Developing an effective lyophilization cycle is both art and science.
Our skilled and experienced team of professionals, using Millrock lyophilization technology, provide critical and scalable synergies between the development lab and manufacturing line, ensuring your outcomes are met with the highest quality and always on time.
Pii will de-risk the product development process by conducting experiments at an R&D scale using our 8 square foot Millrock lyophilizer.
During the development of the lyophilization cycle or when optimizing a known lyophilization cycle, the understanding of thermal and physical characteristics is essential as no two products are alike.
Our scientists will study the thermal characteristics of the product and processes, with a particular focus on critical process parameters such as freezing point and eutectic temperatures, allowing us to bridge the product's physical properties through the use of Modulated Differential Scanning Calorimetry and Scanning Electron Microscopy.
We will also evaluate chemical and stability characteristics, focusing on reconstitution time, moisture content, assay, degradation products or impurities amongst the other critical quality attributes.
Lyophilization cycles can last from hours to several days, and to ensure a robust cycle that delivers a quality product profile in the most cost efficient manner is critical.
During cGMP manufacturing, the parameters established during development are verified. Our M and O Perry line will aseptically fill washed and depyrogenated vials, ranging from 3ml to 50ml, and partially stopper them.
These vials will be loaded into a 60-Square Foot Millrock lyophilizer, which, houses 6 shelves, with 4 trays being accommodated per shelf. Depending on the vial size, this cGMP lyophilizer can support batch sizes up to 20,000 vials.
Lyophilized vials will be capped and visually inspected to evaluate cosmetic and critical defects. Vials that successfully pass inspection will be proceed with the next stages, including analytical testing.
If you are challenged with a promising formulation presenting stability problems, freeze-drying may be the solution.