working cell bank
IRI: https://spec.industrialontologies.org/ontology/construct/WorkingCellBank
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: cell bank
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:independent continuant › bfo:material entity › bfo:object aggregate › cell bank › working cell bank
Definition
cell bank prepared from cells recovered from one or more containers of a master cell bank and stored under validated cryogenic conditions as a source of cryopreserved cells for routine use in research, development, or manufacturing
Explanatory Notes
The source cells are expanded into a homogeneous suspension from one or more vials of the master cell bank, dispensed into multiple uniform containers, and cryopreserved under validated long-term storage conditions. The resulting working cell bank serves as the routine production cell source, allowing repeated use while minimizing the need to access the master cell bank directly.
Examples
- working cell bank of CHO cells used to inoculate production seed trains; a working cell bank generated from a master cell bank for monoclonal antibody manufacturing; a working cell bank of HEK293 cells used for viral vector production;
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-d-derivation-and-characterisation-cell-substrates-used-production-biotechnologicalbiological-products-step-5_en.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
WorkingCellBank(x) → CellBank(x)
Semi-Formal Natural Language Axioms
if x is a ‘working cell bank’ then x is a ‘cell bank’
Description Logic
SubClassOf: constr:CellBank