Lyophilization and Diluents
With more than 30 percent of the FDA-approved parenteral drugs and a steady increase in injectables requiring lyophilization, the Fresenius Kabi Contract Manufacturing organization is dedicated to support both our new and existing partners‘ drug product portfolios. Our U.S. based state-of-the-art facilities offer lyophilization and sterile diluents for reconstitution in various containments and volumes.
Lyophilization, defined as the freeze-drying process of a liquid product after it is frozen and placed under a vacuum, has three interdependent processes; freezing, sublimation (primary drying), and desorption (secondary drying). The process simplifies aseptic product handling while enhancing the stability of the product in a dry state through the removal of water without excessive heat. Products with instability in solution are manufactured as a lyophilized form. There are a multitude of lyophilized product advantages including extended shelf life (typically two to five years) while maintaining drug potency, room temperature storage conditions and ease of transport due to the reduced weight and volume of the finished product.
As lyophilized drug products require diluent for reconstitution, Fresenius Kabi Contract Manufacturing is proud to provide sterile diluent to our partners in both injectable and vial formats through our plants in Wilson, Grand Island and Melrose Park.
We offer manufacture of diluents in 1 - 10 mL pre-filled syringes (PFS) and vials, as well as larger volumes upon request.
Choosing the right partner is critical to the success of your product development and commercialization. When your complex formulation cannot be sterile filtered or terminally sterilized, let our aseptic fill & finish, lyophilization, and sterile diluents (filled in PFS out of Wilson and vials filled out of Grand Island and Melrose Park) contract manufacturing services provide you with the solution.