Preformulation studies are of fundamental importance in early drug development  for candidate selection and to support the development of a sufficiently stable formulation suitable for preclinical trials. Well designed and executed studies will save time and money in the long run by reducing the risk of failure in later stages.

In close collaboration with your discovery research, our scientists focus on characterizing the physico-chemical properties of the lead molecule(s) by employing low-volume and high-throughput method. During preformulation, we aim to determine the criticality of various environmental factors, such as pH, ionic strength, and buffer species, as well as the sensitivity of the lead molecule(s) to pharmaceutically relevant stress conditions, such as shaking, freeze-thawing and elevated temperatures. This wealth of information enables a rational selection of the most promising lead molecule(s) at early stage or the most stable formulation to enhance the success of preclinical trials. 

Developability assessment and the target product profile (TPP)

Results from preformulation studies are highly relevant to assess whether a lead molecule can be successfully developed into a drug product and will influence how the target product profile will look like. For example, results from preformulation may speak in favor of a lyophilized over a liquid formulation. In this case, we would suggest starting the development of a freeze-dried drug product in parallel to a liquid formulation development in order to provide a readily available fallback option.

An early understanding of the manufacturability

Biopharmaceutical compounds will experience a diverse array of stresses throughout the development and production process. Our know-how and analytical portfolio, of both traditional and cutting-edge analytical techniques, aid the selection of the most robust lead candidate against stress conditions relevant to production, formulation, and storage. We generate knowledge about the maximum and minimum drug substance concentration, the impact of filtration or pumping steps on the stability of a molecule, and the most suitable storage temperatures.

We design preformulation studies in close collaboration with you

We understand that material in early stages is precious and limited. Therefore, we set up preformulation studies to gain as much information as possible at a minimum material consumption. Our scientists will select a suitable set of analytical techniques and stress conditions to provide all relevant insights into your lead candidates. We also include initial formulation exercises to obtain a stable drug substance for preclinical trials. This way, we built a strong foundation for any subsequent drug development exercises and increase your chance of success.