viral filtration

IRI: https://spec.industrialontologies.org/ontology/construct/ViralFiltration

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/

SubClass Of: viral removal process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › viral clearance › viral removal process › viral filtration

Definition

viral removal process in which viral particles are physically separated from the input material through a nanofiltration process

Explanatory Notes

1) This process relies on size-based exclusion to retain viruses on the filter surface while allowing the target product to pass through. It typically involves one or more filtration steps, which may be arranged in series or parallel, and can be combined with other virus removal processes such as chromatographic steps validated for virus clearance. Pre-filtration is often used to protect the virus filter and maintain performance. 2) The filtration uses membranes with nanometer-scale pore sizes and is predominantly performed via nanofiltration. While ultrafiltration may assist in removing larger viruses such as retroviruses, it is not accepted as a standalone method for regulatory purposes; therefore, a nanofiltration step is required. 3) The process is rigorously designed and validated under regulatory guidance to ensure robust virus removal (typically achieving ≥4 log₁₀ reduction) while maintaining product yield and scalability.

Examples

  • Viral filtration was carried out using a Planova BioEX filter after a 0.2 µm prefilter process, applied to a monoclonal antibody solution in defined buffer conditions.

Adapted From

  • https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-r2-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin-step-2b_en.pdf and https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/photometer-files/269/820/viral-clearance-study-wp8407en-ms.pdf?srsltid=AfmBOoqxcqPF9uWz0DC3JJc6T_VPSw48iogXw9vpj89IzaVMeeS-NE-b

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 

ViralFiltration(x) → ViralRemovalProcess(x) ∧ ∃n (NanofiltrationProcess(n) ∧ hasOccurrentPart(x, n))

Semi-Formal Natural Language Axioms

if x is a ‘viral filtration’ then x is a ‘viral removal process’ and ‘has occurrent part’ some ‘nanofiltration process’

Description Logic

constr:ViralFiltration ⊑ constr:ViralRemovalProcess

constr:ViralFiltration ⊑ ∃ bfo:has_occurrent_part .constr:NanofiltrationProcess

SubClassOf: constr:ViralRemovalProcess

SubClassOf: bfo:has_occurrent_part some constr:NanofiltrationProcess