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
Identification of critical quality attributes (CQAs)
Identification of critical process parameters (CPPs)
Scale-down model (SDM) qualification
Unit operation(s) DOE studies
Process control strategy
Supporting Process Characterization Studies
Intermediate hold-time studies
Resin reuse studies
Membrane reuse studies