As the number of new molecular entities coming out of discovery exhibit developability challenges, developers are looking for ways to predict and overcome potential issues. During preclinical research, important distinctive tools are those capable of improving early phase decisions. These include selecting the best form among several promising candidates, solid state chemistry, human drug metabolism and pharmacokinetic (DMPK) predictability, and formulation technology to enhance bioavailability. Catalent’s highly experienced and specialized drug development teams enlist an integrated suite of tools to take the guess work out of evaluating risks and help you make informed data-driven decisions as candidate’s transition from discovery to development.
Catalent bridges the gap between discovery and development to reduce risks and determine potential obstacles before making big investments in later development stages.
During the early phases, understanding a molecule’s shortcomings and applying the right formulation technology can be the key to success. Using our 30+ years of experience, along with our established industry practices and data to drive recommendations, we evaluate the unique physiochemical properties and challenges of your molecule. Catalent can help predict human exposure based on in vitro and in silico data by applying:
- Developability Classification System (DCS)
- PB/PK modeling
- Parameter sensitive analysis on solubility
- Permeability and particle size
- Potential food effect
- Drug disposition
- Clearance of the molecule
Coupling formulation science with DMPK modeling, Catalent’s scientific advisors assess the developability of your molecule and interpret preliminary discovery and preclinical data. As your partner, we also will advise where additional studies are needed and recommend the most formulation pathway to reach first proof of activity in animal, GLP-compliant toxicology and PK studies, and ultimately, first-in-human clinical studies.
Catalent has established a team of committed scientific advisors to help you in analyzing molecule challenges you may face during early drug development
Every year, thousands of drug candidates are abandoned due to poor solubility and an inability to show exposure in animal models. Formulation can profoundly impact drug release, absorption, and metabolism, which influence the resulting PK profile and the associated PD response. Late stage discovery and preclinical formulations enable meaningful efficacy by maximizing exposure with minimal material usage, improving a molecules chance of becoming a viable drug candidate.
Visit Catalent.com/optiformselect to learn more about Catalent’s preclinical formulation services.