production culture process
IRI: https://spec.industrialontologies.org/ontology/construct/ProductionCultureProcess
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 › production culture process
Definition
biomanufacturing production process during which a cell culture synthesizes, secretes, or accumulates the target product in a controlled environment provided by a bioreactor following expansion in a seed train
Semi-Formal Definition:
every instance of ‘production culture process’ is defined as exactly an instance of ‘biomanufacturing production process’ that ‘has participant at some time’ some ‘cell culture’, is ‘preceded by’ some ‘seed train’, ‘has participant at some time’ some ‘bioreactor’
Examples
- A production culture process grows HEK293 cells in suspension to generate viral vectors for gene therapy;A production culture process uses CHO cells in a fed-batch bioreactor to produce monoclonal antibodies;
Counter-Examples
- shake flask studies; seed train bioreactor runs;Cell-free protein synthesis;
Adapted From
- https://www.fda.gov/media/170955/download and https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients
Formal Axioms
First-Order Logic Definition
ProductionCultureProcess(x) ↔ BiomanufacturingProductionProcess(x) ∧ ∃y (CellCulture(y) ∧ hasParticipantAtSomeTime(x, y)) ∧ ∃s (SeedTrain(s) ∧ precededBy(x, s)) ∧ ∃b (Bioreactor(b) ∧ hasParticipantAtSomeTime(x, b))
Description Logic
constr:ProductionCultureProcess ≡ constr:BiomanufacturingProductionProcess ⊓ ∃ bfo:has_participant_at_some_time .constr:Bioreactor ⊓ ∃ bfo:has_participant_at_some_time .constr:CellCulture ⊓ ∃ bfo:preceded_by .constr:SeedTrain
constr:ProductionCultureProcess ⊑ constr:BiomanufacturingProductionProcess
EquivalentTo: constr:BiomanufacturingProductionProcess and bfo:has_participant_at_some_time some constr:Bioreactor and bfo:has_participant_at_some_time some constr:CellCulture and bfo:preceded_by some constr:SeedTrain
SubClassOf: constr:BiomanufacturingProductionProcess