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

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.

acheiving chemistry trifecta