Preformulation studies

developability

Converting a lead molecule into a drug candidate

Converting a lead molecule into a drug candidate during preformulation

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 By utilizing cutting-edge analytical techniques, we generate a basic understanding about which of the lead molecules from the discovery phase are most robust against stress conditions relevant to production, formulation, and storage. For example, the knowledge about maximum and minimum drug substance concentration, the impact of filtration or pumping steps on the stability of a molecule, or the identification of suitable storage temperatures is very valuable d

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.

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Preformulation studies tailored to your drug substance

We offer preformulation studies for the following product types backed by many years of experience with similar drug substances. This service will be tailored to your specific needs and aligned to your discovery phase strategy. Click on a product type to explore our entire portfolio of specialized research and development, as well as analytical services.

Quality & biosafety level of this service

We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:

Our know-how related to preformulation

Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars:

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Our other services

Coriolis provides a wide range of science-driven and tailor-made solutions for research, development, and analytical challenges. Explore our other services and learn more about how we can support your drug development program. Together, we can make future therapies available to patients and improve the quality of life for humankind.

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Please contact Dr. Matthias Lucke for inquiries related to preformulation studies

Dr. Matthias Lucke