Cytovance® offers process characterization (PC) services to support product commercialization for in-house developed or established processes. Process Characterization studies are necessary to identify critical process parameters (CPPs), material attributes, control strategy, and design space. PC will justify the operating ranges and process control strategy for the scale-up process.
Cytovance® uses a Quality by Design approach (risk- and knowledge-based) for process validation (PV) and continuous lifecycle management. Thorough process characterization provides a good foundation for QbD. Our PC Department is seamlessly integrated with the PV Department in Manufacturing. Cytovance® incorporates design of experiments (DOE) that apply statistics during decision-making for scale-down model(s) and determining relationships and interactions between inputs (e.g. process parameters) and outputs (e.g. critical quality attributes).
PROCESS CHARACTERIZATION KEY SERVICES
- Risk assessments
- Identification of critical quality attributes (CQAs)
- Identification of critical process parameters (CPPs)
- At-scale runs
- Scale-down model (SDM) qualification
- Unit operation(s) DOE studies
- Design space
- Process control strategy
SUPPORTING PROCESS CHARACTERIZATION STUDIES
- Buffer stability
- Intermediate hold-time studies
- Resin reuse studies
- Membrane reuse studies