Services > Contract Assay Development > Process
Assay Development Process
Process
The Development Process
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 project design strategy is compatible with US and international regulation in numerous industry segments. The outline is shown below. A detailed planning outline of inputs and outputs for each phase can be supplied on request.
Summary
| Phase | Phase Objectives | Output |
|---|---|---|
0 |
Entry into design processDefinition of objectives; resource evaluation; patent study if required; proposal of workplan, timelines and costs |
Completion of specification sheet and Feasibility and Prototyping Proposal |
1 |
Feasibility and Prototyping Study.Development of working prototypes and determination of functional characteristics relative to Specifications set in Phase 0 |
Completion of study; delivery of report and prototypes (if successful). |
2 |
Development, optimization and validation.Industrial scale-up |
Report SOPs Completed assay samples |
3 |
Manufacturing Transfer and Industrial ValidationInstallation of product at manufacturing site. Training of manufacturing personnel. Validation of processes and product. Verification of ability to reproduce performance lot by lot and run by run. |
Functional manufacturing process First lot of manufactured product |
4 |
Field StudiesVerification and validation of product performance in field conditions. Launch preparation |
Customer defined |
5 |
Launch follow upTroubleshooting and manufacturing support. |
Customer defined |
Design Input Phase
The first step in the process is the definition of project objectives. 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. If the client wishes to move forward, DCN will produce a Risk Analysis document for the product development phase, and generate a full proposal for complete product development to commercialization.
Development Phase
In this phase, the prototype product developed to date will be optimized in the best industrial conditions, taking cost and manufacturability into consideration. The assay performance will be validated, and the manufacturing process will be defined, validated and scaled up. 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, a complete Device History File will be delivered, along with a full set of validated manufacturing SOPs. Entry into the manufacturing transfer phase is the next step.