Immunoassays For Clinical Diagnostics
In the competitive and highly-regulated field of clinical diagnostics - in vitro diagnostic (IVD) procedures for the analysis of human clinical samples – technical knowhow is not enough. It is also essential to understand the regulatory expectations for your product and the assay development process itself, and to maintain a keen awareness of the requirements for commercial success.
With experience gained “at the sharp end” of commercial product development and launch with global industry leaders such as Roche and Johnson & Johnson, Fleet Bioprocessing Ltd. are superbly qualified to fulfil these requirements.
Fleet employ a phased development process structured around regular design reviews – designed to meet the Design Control requirements of the US FDA and other regulatory agencies. We are compliant with ISO13485: 2016 and conversant with all other relevant regulatory standards such as IVDD/IVDR; we will always be happy to advise on how their requirements may impact the development of your immunoassay product.
A common pitfall in immunoassay development is a failure to clearly document all the requirements for a successful product – technical, commercial and regulatory. Fleet employ a standard documented approach to ensure that all these requirements are captured as design input for the development process.
We work with IVD customers ranging from global market leaders to academic researchers, spin-outs and SMEs. Smaller clients may need help to commercialise their technologies or perhaps to attract interest from larger companies. And larger companies, although they may have their own assay development groups, may wish to outsource development of certain menu items or seek external expertise on specific issues.
More details of how Fleet can help you throughout the phases of the immunoassay development process can be found on the following pages:
New range of 50+ allergy assays
Over a six year period, Fleet developed over 50 allergy assays for an automated chemiluminescent platform. Full claim support was performed at Fleet for all of these assays, and Fleet continues to support the customer post-launch with manufacture of critical reagents.
Novel cancer marker ELISA development - from start to finish:
A UK start-up had identified a novel biomarker for pancreatic cancer, and Fleet conducted development of the accompanying immunoassay. Claim support and stability trials were then performed at Fleet to allow CE marking and launch of the kit. Fleet went on to manufacture initial launch batches of the kit, and continues to support the assay with critical reagents.