cell substrate derived impurity role
IRI: https://spec.industrialontologies.org/ontology/construct/CellSubstrateDerivedImpurityRole
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 › cell substrate derived impurity role
Definition
manufacturing process related impurity role held by a material entity that originates from cells used in a manufacturing process
Explanatory Notes
Cell-derived impurity role applies to impurities originating from cells used in manufacturing. Examples include host cell proteins, host cell DNA, host cell RNA, cell debris, host-cell-derived lipids, or other material released from or derived from production cells. This role should be distinguished from cell culture-derived impurity role, which applies to impurities originating from non-cellular materials present in or added to the culture environment, such as media components, nutrient feeds, supplements, inducers, antibiotics, surfactants, or antifoam agents.
Examples
- the cell substrate-derived impurity role of host cell protein remaining in a monoclonal antibody process intermediate; the cell substrate-derived impurity role of residual host cell DNA detected in a drug substance intermediate; the cell substrate-derived impurity role of host cell RNA remaining after harvest clarification;
Adapted From
- https://database.ich.org/sites/default/files/Q6B%20Guideline.pdf and https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnological-biological-entities_en.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
CellSubstrateDerivedImpurityRole(x) → ManufacturingProcessRelatedImpurityRole(x)
Semi-Formal Natural Language Axioms
if x is a ‘cell substrate derived impurity role’ then x is a ‘manufacturing process related impurity role’