Drug Product Process Development and Optimization

Want to discuss your process development and optimization challenges?

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.

This on-demand webinar focuses on the manufacturing aspects of amorphous spray-dried dispersions (SDDs) to enable successful scale-up and optimization of the process.

View our webinar on-demand

Manufacturing amorphous solid dispersions by spray-drying: scale-up approaches

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