Food Safety Lateral Flow Strips Development

Creative Diagnostics - Food & Feed Analysis

Food Safety Lateral Flow Strips Development

CD's core expertise lies in the development and manufacturing of rapid lateral flow immunoassay for food analysis. Owing to this expertise, we offer a custom lateral flow assay development service that is tailored to your needs. Creative Diagnostics uses a comprehensive step-by-step quality-driven approach to food safety lateral flow test development. We are able to develop food safety assays for different sample matrices including tissue, urine, milk, honey and much more.

What you can expect from Creative Diagnostics

Faster development

For customers looking for complete food safety lateral flow assay development, a typical program will take from 6 to 12 months (assay specific), and follows our robust approach:

Superior technology

Our small molecule antibodies and conjugates are in over 50 million assays every year and set the industry standard for:
+ Stability
+ Reproducibility
+ Scalability

Expert support

We have over 10 years of experience developing qualitative, semi-quantitative and quantitative assays for use in food & feed analysis. We’ve completed over 200 projects so you can be confident that we have the know-how to achieve the best performance for your test.

Concept & Planning Phase

Discussions will be held concerning the market requirements, product specifications, component supply and regulatory considerations. The output of these discussions will result in the completion of a product development plan which will incorporate all the phases required to take the product through to manufacture and then commercial launch. If we are also developing a lateral flow reader for you, we will have these discussions in parallel.

Reagent Sourcing

Creative Diagnostics provide a full search for commercially available antibodies and antigens in order to fulfill rapid test development. FIND YOUR REAGENTS.
Sometimes reagents are not commercially available or sometimes clients prefer to have their own reagents. Therefore, we can help with the antibody and antigen custom production.
Custom Small Molecule Antigen Service
Custom anti-Small Molecules Monoclonal Antibody


Assay Feasibility

Assay Feasibility

A number of different parameters such as sensitivity will be evaluated during this first experimental stage of assay development. Creative Diagnostics will prepare a series of prototypes to be assessed against development goals at the end of these extensive studies.

Optimization & Characterization

The formulations, materials and processes used to make the working prototypes will then be optimized to ensure reproducibility. For example, the optimal quantity of capture antibody will be determined.
A number of parameters like sensitivity and specificity will be characterized to meet the customers’ demands.

Validation

Full verification and validation of manufacturing processes to ensure assay robustness. Following client approval of the final lateral flow assay design and specification, the assay is classed as having reached design freeze and no further modifications are made.

Manufacture

Creative Diagnostics offers automated lateral flow manufacturing with the capacity to manufacture millions of rapid tests annually. In close communication with our clients we will address the following in order to meet timescales:
Batch sizes and manufacturing forecasts to meet market launch and on-going requirements
Explore and plan packaging and labeling solutions
Establish a timetable for manufacturing deliverables
Make quality control data available where required
Seek client feedback throughout the process

Manufacturing of Quantitative Lateral Flow Assays

Owing to CD’s experience, we are able to offer routine manufacturing for both qualitative and quantitative assays.

Transferring manufacture of an existing assay

We provide manufacturing services for tests that have successfully completed a lateral flow assay development project or that are already in the market but are being manufactured elsewhere.

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