manufacturing process related impurity role

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

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

SubClass Of: material impurity role

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:role › material impurity role › manufacturing process related impurity role

Direct subclasses:

• cell culture derived impurity role
• cell substrate derived impurity role
• downstream derived impurity role

Definition

material impurity role held by a material entity that is present in a process intermediate material or material product and whose presence is attributable to planned or inherent aspects of manufacturing execution

Explanatory Notes

manufacturing process related impurity role covers impurities whose presence is attributable to the manufacturing process rather than to adventitious contamination. Planned aspects include materials, equipment, consumables, or process aids that are intentionally used in the process, such as reagents, solvents, chromatography resins, filters, tubing, bags, cleaning agents, or product-contact surfaces. Inherent aspects include materials generated or released as a normal consequence of executing the process, such as process-derived byproducts, residual intermediates, host cell proteins, residual DNA, wear particles, lubricants, extractables, or leachables. This role should be distinguished from contaminant role, which applies to material adventitiously introduced during manufacturing.

Examples

• the manufacturing process related impurity role of residual Protein A ligand leached from chromatography resin into a drug substance intermediate; the manufacturing process related impurity role of host cell protein remaining in a purified monoclonal antibody intermediate; the manufacturing process related impurity role of residual host cell DNA in a drug substance intermediate; the manufacturing process related impurity role of residual solvent remaining after a synthesis or purification step;

Adapted From

• https://www.fda.gov/media/182387/download and https://database.ich.org/sites/default/files/Q6B%20Guideline.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 necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

ManufacturingProcessRelatedImpurityRole(x) → MaterialImpurityRole(x) ∧ ∃m (MaterialEntity(m) ∧ roleOf(x, m) ∧ ∃w ((MaterialProduct(w) ∨ ProcessIntermediateMaterial(w)) ∧ properContinuantPartOfAtSomeTime(m, w)))

Semi-Formal Natural Language Axioms

if x is a ‘manufacturing process related impurity role’ then x is a ‘material impurity role’ that is the ‘role of’ some ‘material entity’ that is a ‘proper continuant part of at some time’ some ‘material product’ or some ‘process intermediate material’

Description Logic

constr:ManufacturingProcessRelatedImpurityRole ⊑ constr:MaterialImpurityRole

constr:ManufacturingProcessRelatedImpurityRole ⊑ ∃ constr:roleOf .(bfo:material_entity ⊓ ∃ bfo:proper_continuant_part_of_at_some_time .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial))

SubClassOf: constr:MaterialImpurityRole

SubClassOf: constr:roleOf some (bfo:material_entity and bfo:proper_continuant_part_of_at_some_time some (constr:MaterialProduct or constr:ProcessIntermediateMaterial))