cell line development
IRI: https://spec.industrialontologies.org/ontology/construct/CellLineDevelopment
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 › cell line development
Definition
planned 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) A cell line development process ends with the banking of the resulting 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-intensive. 4) Engineering in this context includes experimental modification of an existing cell population or cell line to establish a new cell line with desired characteristics, such as introduction of genetic material, immortalization, or another 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) → PlannedProcess(x) ∧ ∃g∃c∃l∃b(GeneticTransformationProcess(g) ∧ CloneSelectionProcess(c) ∧ ClonedCellLine(l) ∧ CellBanking(b) ∧ hasOccurrentPart(x,g) ∧ hasOccurrentPart(x,c) ∧ precedes(g,c) ∧ temporallyStartedBy(x,g) ∧ hasSpecifiedOutput(c,l) ∧ hasSpecifiedOutput(x,l) ∧ hasParticipantAtSomeTime(b,l) ∧ (meets(x,b) ∨ temporallyOverlaps(x,b)))
Semi-Formal Natural Language Axioms
if x is a ‘cell line development’ then x is a ‘planned process’ that is ‘temporally started by’ some ‘genetic transformation process’ g and ‘has occurrent part’ g and some ‘clone selection process’ c, where g ‘precedes’ c, and c ‘has specified output’ some ‘cloned cell line’ l that is also the ‘specified output’ of x, and x either ‘meets’ or ‘temporally overlaps’ some ‘cell banking’ that ‘has participant at some time’ that same l
Description Logic
constr:CellLineDevelopment ⊑ constr:PlannedProcess
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:PlannedProcess
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