With a properly-executed assay development and transfer roadmap and careful attention to process and raw material robustness, you can expect smooth, predictable batch-to-batch performance from your product – and an easy life for your colleagues in Production and QC!
However it is unrealistic to expect that post-launch issues will never be encountered – raw materials (especially those from limited biological sources such as serum and plasma) may still generate surprise batch-to-batch effects, newly-encountered aberrant patient samples can challenge claim support conclusions, and – in the long term - customer and regulatory expectations may change from those agreed at the start of assay development.
Or you may have a “legacy” product which was developed without full attention to the factors noted above.
Fleet’s experts have decades of experience supporting world-class commercial assays, dealing with customer complaints and troubleshooting technical issues – invaluable know-how when things are not going smoothly. We will always try to help get things back on track, whether this needs specific redevelopment of an individual reagent or procedure, or the full development of a “Mark II” product to fix performance shortcomings or to meet changed regulatory expectations.
Flexible GMP manufacturing approach handles post-launch raw material changes.
Fleet regularly manufacture a range of 50+ allergen-biotin conjugates. Some of the allergen raw materials can be quite variable in terms of concentration and purity, requiring a careful production approach which combines flexibility with GMP control standards.
Improved calibrator stability demonstrated in Fleet study
A global diagnostics company suffered stability issues with the calibrators supplied to customers for a number of their assays, requiring them to be presented lyophilised or frozen rather than ready-to-use. Based on our own knowhow and an extensive literature review, Fleet conducted a comprehensive reformulation study which (for all the assays examined) identified alternative matrices and/or protective additives offering significantly improved stability over the current commercial reagents.
Fleet manufacture initial commercial batches for cancer ELISA
Having developed the ELISA for a UK startup, Fleet acted as manufacturer for claim support batches of the kit and continued to manufacture the initial batches following CE marking and launch.