process model development
IRI: https://spec.industrialontologies.org/ontology/construct/ProcessModelDevelopment
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 › process model development
Definition
planned process in which a mathematical or empirical model is developed to represent or predict a manufacturing process or relationships among its process parameters, material attributes, quality attributes, or performance indicators
Explanatory Notes
1) This process uses experimental, historical, or platform data to generate and validate quantitative models that explain and predict the effects of process parameters and material attributes on critical quality attributes (CQAs) and key performance indicators (KPIs). 2) It supports the definition of design space, setpoints, control ranges, and parameter criticality during process characterization and provides a scientific basis for subsequent validation and lifecycle verification activities. 3) Process model development commonly occurs as part of manufacturing process characterization, but it can also occur during process control development, continued process verification, process improvement, or other lifecycle activities. 4) Detailed representation of a computation model is being developed within the IOF reference ontologies and will be incorporated in the future.
Examples
- During cell-culture process characterization, a mechanistic oxygen-transfer model and a data-driven regression model are developed to predict viable-cell density (performance indicator) and glycosylation profile (critical quality attribute) as functions of agitation rate, dissolved-oxygen setpoint, and glucose feed rate.
Adapted From
- https://www.biopharminternational.com/view/process-characterization-essentials-process-understanding-and-health-authorities-guidance and https://www.cytivalifesciences.com/en/us/insights/downstream-process-characterization
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs present to represent necessary and sufficient conditions. In particular treatment of models is lacking.
Formal Axioms
First-Order Logic Axioms
ProcessModelDevelopment(x) → PlannedProcess(x)
Semi-Formal Natural Language Axioms
if x is a ‘process model development’ then x is a ‘planned process’