| 摘要 |
The present invention provides improved methods to lyophilize (freeze-dry) active ingredients such as proteins, nucleic acids and viruses. The present methods improve the degree of excipient crystallization during lyophilizatio n over prior methods. The improvement in excipient crystallization is based, i n part, on a high-temperature annealing step that is conducted prior to or at the same time as secondary drying. Importantly, the high~temperature anneali ng step does not destabilize active ingredients. Further, the high~temperature annealing step does not require sub-zero annealing steps prior to its enactment in order to provide complete excipient crystallization.
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