polishing process
IRI: https://spec.industrialontologies.org/ontology/construct/PolishingProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
SubClass Of: purification process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › purification process › polishing process
Definition
purification process in which minute amounts of impurities are removed and that occurs as one of the final processes of drug substance manufacturing process
Explanatory Notes
Polishing typically follows primary capture and intermediate purification. It removes residual impurities such as host cell proteins, DNA, viruses, and product variants, and is performed prior to formulation and fill–finish step
Examples
- anion exchange chromatography used to remove residual DNA and endotoxins from a monoclonal antibody solution; cation exchange chromatography applied to reduce host cell protein levels and achieve charge variant specification; nanofiltration performed as a polishing step to remove trace viral particles following prior inactivation;
Counter-Examples
- protein A affinity chromatography used as a primary capture step for monoclonal antibodies; depth filtration of harvested cell culture fluid to remove cells and debris; anion exchange chromatography used early in a multi-step purification to remove bulk impurities;
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
PolishingProcess(x) → PurificationProcess(x)
Semi-Formal Natural Language Axioms
if x is a ‘polishing process’ then x is a ‘purification process’