The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers. Lyophilization or freeze drying of injectable pharmaceuticals is a well-established ...

Lyophilization is a complex operation used to prepare stable pharmaceutical and biopharmaceutical products through freeze-drying. During lyophilization, the water fraction of the product is reduced to ...

Freeze drying, lyophilization, and cryodesiccation are all terms used to describe the process of removing water from a sample at low temperature. This low-temperature dehydration process maximizes ...

UMass Lowell has opened a state-of-the-art lyophilization facility that will help drive innovation and discovery in biopharmaceutical manufacturing in New England and beyond. Called the Lyophilization ...

Technical advances in process understanding and control must be accompanied by a change in mindset. Since its introduction to the pharmaceutical industry in the 1940s, lyophilization (freeze-drying) ...

Lyophilization is emerging as an effective way to prolong the shelf-life of biologics and to ease their refrigeration requirements, but its process development often requires multiple experiments.