Muridda fully understands the importance of analytical support for process R&D and production.The Process R&D Department is committed to developing stable, low-cost processes suitable for large-scale production.Our R&D team has extensive experience in process optimization and the development of novel, safe, and environmentally friendly synthetic routes.We offer a comprehensive range of services to advance the R&D process of drug candidates, achieve key preclinical milestones at an early stage, and accelerate the overall drug discovery and development process.
Services
- Screening of commercial manufacturing routes
- Development and optimization of commercial processes via Design of Experiments (DoE) and Quality by Design (QbD)
- Unit operation studies and identification of critical process parameters (CPPs) for each step
- Studies on impurity structure, source, and control
- Definition of GMP starting materials
Route Design / Redesign
- Route design for target compounds of any structural complexity
- Application of state-of-the-art synthetic methodologies
- Design of catalytic and asymmetric synthesis strategies
- Statistical design of experiments
Optimization of Existing Synthetic Routes
- Development and optimization of commercial processes via Design of Experiments (DoE) and Quality by Design (QbD)
- Unit operation studies and identification of critical process parameters for each step
- Studies on impurity structure, origin, and control
- Definition of GMP starting materials
- Reaction screening to identify optimal reaction conditions
- Intermediate stability testing
Purification, Separation & Physical Form
- Improvement of compound purification and isolation protocols and establishment of robust separation methods
- Physical form monitoring
- Screening of classical resolution methods
- Impurity isolation and identification
Safety & Scale-Up
- Process safety assessment
- Compilation and analysis of experimental data to ensure safe scale-up production
- Application of comprehensive technologies to ensure data reliability
- RC-1, ARRST, DSC, and power-compensation calorimetry studies
- Provision of complete technical documentation packages
- Technology transfer support to enable large-scale production
- Seamless collaboration with other departments of Pharmaron