Lifecore’s analytical development team has broad experience with Compendial methods, transferring client developed test methods, and developing unique methods for assaying drug products and degradants.
Early phase clinical trial material (CTM) is tested and released by the analytical development team using validated sterility and endotoxin assays. A variety of other specialized assays using GC, HPLC, and rheometry are used to release the CTM. Later phase CTM is released by a complete set of validated methods.
Stability studies are an integral part of any development program. Lifecore has extensive experience running ICH-compliant stability studies for early to late stage drug product development programs over multiple years. This allows you to benefit from our knowledge and helps you alleviate unforeseen problems.