time, by focusing on all elements of the assay system from sample collection and handling to assay development, manufacturing process design, and assay interpretation. Our strategy of partnering with providers of high quality assay components, from strip materials to signal reagents and cassettes, manufacturing equipment, sample handling equipment, and readers, provides us with a unique ability to integrate all of the required elements of a high performance assay system for our clients. We can develop your strip, or we can develop an entire assay system for you.

Assay Formats and Sample Types

We work with any required format of lateral flow, flow through or microfluidic based immunoassay. We have broad experience with qualitative, semi quantitative and fully quantitative assays, based on gold, latex, fluorescence or magnetics.
Our team has developed assays for virtually every type of analyte in all conceivable matrices, and applications have ranged from human and animal diagnostics, to agriculture, forensics, biowarfare, food microbiology, aquaculture and environmental testing to name a few.

Process

Production

Conjugates can be optimized for:

• Protein – Colloidal gold
• Protein – Latex (fluorescent latex, colored latex, paramagnetic latex)
• Protein – Quantum dots
• Protein – Protein
• Protein – Small molecule
• Small molecule – particle

Our highly experienced chemistry and biology teams can apply any required strategy to the conjugation, including passive adsorption, covalent coupling or affinity coupling.

We partner with the suppliers of the highest quality particles in the industry to provide only the highest quality conjugates. You can supply your reagents or we can source reagents for you.

Complete Optimization and Quality Control

As well as optimizing your conjugate, on request DCN can completely optimize conjugate system of your assay and evaluate it for quality and performance in your complete system. We can usually develop binding assays to determine ligand binding efficiency and will optimize and prove performance of the conjugate to any degree that you require.

Conjugate Manufacturing and Manufacturing Transfer

DCN can scale your conjugation to manufacturing scale and transfer the procedure to you or we can manufacture the conjugate for you.

Contact Us for more infomation.

Our highly experienced audit and evaluation teams can approach a program from a variety of angles depending on the needs of the client. Services include:

• Technical audits
• Intellectual property landscaping
• Risk analysis
• Technology evaluation – development of proof of concept data
• Market evaluation
• Quality system evaluation
• Manufacturing capability audits

Follow up consulting services can include:

• Project planning
• Project management
• Quality system establishment
• Board level advice
• Technology development assistance
• Manufacturing process design
• Commercialization assistance

Services are typically provided for groups including:

• Companies acquiring new technologies
• Venture Capital (VC) groups
• Investors
• Technology or platform developers
• Companies developing new components for point of care assays
  • Material suppliers
  • Reagent suppliers
  • Manufacturing equipment suppliers
  • Reader developers and manufacturers
  • Sample handling component suppliers

See our Consulting Page  for more information on the types of expertise that DCN can provide and  Contact Us with any queries.

High performance, quantitative and reader based rapid assays often require integration of other device components for optimal performance. DCN can develop your entire assay system.
DCN can provide

• Design and prototyping of custom cassettes
• Design and development of sample collection and handling devices for samples including
  • Whole blood
  • Saliva
  • Food samples
  • Fecal material
  • Environmental samples
• Design and integration of readers (fluorescent, visual or magnetic)
• Project management services

 The SymBioSys™ Program

DCN has partnered with Symbient Product Development to launch the SymBioSys™ program, designed to assist our clients in the development and commercialization of integrated assays and custom plastic components. Click here for more details.

Technically unparalleled in rapid diagnostic product development

SymBioSys™ delivers OEM development services for high sensitivity, qualitative or quantitative rapid tests using the state of the art in labeling technologies, assay formats, cassette and sample handling device design, and reader technologies.

All the capabilities of a large diagnostic company in an OEM service provider

 SymBioSys™ delivers access to the critical expertise commonly found in a mature diagnostic company: regulatory, management, quality system implementation, risk analysis, manufacturing process development, equipment design, facility setup, human factors research, market research, branding and OEM manufacturing included.

Reader Integration

Data capture and quantification are becoming critical to high performance point of need assay systems. DCN works with a variety of reader suppliers to provide reader solutions for your assay.
DCN works with all of the key suppliers of reader systems, including ESE and LRE. DCN directly sells ESE’s line of fluorescent and visual handheld and benchtop readers for lateral flow assays in the USA, and we work with clients worldwide to integrate readers from all manufacturers into their assay systems.
Inquire for more information on this topic.
 See some of our available reader selection here.

Consulting

Additional support for system development programs is provided by our other key partners and DCN consultants:

• Regulatory affairs
• Market evaluation
• Quality system development and implementation

See our Consulting Page  for more details on how DCN can support your entire development and commercialization program

Case Study

A case study for the development of a complete diagnostic test system showing the interaction of DCN and its partners is shown here.

Overview

The education program provides all of the basic information and practical experience required to enter into lateral flow or flow through assay development and manufacturing, and can be customized to include elements valuable to sales, marketing, upper management or development planning staff. The program provides a detailed introduction to the principles and practices of rapid immunoassay development. The education course can also be customized to be practical or theoretical in format, and can focus on any aspect of the technology:  from conjugations of fluorescent latex, to a more general agenda on the development of high sensitivity quantitative assay systems, which are more complex to develop and manufacture than standard lateral flow systems.

WHO CAN BENEFIT?

Anyone requiring information about lateral flow, flow through or next generation, rapid Point Of care assays.  For Example:

• Companies new to the industry
• Companies training new R&D or manufacturing staff
• Development scientists, managers or manufacturing staff looking to improve their skills in development and manufacturing of LFIA’s
• Sales and marketing staff, requiring training on the technology and markets

PRACTICAL HANDS-ON TRAINING

The course is very hands-on. The client can choose to:

• Manufacture colloidal gold
• Perform gold and latex conjugations
• Manufacture an example rapid test
• Get hands-on experience with all of the equipment
• Bring their own reagents and perform conjugations and basic optimization of their assays

CUSTOMIZED TO YOUR REQUIREMENTS

We work with you before your course to set up an agenda that meets your exact needs. You can download a questionnaire here that you can send to us to tell us exactly what you want and we will respond with a custom designed agenda. Once you have filled out the questionnaire, please email it to info@dcndx.com

Inquire for more details.

High Quality at reasonable cost

DCN is located close to San Diego and Sorrento Valley which has the highest density of skilled and experienced labor in the area of rapid test assembly anywhere in the world.  Coupled with low labor costs, this means that we are in a unique position to produce high quality tests at exceptionally reasonable pricing in a first world environment.

Transfer to manufacturing of existing product or newly developed product

DCN’s manufacturing capability is available to our development customers and also to companies who are currently manufacturing at their own facility or at another outsourcing site. Our expert manufacturing transfer teams will work with you to transfer the manufacturing process to our facility, perform the appropriate validation program, and get you quickly back into production. If SOPs are not available, DCN will put a short development program into place and redevelop your assay before initiating production.

Most reagents transition very well from ELISA to rapid assay formats.  DCN has years of experience in performing these kinds of assay transitions, and will rapidly reformat and validate your assay.

 DCN can educate you on how to develop these assays for yourself, through our Education and Training Courses in Lateral Flow and Flow Through Technologies  so that for subsequent assays, you can perform the transition work yourself. We can also help you to establish your manufacturing facility for rapid assays or can manufacture them for you.

However you choose to approach the process, DCN can support you in rapidly converting your ELISA to a lateral flow or flow through assay and getting into production.