cell therapy production process
IRI: https://spec.industrialontologies.org/ontology/construct/CellTherapyProductionProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
SubClass Of: biomanufacturing production process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › biomanufacturing production process › cell therapy production process
Definition
biomanufacturing production process that results in a cell population which constitutes the targeted product material
Examples
- manufacturing of autologous CAR-T cell therapy through patient-derived T-cell activation and expansion in culture bags; large-scale allogeneic NK-cell expansion in single-use bioreactors for immunotherapy
Adapted From
- https://www.cellandgene.com/topic/cell-therapy-manufacturing and https://www.fda.gov/media/156896/download
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. In particular constructs for representing cells as the target product are still missing.
Formal Axioms
First-Order Logic Axioms
CellTherapyProductionProcess(x) → BiomanufacturingProductionProcess(x) ∧ ∃o ((MaterialProduct(o) ∨ ProcessIntermediateMaterial(o)) ∧ hasSpecifiedOutput(x, o) ∧ ∃p (CulturedCellPopulation(p) ∧ hasContinuantPartAtAllTimes(o, p)))
Semi-Formal Natural Language Axioms
if x is a ‘cell therapy production process’ then x is a ‘biomanufacturing production process’ that ‘has specified output’ some ‘material product’ or some ‘process intermediate material’ that ‘has continuant part at all times’ some ‘cultured cell population’
Description Logic
constr:CellTherapyProductionProcess ⊑ constr:BiomanufacturingProductionProcess
constr:CellTherapyProductionProcess ⊑ ∃ constr:hasSpecifiedOutput .((constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial) ⊓ ∃ bfo:has_continuant_part_at_all_times .constr:CulturedCellPopulation)
SubClassOf: constr:BiomanufacturingProductionProcess
SubClassOf: constr:hasSpecifiedOutput some ((constr:MaterialProduct or constr:ProcessIntermediateMaterial) and bfo:has_continuant_part_at_all_times some constr:CulturedCellPopulation)