Hi ahjay,No it doesn't mean IMM are responsible for manufacture...

Hi ahjay,

No it doesn't mean IMM are responsible for manufacture until patent expiry. I expect there will be many patents on this which may include, the drug, mode of action, delivery mechanism, manufacturing processes that may be unique & novel. These patents protect the inventor (IMM) and allow them to recover discovery and research costs prior to generics being allowed in. To purchase this would cost big pharma a huge amount especially if (hopefully) phase IIb data is good.
Scaling up to 2000L in the new one use reactors is good. You can use many reactors at this size and it presents easier and less validation than larger multi use reactors. You eradicate the need for cleaning validation as there is no x contamination issues to worry about. Ultimately easier to get regulatory approvals for market.
The next big issue is marketing the drug and they may work in collaboration with big pharma to market the drug. The indications are that product manufacture will be in-house using the Chinese contractor. Beyond that is conjecture on my part.