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 contracts with global industry leaders such as Roche and Johnson & Johnson, Fleet Bioprocessing Ltd. are superbly qualified to fulfill 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 and UKCA; we will always be happy to advise on how their requirements may impact the custom development of your immunoassay product. Take a look at our blog post on the benefits of ISO13485 here.
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:
Example Projects
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.
Expansion of automated assay menu
Fleet assisted a multinational diagnostics company to fill in gaps in their product portfolio by developing a set of challenging assays. Fleet developed three assays for their automated chemiluminescent platform, sourcing suitable critical raw materials and integrating our own systems with the clients QMS. Assay performance studies were conducted according to CLSI guidelines, and conjugation methods were shown to robust for transfer to the clients manufacturing.
Development of a particle coating method and application to turbidimetric assay
Fleet developed a particle coating method to assist an established diagnostics company. Having used this method to immobilise antigen, Fleet went on to develop the coated beads into a full assay for the client, ready for claim support studies, and conducted investigations to demonstrate the robustness of the coating method. The Fleet method provides a platform for development of further assays, and we continue to support the customer with manufacture of the coated particles to GMP standards.