Adams Gerald
Lyosolutions, Salisbury, Wiltshire, UK.
Methods Mol Biol. 2007;368:15-38. doi: 10.1007/978-1-59745-362-2_2.
This chapter provides an up-to-date overview of freeze-drying (lyophilization) with particulars relevance to stabilizing live cells or viruses for industrial applications as vaccines or seed culture. The chapter discusses the importance of formulation, cycle development, validation, and the need to satisfy pharmaceutical regulatory requirements necessary for the commercial exploitation of freeze-dried products.
本章提供了冷冻干燥（冻干）的最新概述，特别涉及为工业应用（如疫苗或种子培养）稳定活细胞或病毒。本章讨论了配方、工艺开发、验证的重要性，以及满足冷冻干燥产品商业开发所需的药品监管要求的必要性。
