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 ...

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 ...

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

Controlled nucleation is essential for obtaining high-quality lyophilized products with intra- and inter-batch consistency. Two approaches to achieving controlled nucleation have been investigated ...

This webinar will cover optimized, scientifically based lyophilization cycle development for pharmaceutical, diagnostic, and food products. It will include a discussion on the thermal properties of ...

Lyophilization, or freeze-drying, is essential in biopharmaceutical production but presents significant challenges, such as long timelines, high prices, and ...

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 widely recognized as an effective method for increasing the shelf life of labile drugs, including small molecule compounds and biotherapeutics. Of the top 100 drugs, ~16% are ...