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 ...
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.
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 ...
The general principle of lyophilization has hardly changed, but significant advances have occurred in process and product attribute understanding. Lyophilization is a well-established technique within ...
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 ...
LyoHUB, a university-industry center at Purdue whose goal is the efficiency, science and technology of freeze-drying in pharmaceuticals and other areas, is offering a new free online course and other ...
Researchers are advancing freeze-drying techniques to keep mRNA-lipid nanoparticles (mRNA-LNPs) potent at higher temperatures, reducing the need for ultra-cold storage. These optimized processes can ...