Elemental impurities can arise from a variety of sources, such as active pharmaceutical ingredients (API), excipients, manufacturing equipment, and primary container closure systems.
Strategies companies can use to succeed in both advancing their candidates and attracting investors
Lipid-based drug delivery systems provide a reliable solution for poorly soluble molecules
Characterization of the micronized drug is important to understand its bulk properties and design downstream processes and manufacturing approaches.
The key to a successful tech transfer is for the vendor and the contract manufacturer to anticipate the challenges and come up with a game plan for the solutions to potential challenges.