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.