master cell bank
IRI: https://spec.industrialontologies.org/ontology/construct/MasterCellBank
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 › master cell bank
Definition
cell bank produced in a single preparation event from a well-characterized cell line or clone, stored under validated cryogenic conditions, and established as the authoritative reference lot for direct use or the generation of further banks
Explanatory Notes
The master cell bank is the definitive, long-term preserved reference lot of a cell line. It serves as the primary source for the generation of working cell banks, but it may also be used directly as a production or study starting material when required. Preparation and characterization of the master cell bank must comply with ICH Q5D requirements, including full documentation of cell origin and banking procedures, and rigorous testing to confirm identity, purity (absence of microbial, viral, or other adventitious agents), and stability. Depending on the cell type and intended use, additional evaluations such as tumorigenicity or karyology are also required.
Examples
- a master cell bank of CHO cells used to generate working cell banks for monoclonal antibody production; a master cell bank of HEK293 cells used for viral vector manufacturing; a master cell bank of a recombinant production cell line derived from a single selected clone
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
MasterCellBank(x) → CellBank(x)
Semi-Formal Natural Language Axioms
if x is a ‘master cell bank’ then x is a ‘cell bank’
Description Logic
SubClassOf: constr:CellBank