viral inactivation
IRI: https://spec.industrialontologies.org/ontology/construct/ViralInactivation
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
SubClass Of: viral clearance
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › viral clearance › viral inactivation
Definition
viral clearance during which viral infectivity is reduced by physically or chemically modifying the input material
Explanatory Notes
1) In viral inactivation the viral particles are not necessarily removed from the input 2) Common inactivation methods include heat (e.g., pasteurization), acidic pH, solvent-detergent treatment, or UV exposure. Effectiveness is validated through spiking studies: known amounts of virus are added to the process and their infectivity is monitored over time.
Examples
- 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; Viral inactivation was performed by treating the product stream with 0.3% Triton X-100 for 60 minutes at room temperature to disrupt lipid-enveloped viruses.
Adapted From
- Merck Biopharmaceutical Application Guide and 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
ViralInactivation(x) → ViralClearance(x)
Semi-Formal Natural Language Axioms
if x is a ‘viral inactivation’ then x is a ‘viral clearance’