Controlled ice nucleation in the field of freeze-drying: Fundamentals and technology review

A technique for drying and storing a protein as a soluble composite thin film on the surface of an ultrafiltration membrane

“…Due to the requirement for refrigeration and high vacuum, lyophilization is expensive and requires highly specialized equipment. The freezing process is stochastic in nature and ice nucleation occurs at different times at different locations in material being frozen [16]. Many proteins are susceptible to stresses that develop due to the non-uniform nature of freezing [17].…”

The influence of residual water on the solid-state properties of freeze-dried fibrinogen

“…porosity, surface area, crystallinity) can be tuned by varying the freezing rate during the lyophilization process. Furthermore, the formulation itself plays an important role, such as different amount of added excipients [30,31].…”

Stability of buffer-free freeze-dried formulations: A feasibility study of a monoclonal antibody at high protein concentrations

“…Very long reconstitution times might seriously 92 impair the potency or usability of a lyophilized product [6,7,9,10]. 93 It is therefore necessary to examine ways of reducing reconstitution 94 time (by controlling ice nucleation, for example) [11][12][13]. Geidobler 95 et al showed that controlling ice nucleation during freeze-drying 96 could reduce reconstitution times by a factor of 2-3 for protein 97 concentrations up to 160 mg/mL [14].…”