Identify molecular liabilities and/or select optimal lead molecule
The aim of formulatability studies is to identify molecular liabilities, in conjunction with in silico modeling, that can negatively affect drug product stability or quality during the drug product’s lifetime, from manufacturing to administration to the patient. This information can be extremely valuable for selecting the optimal lead molecule from among a panel of potential molecule candidates or variants. It is also essential for selecting the appropriate drug product development strategy, including tailoring formulation development studies to address the molecule’s specific shortcomings, thus ensuring its clinical and commercial success.
Our Drug Product Services (Lonza DPS) team has a wide experience in performing and evaluating formulatability studies, to identify/flag potential development risks, and provide means to mitigate those risks.
The panel of in-vitro formulatability studies typically includes:
- Assessment of chemical liabilities, such as deamidation, oxidation, fragmentation, glycation
- Assessment of biophysical characteristics, such as isoelectric point (pI) and hydrophobicity, as well as colloidal and thermal behavior as a function of formulation conditions and assessment of liabilities to physical stresses
- Assessment of rheological properties, particularly in case a high concentration formulation is required