drug product process development and optimization

Get comprehensive development support

Meet rigorous product specifications and ensure efficient process intensification to optimize manufacturing costs. To meet these needs, our experts provide comprehensive drug process development to continually improve your operational efficiency.

Expert drug process development, optimization and validation

Access our expert drug process development, optimization and validation as part of our integrated services spanning feasibility studies, clinical trial manufacture and commercial production of drug substances, intermediates and finished drug products.

There is a need for drug-manufacturing processes that produce the next generation of innovative products. Now, more than ever, these processes must be innovative, efficient, reliable, and cost-effective allowing 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 and 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 commercial manufacture under cGMP conditions.

Our multidisciplinary product development teams are well versed in the interplay between:

• Material science / material design and functionality
• Product development and optimization
• GMP manufacturing requirements
• Process development and control
  
  

Streamline your process and reduce the need for changes as your drug candidate advances

Because we have the facilities, technologies and services to take a product from conception through commercial development, process-development decisions–while phase-appropriate–are 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