Experts in optimization and validation
Now, more than ever, there is a need for drug-manufacturing processes that produce the next generation of innovative products.
These processes must be innovative, efficient, reliable and cost-effective to meet rigorous and more specialized product specifications. To satisfy these needs, our experts provide comprehensive pharmaceutical process optimization and tailored development strategies. Through pharmaceutical process optimization, we continually improve operational efficiency to support the production of your drug products.
Select the optimal drug process with enabling technologies
Process development begins with selecting the optimal process and enabling technologies during product design and proceeds through each stage of development, including process optimization in pharmaceutical manufacturing and scale-up from bench and pilot scale through to commercial manufacture under cGMP conditions.
Our multidisciplinary product development teams excel in:
- Material science and material design and functionality
- Product development and pharmaceutical process optimization
- GMP manufacturing requirements
- Process development and control
Reduce changes as your drug candidate advances
Our facilities, technologies, and services support every stage of development, from concept to commercial production, allowing for pharmaceutical process optimization decisions that align with long-term manufacturing goals. This approach streamlines the overall process and reduces the need for formulation and process changes as the drug candidate is advanced.
We optimize pharmaceutical manufacturing and development using innovative tools and evaluations, including:
- Computer-assisted process evaluation tools
- Scale-up/scale-down tools for specific unit operations
- Analytical method development supporting QA and QC activities
- Process analyses and troubleshooting to improve process efficiency
- cGMP compliance support
- Process analytical tools for drug development workflow optimization
- Real-time production issue resolution