The profitability of a lyophilized product begins with the development of the formulation, not at the start of manufacturing. This is the first part of a two-part article. Part 2 is also available for on-line viewing. After about a week of storage, it must be discarded. However, if the kinetic clock for degradation of the vaccine could be slowed so that 1 second was extended to 1 hour, then the useful life of the formulation would be increased to almost 20 years.
Lyophilization stabilizes the formulation by slowing the kinetic clock of the degradation process.
It alters the clock by removing the solvent component or components to levels that no longer support chemical reactions or biological growth. This removal is accomplished, first, by freezing the formulation, that is, separating the solutes from the solvent or solvents and immobilizing any solvent in the interstitial region between the solvent crystals. Time, shelf temperature, and chamber pressure to conduct primary and secondary drying. The nature of the container system. Design and construction of the freeze-drying equipment.