- Corealis Pharma and PhinC Group have entered a strategic collaboration to integrate physiologically based biopharmaceutics modeling (PBBM) and physiologically based pharmacokinetic (PBPK) modeling into oral solid dosage form development.
- The approach combines Corealis’ formulation and manufacturing capabilities with PhinC’s predictive modeling expertise to assess formulation factors such as release rate, solubility, particle size and food effects earlier in development.
Corealis Pharma and PhinC Group have announced a strategic collaboration to integrate PBBM and PBPK modeling directly into oral solid dosage form development. The companies said the approach is intended to provide earlier insight into how formulation properties may affect clinical performance, particularly for development-stage oral small-molecule programs.
The collaboration combines Corealis’ formulation and manufacturing expertise with PhinC’s predictive biopharmaceutics modeling capabilities. The companies said the approach can be applied to programs involving solubility limitations, release-profile optimization, food effects, formulation bridging and bioavailability uncertainty. API, formulation and dissolution data will be incorporated into PBBM and PBPK models to evaluate factors including release rate, solubility, particle size and food effects.
The modeling is intended to guide prototype development and formulation selection. For biotech companies, Corealis and PhinC said the approach has the potential to reduce experimental iterations, provide earlier insight into human performance, prioritize formulation risks and increase confidence before committing API, time and clinical resources.
“By integrating PhinC’s predictive modeling capabilities with Corealis’ formulation and manufacturing expertise, we can evaluate critical development questions earlier, focus resources on the most promising approaches, and help our clients advance toward the clinic with greater confidence, stronger scientific rationale and reduced development risk.”
David Leroux-Petersen, CEO of Corealis Pharma
Corealis is an oral solid dosage CDMO supporting pharmaceutical and biotechnology companies from early formulation development through GMP clinical manufacturing and clinical supply. PhinC specializes in model-informed drug development, including PBPK and PBBM, and applies drug, formulation and physiological data to predictive models to support development decision-making.
