Transfer to Manufacturing
It is wrong to consider the transfer of reagent manufacturing processes, raw material tests, assay QC procedures, etc. to manufacturing as a separate phase following performance verification.
In fact, manufacturability and robustness to process and material variation will already have been under consideration since the early stages of assay optimisation – and processes in an advanced stage of development and documentation will have been used to generate the reagents supporting the performance verification studies. So in practice this phase runs in parallel with the assay development process, and manufacturability factors will have been taken into account in the design review outcomes.
With a background with industry leaders in process development such as Kodak and Johnson & Johnson, Fleet possess world-class expertise in achieving successful transfer of robust procedures into the factory while ensuring that the appropriate GMP standards are achieved.
The apparently simple concept of “the factory” can in fact be quite complex – Fleet often end up as long-term manufacturer of critical reagents such as conjugates, and may also act as the initial manufacturer for the complete immunoassay kit, right through to packing and assembly – in which case transfer happens within our own organisation.
Often however the processes we develop must be transferred either to the customer themselves, or to their selected OEM partner. Regardless of the specific manufacturing responsibilities, Fleet will ensure that formal transfer is effectively executed.
Key elements of the transfer process include the approval of a full set of GMP production and QC procedures, and full hands-on support during initial production runs by third parties.
Long-term Fleet supply of HRP conjugate for cancer ELISA
Fleet developed a Mab-HRP conjugate for a novel cancer marker ELISA. Whilst assay production was mainly transferred to a third party OEM, the customer chose to retain Fleet as the long-term conjugate supplier, and the method has now successfully undergone transfer to production at Fleet.
Manufacture of key reagents for cardiac assay
Fleet manufactured the performance verification and launch batches for a CE-marked cardiology ELISA, as well as the lyophilised reference standard stocks needed to support the product through its lifetime. The methods were developed by Fleet then transferred into GMP production at our own site.
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.