Chemometrics

In order to maximize the amount of available information from a series of experimental studies, Legacy employs multivariate statistical techniques, commonly referred to as chemometrics. These sophisticated multivariate statistical tools not only facilitate our understanding of optimal formulation compositions, but they can also serve as valuable for solving manufacturing process challenges. In this context, we have performed retrospective assessments for determining the stability and quality of manufacturing processes over time and product consistency across different manufacturing sites. Legacy also has experience designing and executing design of experiment (DoE) studies, when indicated.

The application of formulation principles to the instability of proteins during manufacturing was covered in a review co-authored by Legacy scientists:

“Application of Formulation Principles to Stability Issues Encountered during Analysis, Processing and Manufacturing of Drug Substance and Drug Product Protein Therapeutics”, Samadhi Vitharana, Joshua M. Stillahn, Derrick S. Katayama, Charles S. Henry, and Mark Cornell Manning, J. Pharm. Sci. 2023, 112: 2724-2751.