cell culture derived impurity role
IRI: https://spec.industrialontologies.org/ontology/construct/CellCultureDerivedImpurityRole
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 culture derived impurity role
Definition
manufacturing process related impurity role held by a material entity that originates from an acellular material component of a cell culture
Explanatory Notes
Cell culture-derived impurity role applies to impurities that originate from acellular materials present in or used to maintain a cell culture, such as media components, media supplements, inducers, antibiotics, surfactants, antifoam agents, selection agents, or other culture additives. These materials may remain in downstream or later manufacturing intermediates after harvest or purification. This role excludes materials originating from the production cells or host cell line itself, such as host cell proteins, host cell DNA, cell debris, or other host-cell-derived material. The term cell culture-derived therefore refers to the culture environment and non-cellular materials present in that environment, not to cells, cell parts, or host-cell molecules.
Examples
- the cell culture-derived impurity role of residual insulin from a cell culture medium supplement remaining in a harvested process intermediate; the cell culture-derived impurity role of residual antibiotic from a selection medium remaining in a downstream intermediate; the cell culture-derived impurity role of residual antifoam agent carried from a bioreactor culture into a harvest pool; the cell culture-derived impurity role of residual surfactant from a culture medium additive detected in a process intermediate; the cell culture-derived impurity role of residual inducer used during recombinant protein expression and carried into a clarified harvest; the cell culture-derived impurity role of residual nutrient feed component remaining in a harvested cell culture fluid;
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
CellCultureDerivedImpurityRole(x) → ManufacturingProcessRelatedImpurityRole(x)
Semi-Formal Natural Language Axioms
if x is a ‘cell culture derived impurity role’ then x is a ‘manufacturing process related impurity role’