viral clearance
IRI: https://spec.industrialontologies.org/ontology/construct/ViralClearance
Defined In: https://spec.industrialontologies.org/ontology/biopharma/ManufacturingExecution/
SubClass Of: manufacturing process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › viral clearance
Direct subclasses:
Definition
manufacturing process that results in the elimination of a target virus by either removing viral particles or by inactivating its infectivity
Explanatory Notes
1) Virus Removal: Physical separation of virus particles from the intended product. 2) Inactivation: Reduction of virus infectivity caused by chemical or physical modification 3) Viral clearance is typically demonstrated through studies in which known quantities of viruses are deliberately added to the manufacturing process, and the ability of specific steps—such as filtration, chromatography, or chemical treatment—to reduce or eliminate viral infectivity is measured. These studies use relevant and model viruses to represent a broad range of possible contaminants and quantify effectiveness as a log reduction in viral load.
Examples
- anion exchange chromatography operated in flow-through mode to remove retrovirus-like particles from CHO cell harvest; Viral inactivation was performed by incubating monoclonal antibody solutions in 50 mM citrate buffer at pH 3.0 for 40 minutes at low ionic strength, followed by neutralization to pH 5.0 under higher ionic strength conditions;
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-r1-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-animal-origin_en.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
Insufficient constructs are present to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
ViralClearance(x) → ManufacturingProcess(x) ∧ ∃r (RecipeProcessStage(r) ∧ prescribes(r, x))
Semi-Formal Natural Language Axioms
if x is a ‘viral clearance’ then x is a ‘manufacturing process’ and is ‘prescribed by’ some ‘recipe process stage’