swg - no, that's not what I'm implying. I just don't know the actual arrangements for Peregrine regarding finishing/filling for Bavi.
My take, which I feel pretty confident about, is that they do their own finish/fill for all clinical supplies, and send the dose-ready product to the point-of-use location. I could be wrong as I do not have any facts to substantiate this one way or the other.
Doing finish/fill in small/medium scale (for research and clinical trials) can be accomplished with smaller footprint and less sophisticated equipment. End results and quality requirements are the same, but the low volume enables it to be executed using a variety of possible configurations.
However, when a product goes commercial (approved and sold in market), the finish/fill part of the process is where it all comes together for the health care provider and/or patient, requiring all the components (label, inserts, packaging, etc.) that are not required for research or clinical use.
Regarding the fill being trivial - it's not. The purity and cleanliness of the environment, dosage/fill accuracy, tight controls of every little detail, etc. are very challenging. For standard pharmaceutical product (pills, etc. considered small molecule) the finish is even more complicated. Mainly because of the complexity of mixing all active and inactive ingredients, forming of the product dosage (pills, capsules, etc.) and maintaining the output with nearly zero variability.
It gets done. But generates untold headaches to the folks in charge and requiring infinite vigilance.
Best,
MH
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