clone stability study

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

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

SubClass Of: planned process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › clone stability study

Definition

planned process composed of one or more measurement or monitoring processes, designed to evaluate whether a selected cell clone maintains its key phenotypic characteristics, genotypic traits, and genetic integrity over time and across multiple generations of cell division

Explanatory Notes

The results of such a study are often process dependent. Best practice would be to consider the results applicable only for the process that is used to obtain the data.

Examples

• Assessing the stability of a CHO cell clone by monitoring titer and cell growth during a 14-day fed-batch culture in a 5 L bioreactor; : Evaluating the genetic, phenotypic, and productivity stability of CHO-K1 clone 3B7 producing anti-TNFα antibody over 70 days of continuous culture (equivalent to ~140 generations).

Synonyms

• clone stability study process

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

CloneStabilityStudy(x) → PlannedProcess(x) ∧ ∃y (ClonedCellLine(y) ∧ hasInput(x, y)) ∧ ∃z ((MeasurementProcess(z) ∨ MonitoringProcess(z)) ∧ hasOccurrentPart(x, z))

Semi-Formal Natural Language Axioms

if x is a ‘clone stability study’ then x is a ‘planned process’ that ‘has input’ some ‘cloned cell line’ and ‘has occurrent part’ some ‘measurement process’ or ‘monitoring process’

Description Logic

constr:CloneStabilityStudy ⊑ constr:PlannedProcess

constr:CloneStabilityStudy ⊑ ∃ bfo:has_occurrent_part .(constr:MeasurementProcess ⊔ constr:MonitoringProcess)

constr:CloneStabilityStudy ⊑ ∃ constr:hasInput .constr:ClonedCellLine

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:has_occurrent_part some (constr:MeasurementProcess or constr:MonitoringProcess)

SubClassOf: constr:hasInput some constr:ClonedCellLine