cell culture inoculation process

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

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

SubClass Of: inoculation process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › material addition process › inoculation process › cell culture inoculation process

Definition

inoculation process in which a cell-containing inoculum is introduced to initiate a cell culture process

Explanatory Notes

A cell culture inoculation process typically involves introducing cell-containing inoculum from a cryovial, seed culture, or intermediate vessel into fresh culture medium or vessel contents under controlled conditions. It marks the start of a new cell culture process within recovery, expansion, seed train, N-1, or production culture. It should be distinguished from culture medium charging, which occurs before inoculation, and from culture feed addition, which occurs after the cell culture process has begun.

Examples

• introducing resuspended cells into a shake flask containing fresh medium to initiate a recovery culture; adding thawed ultra-high-density CHO cell material from a working cell bank into a wave-mixed perfusion bioreactor to start culture growth; using seed culture to inoculate an N-1 perfusion bioreactor; inoculating fed-batch production bioreactors with cells from an N-1 perfusion bioreactor

Adapted From

• https://database.ich.org/sites/default/files/Q7%20Guideline.pdf and https://database.ich.org/sites/default/files/ICH_Q5A%28R2%29_Guideline_2023_1101.pdf

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

Formal Axioms

First-Order Logic Axioms

CellCultureInoculationProcess(x) → InoculationProcess(x) ∧ ∃m ∃c ∃ir ∃tr (MaterialEntity(m) ∧ CellPopulation(c) ∧ hasInput(x, m) ∧ hasContinuantPartAtAllTimes(m, c) ∧ InoculumRole(ir) ∧ hasRole(m, ir) ∧ TransferredMaterialRole(tr) ∧ hasRole(m, tr)) ∧ ∃p ∃cc (PlannedProcess(p) ∧ occurrentPartOf(x, p) ∧ CellCulture(cc) ∧ hasParticipantAtSomeTime(p, cc))

Semi-Formal Natural Language Axioms

if x is a ‘cell culture inoculation process’ then x is an ‘inoculation process’ that ‘has input’ some ‘material entity’ that ‘has continuant part at all times’ some ‘cell population’ and ‘has role’ some ‘inoculum role’ and some ‘transferred material role’, and x is ‘occurrent part of’ some ‘planned process’ that ‘has participant at some time’ some ‘cell culture’

Description Logic

constr:CellCultureInoculationProcess ⊑ constr:InoculationProcess

constr:CellCultureInoculationProcess ⊑ ∃ bfo:occurrent_part_of .(constr:PlannedProcess ⊓ ∃ bfo:has_participant_at_some_time .constr:CellCulture)

constr:CellCultureInoculationProcess ⊑ ∃ constr:hasInput .(bfo:material_entity ⊓ ∃ bfo:has_continuant_part_at_all_times .constr:CellPopulation ⊓ ∃ constr:hasRole .constr:InoculumRole ⊓ ∃ constr:hasRole .constr:TransferredMaterialRole)

SubClassOf: constr:InoculationProcess

SubClassOf: bfo:occurrent_part_of some (constr:PlannedProcess and bfo:has_participant_at_some_time some constr:CellCulture)

SubClassOf: constr:hasInput some (bfo:material_entity and bfo:has_continuant_part_at_all_times some constr:CellPopulation and constr:hasRole some constr:InoculumRole and constr:hasRole some constr:TransferredMaterialRole)