Services CMC Process Safety Assessment
Process Safety Assessment for Safe and Scalable Manufacturing
BioDuro evaluates thermal and reaction hazards early in process development to support safe scale-up from laboratory to pilot and manufacturing operations. Our process safety assessments help identify potential risks, define safe operating conditions, and support robust process development for APIs, intermediates, and regulatory starting materials.
Identifying Process Risks Before Scale-Up
Safe process development requires a thorough understanding of reaction energetics, thermal stability, and potential hazards. BioDuro performs process safety assessments to characterize reaction risks and establish safe operating parameters before scale-up and manufacturing.
Our team generates critical safety data to support process optimization, process characterization, and technology transfer activities, helping clients reduce development risk and improve manufacturing robustness.
Capabilities
- Thermal hazard evaluation
- Reaction calorimetry and heat flow analysis
- Process risk assessment for scale-up
- Characterization of critical process parameters (CPPs)
- Impurity purge and fate studies
- Safety assessment for process development and manufacturing
- Support for hazardous chemistry programs
- Process characterization for IND-enabling and commercial development
Instrumentation
Differential Scanning Calorimeter (DSC 3)
Used to evaluate thermal stability and characterize exothermic behavior of compounds, intermediates, and reaction mixtures.
OptiMax™ Calorimetric Workstation
Collects thermodynamic information under both isothermal and non-isothermal conditions to support reaction understanding, process optimization, and safe scale-up.
Why Clients Choose BioDuro
- Integrated with process development and manufacturing teams
- Early identification of scale-up risks
- Expertise in hazardous and complex chemistries
- Support for IND-enabling and commercial manufacturing programs
- Data-driven process characterization and safety evaluation
