The solution is frozen first, then the pressure is lowered so that the ice sublimes — passing directly from solid to vapour without melting. A secondary drying stage removes the water that remains bound to the molecule.
Freezing first is what preserves the structure. Drying a liquid concentrates everything in it as the volume falls, which is exactly the condition under which proteins aggregate; subliming from a solid avoids ever passing through that state.
A good lyophilised cake is uniform and occupies roughly the volume it did when frozen. A collapsed or shrunken cake suggests the material warmed above its collapse temperature during drying, which can mean more residual moisture than intended.
This is worth a look when a vial is opened. It is not a substitute for a certificate, but it is free information.
Lyophilised material tolerates a transit excursion that a reconstituted solution would not, which is why everything ships dry and is reconstituted at the point of use.
Once water is added, the clock starts: hydrolysis becomes possible again, and for a folded protein such as somatropin so does aggregation. Reconstituted material is refrigerated, kept out of light and not repeatedly warmed.
The solution is frozen first, then the pressure is lowered so that the ice sublimes — passing directly from solid to vapour without melting. A secondary drying stage removes the water that remains bound to the molecule.
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