manufacturing process characterization process
IRI: https://spec.industrialontologies.org/ontology/construct/ManufacturingProcessCharacterizationProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingProcessLifecycle/
SubClass Of: planned process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process characterization process
Definition
planned process that systematically develops and documents scientific understanding of how process parameters and material attributes influence quality and performance outcomes
Explanatory Notes
The process integrates analysis of historical data, designed experiments, and risk assessment to determine the criticality of parameters and material attributes, quantify their relationships with critical quality attributes (CQAs) and key performance indicators (KPIs), and establish scientifically justified parameter ranges that support control strategy, validation, and lifecycle management.
Examples
- cell culture process characterization to determine the effect of temperature and glucose feeding on product glycosylation
Counter-Examples
- unplanned troubleshooting of a failed batch
Adapted From
- https://www.6sigma.us/process-improvement/process-characterization/ and https://www.biopharminternational.com/view/rational-step-wise-approach-process-characterization
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
This class is expected to remain primitive.
Formal Axioms
First-Order Logic Axioms
ManufacturingProcessCharacterizationProcess(x) → PlannedProcess(x)
Semi-Formal Natural Language Axioms
if x is a ‘manufacturing process characterization process’ then x is a ‘planned process’