drug product design process

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

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

SubClass Of: planned process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › drug product design process

Definition

planned process performed to develop a product that can deliver the desired quality target product profile over its entire shelf life

Explanatory Notes

This process aims to ensure that the product meets patient needs and maintains performance through shelf life, supported by clinical and stability studies. Key elements commonly include: 1) Physical, chemical, and biological characterization of the drug substance 2) Identification and selection of excipient type and grade, including knowledge of intrinsic excipient variability 3) Characterization of drug–excipient interactions 4) Formulation optimization and identification of critical material attributes of both excipients and drug substance.

Examples

Drug product design process for a monoclonal antibody formulation that evaluates buffer composition, stabilizers, surfactant level, and container closure system to support potency, purity, stability, and visible particle control over shelf life; Drug product design process for a lyophilized biologic that selects excipients and cycle-relevant formulation attributes to support cake appearance, reconstitution time, residual moisture, potency, and stability;

Adapted From

https://pmc.ncbi.nlm.nih.gov/articles/PMC4070262/

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

DrugProductDesignProcess(x) → PlannedProcess(x) ∧ ∃p (precededBy(x, p) ∧ CriticalQualityAttributeIdentificationProcess(p))

Semi-Formal Natural Language Axioms

if x is a ‘drug product design process’ then x is a ‘planned process’ and x is ‘preceded by’ some ‘critical quality attribute identification process’

Description Logic

constr:DrugProductDesignProcess ⊑ constr:PlannedProcess

constr:DrugProductDesignProcess ⊑ ∃ bfo:preceded_by .constr:CriticalQualityAttributeIdentificationProcess

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:preceded_by some constr:CriticalQualityAttributeIdentificationProcess