Manufacturing, Lyophilization

The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.

A survey provides insight into drug companies' plans for spending on outsourced services. This article contains bonus online material.

Apply a DoE strategy to test several formulations in parallel.

A case study assesses freezing time and physical robustness under stress.

Genentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation.

Needle-free vaccine delivery platforms can solve the problems of stockpiling, cold-chain management, and pandemic preparedness.

The sugars used to stabilize lyophilized proteins often have not been subjected to appropriate cGMP standards.

by Thomas W. Patapoff and David E. Overcashier Genentech, Inc. The freezing method used during lyophilization can substantially affect the structure of the ice formed, the water-vapor flow during primary drying, and the quality of the final product. Controlling how a solution freezes can shorten lyophilization cycles and produce more stable formations.