prior knowledge information content entity
IRI: https://spec.industrialontologies.org/ontology/construct/PriorKnowledgeInformationContentEntity
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingProcessLifecycle/
SubClass Of: information content entity
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › prior knowledge information content entity
Definition
information content entity that represents scientifically grounded understanding of a product, material, or process derived from prior experience, technical literature, historical data, and/or established scientific and engineering principles
Explanatory Notes
1) Prior knowledge can be derived from publicly available or internally documented sources. 2) A prior knowledge information content entity may represent only the portion relevant to a stated scope, such as a unit operation, parameter, quality attribute, scale range, or control decision. 3) Data derived from relevant prior knowledge, including platform manufacturing, can be leveraged. Accordingly, prior knowledge may be operationalized in data-derived forms such as statistical summaries and governed models, including Bayesian prior distributions, provided scope and provenance are specified.
Examples
- a prior knowledge summary stating that low-pH viral inactivation at a specified pH and hold time range has previously achieved acceptable viral clearance for a platform monoclonal antibody process; a prior knowledge report describing how Protein A resin binding capacity has varied across prior products, resin lots, and operating conditions; a Bayesian prior distribution for a glycosylation model parameter derived from historical fed-batch runs and used to support adaptive process control;
Adapted From
- https://database.ich.org/sites/default/files/Q11%20Guideline.pdf and https://database.ich.org/sites/default/files/Q10%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 define necessary and sufficient conditions for this class. In particular, further work is needed to clarify how prior knowledge information content entities relate to evidence records, data summaries, models, reports, specifications, and other kinds of information content entities.
Formal Axioms
First-Order Logic Axioms
PriorKnowledgeInformationContentEntity(x) → InformationContentEntity(x)
Semi-Formal Natural Language Axioms
if x is a ‘prior knowledge information content entity’ then x is an ‘information content entity’