drug product process development and optimization

We provide 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.

We recognize the need for drug-manufacturing processes that produce the next generation of innovative products. Now, more than ever, these processes must be efficient, reliable, and cost-effective allowing you to meet rigorous product specifications, contend with competitors and stretch ever-tightening budgets.  To meet these needs, our experts provide comprehensive process development, support, and training to help you improve your operational efficiency.

Process development and optimization expertise

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
• Process development and control
• GMP manufacturing requirements

Because we have the facilities and technologies 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
• Process analyses and troubleshooting to improve process efficiency 
• Troubleshooting and resolving real-time production issues across a broad range of unit operations 
• Process analytical tools to enhance process efficiency, productivity, and reliability
• Operational support to implement or maintain standards for cGMP compliance 
• Analytical method development supporting QA and QC activities