Process Development
Curia has expertise in first in human through commercial manufacturing, enabling support with all aspects of process development, optimization, and technology transfers.
Having an inefficient process can have significant consequences in later clinical and commercial stages. Poor product quality and higher than expected costs can create havoc on a drug development program. Recognizing that every drug product is unique, we take a customized approach when it comes to process development. During process development, we identify and optimize process conditions and parameters.
cGMP Process Design & Development:
- Stability during manufacturing
- Process scale up and optimization
- Material compatibility assessments
- Hold time studies
- Sterilization approach and process
Lipid Nanoparticles (LNP)
Curia supports the two main methods of LNP manufacture: T-mixing and Microfluidics. Our in-house microfluidics equipment includes Dolomite, Precision Nanosystems Blaze, and Precision Nanosystems GMP
Curia has expertise in formulation development to improve stability in addition to process development for manufacturing. Curia’s team of experts can assist in technology transfer of existing processes, development of a new process, or scale-up for first in human manufacture. We are investing in equipment and personnel, and are one of the few CDMOs with past projects already under our belt.
Curia’s Process Development Expertise:
- Sterile filtration
- Buffer characterization
- Aseptic fill/finish process development
- Temperature sensitive formulations
- Process scale up
- Engineering runs
- Mixing and dissolution
- Lyophilization