Product Development
Our dedicated staff of product development scientists and technical service engineers provides deep industry expertise over a range of services from early formulation development through late-stage product and process optimization for commercial regulatory submission.
Comprehensive expertise in sterile injectable development
Our technical staff works to incorporate QbD principles into the product development process for sterile injectables. We are focused on proactively mitigating potential risks with product formulation, process, container closure system, and packaging prior to GMP manufacturing.
Modalities
- Small molecules, peptides, enzymes
- Biologics
- Schedule III-V controlled substances
- Lipid nanoparticles
Formulation Development and Optimization
- Liquid formulations
- Homogenization
- Microfluidization
- Rotary evaporation
- Lab scale lyophilization
Pilot-Scale Filling
- Engineering process DOE
- Breakpoint studies
- GMP-scale confirmatory manufacturing studies
On-site product development support
Product characterization and optimization
- Target product profile (TPP) development
- Quality by design (QbD) studies
- In-use stability studies
- Excipient screening
- Solubility studies
- Process material and component compatibility
- Container compatibility
- Formulation development
Science that scales, development that supports manufacturing
Ensure seamless technology transfer and efficient scale-up
- Process optimization
- Failure mode & effect analysis (FMEA) / risk assessment
- Technology Transfer