Freeze drying is widely used in the pharmaceutical industry to stabilize drug products. During freeze-drying, solvent is removed from a frozen product by sublimation to produce a dry product that can be readily reconstituted to its original liquid formulation by the addition of solvent. The process prolongs shelf life of the product by inhibiting chemical and physical degradation pathways that occur in the presence of moisture.
Lyophilization, or freeze-drying, carne into prominence during the 1940s after early experiments in the mid 1930s at the University of Pennsylvania, when it was used to prolong the stability of blood plasma and treatments such as penicillin, allowing them to be shipped long distances without losing efficacy. The process has been a mainstay of the pharmaceutical industry ever since and has become essential to biopharmaceutical manufacturing, as treatments such as monoclonal antibodies assume greater importance. Currently, more than half of the injectable drugs sold have been lyophilized.
IMA life’s Fusion shelves incorporate proprietary brazing and welding technology to construct freeze dryer shelves that are lighter, stronger, thinner, flatter, and have improved heat transfer characteristics when compared to conventional designs.
The VERISEQ™ Ice Fog Nucleation process cuts production time by up to 30%, increases process control, and improves finished product attributes. The freeze drying method consists of three phases; freezing, sublimation, and desorption. The critical role of the freezing step has for years been overlooked. The freezing process determines the fundamental crystal structure that influences the drying rate for each unit.
IMA Life has assembled a team of diverse industry experts to provide our customers a worldwide assistance with product development, scale up and qualification.
To enhance this offering, IMA Life has built a development laboratory at the Tonawanda, NY manufacturing facility. IMA Life can now offer assistance with any or all of the following, for all customers worldwide.