Are you aware of another Bio product where warm manufacturing has been discussed and/or made a part of the contract. I foresee that at the end of the two year manufacturing cycle for the initial order, additional quantities and replenishment of expired shelf life product will be via warm manufacturing. It would be a cost effective vehicle for some of the SNS products where no everyday demand for a product exists. Similar to making C130's and Abrams to keep production going but not near the boondoggle they are!
Yes. For example in flu vaccine manufacture, there are commonly provisions made for unforeseen outbreaks or pandemic demand. However, I disagree that they would write-in warm manufacturing capacity as a matter of course because to the inherently prolonged period between campaigns. If you know your product is going to expire in three years, you can shut everything done and incrementally bring it back up as the date rises. On the other hand, it might be prudent to give SIGA a couple of million bucks a year to be somewhat prepared for a quick start-up in the event a real smallpox outbreak is actionably threatened or actually occurs.
Further, in my opinion what the US would need for such an event is a stockpile of any unique or 1) exotic raw materials or production reactors (actually rather unlikely) and 2) any time-consuming or prone-to-fail API intermediates-- as well as personnel with training maintained. I say this because if there were an outbreak of smallpox in New York, the US (after getting Ron’s family to safety, and provided with sandwiches) would could immediately begin flushing Viagra or Lipitor down the drain at some appropriately configured manufacturing plant and switch to ST-246 production. As long as they had materials and trained personnel.
My recollection is that there is a warm-base manufacturing component in the existing BARDA contract. However Sec. Sebelius got funding for government owned and operated pharmaceutical and vaccine manufacturing to rely less on contractors for production in an emergency. So this makes it more practical for contractors (who subcontract manufacturing) to warehouse API but not sequester production and packaging facilities. BARDA required Bavarian Nordic to build a vaccine manufacturing plant in the US for Imvamune, It was part of a warm-base contract for their smallpox vaccine.