While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed. The ...
SMi Group reports: Alina Alexeenko of Purdue University presenting LyoHub's overview and strategies for the future of lyophilization and alternatives to conventional methods Optimization of ...
Lyophilization, also referred to as freeze-drying, is a complex process that removes water from the drug product to preserve the product’s chemical and physical integrity. In this blog, we will ...
Approximately one-third of the unique biologicals in the FDA’s purple book are lyophilized, according to a recent paper. That includes (in 2020) nearly a quarter of monoclonal antibodies. Trends ...
Freeze drying is essential for stabilizing biopharmaceuticals, but developing an efficient, robust process requires a clear understanding of the thermal transitions that govern product behavior. This ...
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.
Freeze-drying, or lyophilization, is the principal method for converting heat-sensitive pharmaceuticals into stable, dry solids by sublimating ice from a frozen matrix under vacuum. Optimization of ...
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) ...
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 ...
Setting up in-house lyophilization capabilities and operations is an expensive and time-consuming process, which requires specialized lyophilization equipment and expertise. Considering the high ...