downstream derived impurity role
IRI: https://spec.industrialontologies.org/ontology/construct/DownstreamDerivedImpurityRole
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: manufacturing process related impurity role
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:role › material impurity role › manufacturing process related impurity role › downstream derived impurity role
Definition
manufacturing process related impurity role held by a material entity that originates from a raw material, production consumable, or equipment used in a downstream manufacturing process
Examples
- the downstream-derived impurity role of residual Protein A ligand leached from chromatography resin into a drug substance intermediate; the downstream-derived impurity role of chromatography resin leachable material detected in an elution pool; the downstream-derived impurity role of filter-derived particulate matter introduced during sterile filtration; the downstream-derived impurity role of a filter-derived organic leachable detected in a formulation intermediate; the downstream-derived impurity role of residual low-pH viral inactivation reagent carried into a neutralized process intermediate;
Adapted From
- https://database.ich.org/sites/default/files/Q6B%20Guideline.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to create necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
DownstreamDerivedImpurityRole(x) → ManufacturingProcessRelatedImpurityRole(x)
Semi-Formal Natural Language Axioms
if x is a ‘downstream derived impurity role’ then x is a ‘manufacturing process related impurity role’