Formulation Development
Preclinical Formulation Development
- IV/oral liquid formulations for PK, pharmacology, and non-GLP tox studies
- Integration with internal drug discovery capabilities in Medchem, Biology, DMPK, and Toxicology
- Use up-to-date technologies to optimize preclinical formulations to support drug discovery programs
Technologies for Poorly Soluble Compounds
- SEDDS formulation
- Nanosuspension (wet media milling)
- Emulsion, microemulsion, lipid based complex and micelle formulation
- Solid Dispersions: micro-crystalline or amorphous form with carrier matrix
- Solubilizing Agents: cyclodextrins, surfactants, polar organic solvents
Early Phase Clinical Formulation
- Powder in Capsule (PIC)
- Powder in Bottle (PIB)
- Tablet
- Liquid formulation
Oral Solid Technologies
- Wet granulation (high shear, fluid bed, extrusion spheronization)
- Dry granulation (roller compaction)
- Nanosizing in solid dosage form
- Tabletting, hard shell and soft-gel capsulation
- 0.1-20 kg capacity (for SFDA studies and FDA studies)
Injectable Formulation Technologies
- Sterile fill-finish (terminal sterilization, filtration and sterile filling)
- Lyophilization (Lyostar II with SMART technology, and in-process sample extractor)
- Nanosizing technologies (Microfluidizer and Dyno-mill)
- Service Overview
- Discovery Chemistry
- Biology & Pharmacology
- DMPK / Exploratory Toxicology
- Biologics Discovery
- Biologics CMC
- Small Molecule CMC