cell line development

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

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

SubClass Of: manufacturing process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › cell line development

Definition

manufacturing process in which a cell line is engineered to produce a therapeutic biomolecule or biologic

Explanatory Notes

1) Cell line development involves one or more clonal selection processes to isolate and expand a genetically stable monoclonal population with desirable traits. 2) Cell line development process ends with the banking of the particular cell line 3) Cell line development is one of the first steps in the process of developing a biopharmaceutical product. This step is time consuming and resource-intense. 4) Engineering in this context means that the cell line is created, either through passaging of a primary cell culture to relative genetic stability and compositional homogeneity, or through some experimental modification of an existing cell line to produce a new line with novel characteristics (e.g. immortalization or some other stable genetic modification). 5) Regulatory standards in biologics require proof of monoclonality for a production cell line. This implies that it originates from a single progenitor cell, regardless of whether one calls it a clone or a line. In practice, a clone is the starting point for development: once selected and scaled, it becomes a permanent cell line with specific attributes used for product manufacture.

Examples

  • Cell line development that starts with transfecting a CHO population with a vector containing the genetic sequence for the cNIST mAb and ends with banking the cell line stemming from a clone that had the highest mAb productivity

Synonyms

  • establishing cell line

Adapted From

  • https://www.sartorius.com/en/applications/biopharmaceutical-manufacturing/cell-line-development/what-is-cell-line-development and from OBI:establishing cell lines

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 

CellLineDevelopment(x) → ManufacturingProcess(x) ∧ ∃g ∃c (GeneticTransformationProcess(g) ∧ CloneSelectionProcess(c) ∧ hasOccurrentPart(x, g) ∧ hasOccurrentPart(x, c) ∧ precedes(g, c)) ∧ ∃o (CellLine(o) ∧ hasSpecifiedOutput(x, o)) ∧ temporallyStartedBy(x, g) ∧ (∃b (CellBanking(b) ∧ meets(x, b)) ∨ ∃b (CellBanking(b) ∧ temporallyOverlaps(x, b)))

Semi-Formal Natural Language Axioms

if x is a ‘cell line development’ then x is a ‘manufacturing process’ and ‘has occurrent part’ some ‘genetic transformation process’ that ‘precedes’ some ‘clone selection process’ and ‘has occurrent part’ some ‘clone selection process’ and ‘has specified output’ some ‘cell line’ and is ‘temporally started by’ some ‘genetic transformation process’ and either ‘meets’ some ‘cell banking’ or ‘temporally overlaps’ some ‘cell banking’

Description Logic

constr:CellLineDevelopment ⊑ constr:ManufacturingProcess

constr:CellLineDevelopment ⊑ ∃ constr:meets .constr:CellBanking ⊔ ∃ constr:temporallyOverlaps .constr:CellBanking

constr:CellLineDevelopment ⊑ ∃ bfo:has_occurrent_part .constr:CloneSelectionProcess

constr:CellLineDevelopment ⊑ ∃ bfo:has_occurrent_part .(constr:GeneticTransformationProcess ⊓ ∃ bfo:precedes .constr:CloneSelectionProcess)

constr:CellLineDevelopment ⊑ ∃ constr:hasSpecifiedOutput .constr:CellLine

constr:CellLineDevelopment ⊑ ∃ constr:temporallyStartedBy .constr:GeneticTransformationProcess

SubClassOf: constr:ManufacturingProcess

SubClassOf: constr:meets some constr:CellBanking or constr:temporallyOverlaps some constr:CellBanking

SubClassOf: bfo:has_occurrent_part some constr:CloneSelectionProcess

SubClassOf: bfo:has_occurrent_part some (constr:GeneticTransformationProcess and bfo:precedes some constr:CloneSelectionProcess)

SubClassOf: constr:hasSpecifiedOutput some constr:CellLine

SubClassOf: constr:temporallyStartedBy some constr:GeneticTransformationProcess