Preformulation Studies
Our preformulation studies aim to get your lead candidate into the clinic sooner, paving the way to being first in the market. Preformulation studies at Coriolis Pharma comprise developability assessment, preformulation screenings and other critical studies. Designed and executed by our team of experts, they derisk the drug development process, ultimately saving time and money in later phases of development.
Preformulation Studies Define the Path for Derisking Development
Conducting preformulation studies is an essential step in drug development that focuses on identifying suitable formulation conditions for a drug candidate before it enters more extensive clinical testing phases. These preformulation studies strive to determine the criticality of various environmental factors, such as pH, ionic strength and buffer species, and evaluate various combinations of excipients. Additionally, preformulation studies assess the sensitivity of the molecule to pharmaceutically relevant stress conditions, such as shaking, freeze-thawing and elevated temperatures.
During preformulation studies, our experts systematically screen a vast formulation space and comprehensively generate holistic drug product development data, including accelerated stability and forced formulation readouts. Preformulation studies enable the careful selection of lead formulations for subsequent stability studies and drug product development.
Coriolis offers these preformulation studies as platform services for monoclonal antibodies (mAbs) and customized services for other modalities, such as therapeutic proteins, peptides, nucleic acid therapeutics or viral vectors.
Preformulation Studies Generate Early Manufacturability Understandings
Biopharmaceutical compounds experience diverse stresses throughout the drug product development and production processes. Our analytical experience and expertise support selecting the most robust lead candidate for developability assessment against stress conditions relevant to production, formulation and storage. We generate knowledge related to the maximum and minimum active pharmaceutical ingredient concentration, the impact of filtration or pumping steps on a molecule’s stability and the most suitable storage temperatures.
mAbs Accelerator Platforms
Kick-start your program with our developability assessment and preformulation screening services. Leveraging our extensive scientific expertise, we’ve crafted these platforms to help you identify the optimal strategy from the outset and address potential stage-related risks.
Preformulation Studies for Your Drug Product
We design preformulation studies for many biopharmaceutical drug products, including highly concentrated protein formulations and active pharmaceutical ingredients like live virus vaccines and viral vectors that fall under biosafety level 2.
Your Phase
Coriolis designs preformulation studies to help you pick the best drug product candidate(s) and/or formulation design from the beginning of your program. This ultimately minimizes program failure risks, speeds up time to market and reduces costs.
Preformulation Studies Resources
Articles
Streamlining the Path to Approval with Developability and Pre-Formulation Platforms
July 18, 2024
Articles
Partnering with Scientific Excellence to Derisk and Accelerate Drug Development
July 15, 2024
Publications
Quantitative Laser Diffraction for Quantification of Protein Aggregates
January 1, 2019
