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 ...

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 is essential for stabilizing biopharmaceuticals, but developing an efficient, robust process requires a clear understanding of the thermal transitions that govern product behavior. This ...

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 ...