Services > Contract Manufacturing
Contract Manufacturing
DCN has established a full scale contract manufacturing facility at our core facility in Carlsbad, CA. Outfitted with a full range of highest quality manufacturing equipment from our technology partners at BioDot Inc, DCN has the flexibility and capacity to establish manufacturing jobs for our clients ranging from small scale prototyping and validation runs of a few thousand strips, all the way up to full scale manufacturing of millions of strips annually.
High Quality at reasonable cost
Located, as we are, close to San Diego and Sorrento Valley, with the highest density of skilled and experienced labor in the area of rapid test assembly anywhere in the world, and with low labor costs, we are in a unique position to produce high quality tests at exceptionally reasonable pricing in a first world environment. Our experience and expertise in dealing with US and international markets for human, veterinary, food science and agricultural assays, means that we always produce with a high degree of attention to the appropriate regulatory and market requirements.
Our production staff are continuously supported by technical and quality assurance personnel in order to ensure a consistently high level of product quality.
Transfer to manufacturing of existing product or newly developed product
DCN’s manufacturing capability is available both to our development customers and also to companies who are currently in manufacture at their own facility or at another outsourcing site. Our expert manufacturing transfer teams will work with you and your existing supplier 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.
Reducing assay variation on a manufacturing scale: Manufacturing quantitative or reader based assays is our specialty
The production of assays that require quantitation or are to be reader based requires a high degree of attention to detail in order to remove much of the inherent process, equipment and material – related variation evident in most lateral flow assays. Reduction in assay variation on a production scale relies on strict attention to the entire assay system, including:
- Assay design, manufacturing processes and equipment
- Careful material selection and treatment
- Development of treatments to overcome variation in materials
- Use of novel, custom designed materials where possible
- Use of appropriate, high quality manufacturing processes
- Use of high quality, reproducible sample collection and processing methods
- Use of alternative labels and reader technologies
- Use of alternative platform designs, such as flow through or hybrid platforms
DCN works with equipment suppliers such as BioDot, and high quality material suppliers such as Whatman, Millipore, Adhesives Research, and G&L to reduce the levels of inherent material and manufacturing process variation in the assays we design and build for our clients. We have many years of experience in dealing with difficult sample handling challenges, as well as in the formulation of high quality pad and membrane treatments, and in the design of high quality manufacturing processes. Our particular experience in developing many reader based fluorescent, visual and paramagnetic reader based assays has allowed us to develop strategies for the reduction of process level CV’s in lateral flow and flow through assays to levels appropriate to quantitative systems.