endotoxin role
IRI: https://spec.industrialontologies.org/ontology/construct/EndotoxinRole
Defined In: https://spec.industrialontologies.org/ontology/biopharma/MolecularEntity/
SubClass Of: molecular toxin role
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:role › molecular entity role › molecular toxin role › endotoxin role
Definition
molecular toxin role held by a lipopolysaccharide (LPS) that originates from Gram-negative bacterial cellular material
Explanatory Notes
1) This role excludes protein exotoxins, viral agents, inorganic poisons, non-microbial pyrogens, ions, and non-viable particulate matter that is not lipopolysaccharide-derived. 2) In biologics manufacturing, the endotoxin role identifies lipopolysaccharide impurities originating from Gram-negative bacteria that must be quantified and limited in material samples, single-use parts, buffers, purification pools, in-process holds, or final product samples based on pyrogen-safety acceptance thresholds. Endotoxin control is assessed through corresponding sample-level measurable attributes, such as endotoxin load or endotoxin content, and supports contamination risk mitigation, process comparability, in-process hold and filtration decisions, and product release decisions.
Examples
- Lipopolysaccharide from Gram-negative bacterial contamination bearing an endotoxin role in a buffer sample; Lipopolysaccharide impurity bearing an endotoxin role in a purification pool; Lipopolysaccharide residue bearing an endotoxin role on a single-use component extractable or rinse sample; Lipopolysaccharide impurity bearing an endotoxin role in a final drug substance sample.
Adapted From
- https://www.thermofisher.com/rs/en/home/life-science/protein-biology/protein-purification-isolation/protein-purification/endotoxin-quantitation-removal.html” and https://www.biophorum.com/download/cvp-case-study-interactive-version/ and https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers”
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 a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
EndotoxinRole(x) → MolecularToxinRole(x) ∧ ∃y (roleOf(x, y) ∧ Lipopolysaccharide(y))
Semi-Formal Natural Language Axioms
if x is an ‘endotoxin role’ then x is a ‘molecular toxin role’ and x is a ‘role of’ some ‘lipopolysaccharide’
Description Logic
constr:EndotoxinRole ⊑ constr:MolecularToxinRole
constr:EndotoxinRole ⊑ ∃ constr:roleOf .constr:Lipopolysaccharide
SubClassOf: constr:MolecularToxinRole
SubClassOf: constr:roleOf some constr:Lipopolysaccharide