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 .constr:Bioreactor ⊓ ∃ bfo:has_participant .constr:CellCulture ⊓ ∃ bfo:preceded_by .constr:SeedTrain

constr:ProductionCultureProcess ⊑ constr:BiomanufacturingProductionProcess

EquivalentTo: constr:BiomanufacturingProductionProcess and bfo:has_participant some constr:Bioreactor and bfo:has_participant some constr:CellCulture and bfo:preceded_by some constr:SeedTrain

SubClassOf: constr:BiomanufacturingProductionProcess