Formulation Development
Formulation Development
You need a plan to efficiently enable your drug's bioavailability, at the right rate, and ensure the compound is stable with a scale-able process to move through clinical trials to commercial launch. WuXi STA formulation development team is led by industry veterans with years of large pharma experience developing solutions for a wide range of molecules. The team has tackled challenges from solubility issues, excipient incompatibility, vehicle stability, to controlled release and much more. Our teams will customize our diverse expertise to guide you to optimal formulation suitable for scale-up to help you reach patients fast and cost-effectively.
WuXi STA's formulation evolution takes advantage of data available at each stage to steer the final drug product development. Adding to the data gathered in early developability assessment we can further mine clinical data to continually improve your drug's efficacy in the target populations. Our in vivo modeling and streamlined Quality by Design (QbD) process balances risk assessment, milestone targets and investment planning to achieve the most efficient scale-up for your business model and incoming data.
Early stage - Developability and Formulation Research (DFR)
Our DFR services provide all essentials for evaluating your lead and efficiently moving towards IND and Phase I clinical trials. We have extensive experience handling a wide range of compounds and challenges, a team of 1,192 formulators and analytical scientists, 1,704 pre-formulation molecules evaluated in 2021H1 and 275 formulations developed in 2021H1.
Our preformulation services include:
· Drug developability assessment
· Physical-chemical characterization
· Early physical form screening
· Pre-clinical formulation & drug delivery
Fast formulation with the goal in mind
Our teams have experience to guide your candidate to the next stage of clinic and market with optimized processes for scale-up, with our GMP development and manufacturing. Our 23,000+ sq.ft GMP facility in Shanghai has been inspected by the US FDA, NMPA and MPA. Our formulation development teams have comprehensive technology platforms for oral solid and liquid dosage forms including:
Oral dosage technology
Capabilities include
- Dry blend
- Roller compaction
- Wet granulation (high-shear & fluid bed)
- Compression (conventional, bilayer and mini tablets)
- Film coating
- Pelletization (extrusion-spheronization)
- Tablet, capsules and pediatric dosage form development
- Clinical trial material manufacture
- Registration stability batches
- Stability evaluation
- Process optimization and validation
- In-process critical control strategies
- Scale-up to commercial
