Formulation

Some example formulations (click to enlarge):

Some important considerations in formulation:

• Most formulations will be required to support at least one freeze thaw, even for drug products which are stored at 2-8° C.
• Proprietary formulations can be blocking for biosimilars—so early planning for formulation development is a must, even in biosimilar projects.
• Consider using an industry quality GMP logistics company to manage shipments for testing at outside labs—even early on.

Sandpiper Pharma can keep your project on track with state of the art formulation and stability study designs.