Process Research
& Development

A multidisciplinary process development team undertakes phase-appropriate process R&D for customer molecules in the drug development stage. We address the key elements of route scouting, process optimization, process safety evaluation, HAZOP studies, backward integration and scalability, to deliver processes that are robust, safe, reliable and scalable. Our team also conducts salt screening and polymorph evaluation in the very early stages of process development. Principles of phase-appropriate development and quality by design (QbD) are optimally used to support customer projects. We leverage our technical strength, analytical expertise and regulatory knowledge, to design and execute development strategies.

Our advanced process engineering and safety laboratories undertake process simulation with miniature lab reactors and associated engineering tools. Process safety parameters are evaluated using reaction calorimeter (RC1e), accelerating rate calorimeter (ARC), differential scanning calorimeter (DSC), thermal screening unit (TSU) and rapid screening unit (RSD). Our process safety engineers analyze experimental data to prepare a chemical hazard evaluation summary, ensuring that safety and compliance issues are addressed during the scale-up activities at the kilo lab and pilot plant stage. Our facilities are also designed to handle HPAPIs up to kilo scale.

80+ analytical chemists support process research and development activities with speed and quality. Chemistry experts work with the analytical team to ensure all relevant impurities are characterized, identified and isolated to meet regulatory filing requirements. We also synthesize and certify these impurities as reference standards. Key analytical activities involved in the process research and development stage are:

  • Development and validation of analytical methods and their documentation
  • Reference standard qualification
  • Release testing of drug substance and intermediates
  • Stability studies as per ICH Q1R2 for NCEs