Process Chemistry
Process Chemistry Services
During API chemical development, there are three words that every partner is focused on: quality, speed and cost. Although chemical reactions may work perfectly on lab scale, moving from milligrams to kilograms or tons is not a simple, linear process. Working as an extension of your team, Pharmaron’s process R&D experts can help you develop scalable, safe, robust, cost-effective and ‘green’ processes for the manufacture of your preclinical, clinical and commercial API supplies. We have experience with a wide range of services for API development from lead optimization to IND through to NDA filings. We perform route scouting, design, optimization and process safety studies to deliver high-quality preclinical, clinical and commercial API supplies efficiently and on time.
Learn more: Enabling Technology
Capabilities
Process Chemistry R&D Capabilities
- New route design/existing route redesign for both clinical and commercial supply
- Integrated crystallization design, salt screening and polymorph studies (Material Science)
- Compound purification and isolation improvements
- Fit-for-purpose optimization of chemical reactions
- Cost-effective, safe, sustainable process design & optimization
- Process safety assessment and control
Process Chemistry R&D Capabilities
- High throughput experimentation for optimization of reactions using enzymatic and new catalyst systems development and safety control using flow chemistry
- Application of DoE and modeling tools to inform on process design
- Process validation for late-stage clinical APIs and for registration batches going into regulatory submission
- Scale-up for preclinical/early-phase clinical studies
- Commercial production of intermediates and APIs
China-UK-US Hybrid Model
- Hybrid model leverages our teams in China, US and the UK
- Provides integrated process development and manufacturing capabilities to rapidly accelerate API development
- Lean, efficient and fast problem-solving
- Flexible, cost-effective solutions tailored to your project needs
- Systematic and dynamic knowledge transfer
- Integrated project management including all logistical aspects
Achieving the Chemistry Trifecta
Learn how Pharmaron implements efficiency, safety and sustainability across chemistry projects.
