FleetBioprocessing Case Studies (Assay)
The following examples are just a small selection of assay projects demonstrating how our deep experience of commercial assay design can be used to satisfy our customers' needs.
BiomarCaRE
Northern Europe Assay
Development of 2nd Generation Biomarker Assay
Investigation of Antibody Pairings
Development and verification of 2nd generation biomarker assay for CE marking
A French based company asked Fleet to develop an automation-ready assay for a second generation test to replace their previous assay. The 18 month study involved raw material investigation, prototype assay development and then full performance verification studies of the selected assay design vs. agreed product requirements documentation.
The project was broken down into four phases:
Phase 1: Product Requirements Definition.
Phase 2: Prototype Assay Development.
Phase 3: Assay Optimisation and Clinical Performance Verification.
Phase 4: Demonstration of Assay Robustness and Raw Material Supply Activities.
The resulting assay met all performance goals after close collaboration between scientists in both companies.
Investigation of antibody-pairings and assay development
Fleet conducted a 6 month investigation into already-sourced antibody pairs and then went on to develop ELISAs on behalf of a customer based in the UK
The investigations looked at the following questions:
- Is the biomarker capable of being measured in serum or plasma using ELISA methodology at performance levels consistent with the intended use?
- Have suitable antibodies, antigens etc. been identified, shown to work and be available in sufficient quantities from commercially-viable sources?
- Has the effectiveness of the assay been demonstrated using appropriate clinical sample panels?
- Can a prototype marker ELISA be developed effectively into a commercial quality ELISA kit, which functions effectively and robustly in a RUO setting, and/or undergo CE marking?
- Has the robustness of the manufacturing procedures and raw materials been adequately demonstrated to confirm that reliable production will be achievable?
The work was done on time and to the agreed budget and met all the customer requirements.
Northern Europe Assay investigation
Fleet were asked to investigate a single-marker ELISA which was suffering from poor dilutional recovery and calibration problems. The week-long study resulted in recommendations for resolving observed technical issues and follow-on work involved bulk purification of recombinant antigen.
BiomarCaRE
Fleet have contributed to the BiomarCaRE project as part of a thirty-strong consortium funded by an EC Framework 7 grant to identify novel cardiac risk prediction biomarkers. Fleet were chosen as a UK-based SME due to our expertise in developing novel immunoassays in early stage studies.
The work has involved the identification of antigens and antibodies for novel markers and transfer to consortium partners for case cohort testing. One test has already been used to analyse a case cohort of over 10,000 patient samples.