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 allow you to meet rigorous and more specialized product specifications. To meet these needs, our experts provide comprehensive process development to continually improve the operational efficiency in producing 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 scale-up from bench and pilot scale through to commercial manufacture under cGMP conditions. Our multidisciplinary product development teams are well versed in the interplay between:
- Material science and material design and functionality
- Product development and optimization
- GMP manufacturing requirements
- Process development and control
Reduce changes as your drug candidate advances
As our facilities, technologies and services can take a product from concept through to commercial development, process-development decisions, while phase-appropriate, can be made with the ultimate goal of commercial manufacture in mind. This approach streamlines the overall process and reduces the need for formulation and process changes as the drug candidate is advanced. A range of innovative process development tools and evaluations are utilized in our approach to process development and optimization:
- Computer-assisted process evaluation tools
- Scale-up and scale-down tools for specific unit operations
- Analytical method development supporting QA and QC activities
- Process analyses and troubleshooting to improve process efficiency
- Operational support to implement or maintain standards for cGMP compliance
- Process analytical tools to enhance process efficiency, productivity, and reliability
- Troubleshooting and resolving real-time production issues across a broad range of unit operations