critical quality attribute
IRI: https://spec.industrialontologies.org/ontology/construct/CriticalQualityAttribute
Defined In: https://spec.industrialontologies.org/ontology/biopharma/Parameter/
SubClass Of: quality attribute
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › quality attribute › critical quality attribute
Definition
quality or capability prescribed by a critical quality attribute specification
Semi-Formal Definition:
every instance of ‘critical quality attribute’ is defined as exactly an instance of ‘quality’ or ‘capability’ that is ‘prescribed by’ some ‘critical quality attribute specification’
Explanatory Notes
See the expanded definition under the corresponding specification class. The term is formalized here as a defined class by referring to its corresponding specification class and exists primarily for ontological modeling and implementation convenience.
Examples
- host-cell protein impurity level in the clarified lysate; aggregate content in the purified monoclonal antibody; endotoxin level in the filled drug product; glycan composition of the monoclonal antibody drug substance
Formal Axioms
First-Order Logic Definition
CriticalQualityAttribute(x) ↔ (Quality(x) ∨ Capability(x)) ∧ ∃s(CriticalQualityAttributeSpecification(s) ∧ prescribedBy(x, s))
Description Logic
constr:CriticalQualityAttribute ≡ (bfo:quality ⊔ constr:Capability) ⊓ ∃ constr:prescribedBy .constr:CriticalQualityAttributeSpecification
EquivalentTo: (bfo:quality or constr:Capability) and constr:prescribedBy some constr:CriticalQualityAttributeSpecification
SubClassOf: constr:QualityAttribute