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Lyophilization (freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products (> 400 FDA-approved); because absent water, the rates of degradative processes are reduced substantially. Essential to successful lyophilization, and subsequent rehydration, are use of proper containment and reconstitution systems.
These systems, and the components that comprise them, are discussed in detail in the chapter Container and Reconstitution Systems for Lyophilized Drug Products in Lyophilization of Pharmaceuticals and Biologicals (ISBN 978-1-4939-8927-0, Humana Press, 2019) by P. McAndrew (Dir., Scientific Communications), D. Hostetler (Sr. Manager, Integrated Solutions) and F. DeGrazio (VP, Scientific Affairs & Technical Services). This chapter discusses the fundamental chemistry and physics of the lyophilization process. It also discusses (a) influence of component designs (e.g., stopper vent, vial wall thickness, vial adapter spike), and the (b) influence of component materials (e.g., thermal conductivity, water adsorption) on performance. Understanding all these factors facilitates the selection of the right components for lyophilization drug packaging systems.
For more on how West can help with containment and reconstitution systems, contact an Account Manager or Technical Customer Support representative, or visit the Knowledge Center.
Some pharmaceutical substances, such as proteins, monoclonal antibodies, enzymes, and vaccines, are unstable in solution. They can degrade, for example by enzymatic or hydrolytic reactions. Lyophilization (also called freeze-drying) is the most common approach to address this.* Lyophilization is the process of dehydrating a material at low temperature and reduced pressure. Absent water, the rates of degradative enzymatic/hydrolytic processes are reduced substantially, and thus drug product stability is improved.
Lyophilization is widely used for pharmaceuticals to help preserve parenteral drugs that are unstable in liquid formulation, particularly biologics. Lyophilized drugs have many advantages like prolonged shelf life, easy dissolution and good stability. However, a suitable container closure system is necessary to ensure the successful lyophilization of pharmaceutical products while maintaining product quality.
Many injectable drug products, such as monoclonal antibodies and recombinant proteins, are susceptible to degradation over time when stored at ambient temperature. As such, they are stored, and subsequently delivered, in a lyophilized state - which enables a much longer shelf life. Lyophilization (also known as <em>freeze-drying</em>) is a process by which all water is removed from a drug product. Absent water, all metabolic processes stop, and drug products thus stored in a lyophilized condition are far more stable. At the time of use, the lyophilized drug product is reconstituted with water (or other appropriate solution) and delivered to the patient.
Lyophilization removes water from a drug product through three phases: freezing, primary drying or sublimation, and secondary drying or desorption. To begin the process, the drug product is frozen and then placed under a vacuum, which allows the ice to change from solid to vapor without passing through a liquid phase.
Many parenteral drug products, such as monoclonal antibodies, are susceptible to degradation over time. To enable a longer shelf life, such drugs are often stored in a lyophilized state. Lyophilization (<em>freeze-drying</em>) is a process by which water is removed from a drug product. In the absence of water, all metabolic processes stop, making lyophilized drug products far more stable.
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