Lyophilization also known as freeze-drying is a process of isolating a solid substance from solution by freezing the solution and evaporating under vacuum.
Optimizing lyophilization cycle times and improving stability for complex injectables is a critical component of parenteral product development.
The process of freeze-drying injectable drugs stabilizes compounds so they can be reconstituted just prior to administration. This process can protect biological activity, extend shelf life, and even increase dosing precision. It is also convenient for storage and transport of the product.
Dalton Pharma Services offers cGMP aseptic formulation, fill and lyophilization services to manufacture sterile lyophilized bulk APIs. We also offer QC support for your product development and manufacture.
We can tray-lyophilize small kilo batches of sterile APIs, which can then be filled into bulk sterile containers (bottles, bags or pouches). Alternatively, we can use the sterile powders produced in aseptic milling and powder filling processes.
Our technical experts can support lyophilization of small molecules, carbohydrates, proteins, peptides, antibodies, and nucleic acids; either bulk or vialed with expertise in formulation, cycle development and cGMP production.