Validation of a process, equipment and (usually) three batches of a pharmaceutical grade recombinant IGF-1/BP-3 product. In the case of the product being developed for ROP . . . Premiplex. Validation includes providing formulation evidence that the product is being produced within narrow margins of chemical ingredients time-after-time (each batch).
Look a the label copy of Iplex and it states now much volume and weight of ingredient is present in each vial. Typically, there has to be a significant percent of vials from each batch that must be tested to demonstrate that the vials at the beginning of the fill, in the middle of the fill and at the end of the fill are the same product within the limits of the specification on the label pasted on the outside of the vial.
Iplex is not dead . . . never has been. It just went out of production in the hands of INSM and they made no provision until last year for outlicensing for production purposes. Now it is in the hands of the Premacure consortium to produce a product for premies.
that is where our opinions differ.You are looking at it in one way- I am looking at in money terms.
Iplex is dead money. At least now the money and control is starting to move.
ps- I am( and others) are of the opinion that the time to produce is more about regulatory than anything else.