upstream biomanufacturing process

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

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

SubClass Of: manufacturing process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › upstream biomanufacturing process

Definition

manufacturing process that includes preparation, expansion, cultivation, or propagation of biological material under controlled conditions to produce a process intermediate material or material product

Explanatory Notes

1) Upstream biomanufacturing process produces biological or biologically derived material for subsequent downstream processing or final use. 2) In some industrial practices, upstream processing includes the harvest step that removes material from the production culture; in others, harvest is treated as the starting point of downstream processing. This variability reflects organizational conventions rather than technical differences. 3) Upstream biomanufacturing processes may include activities such as cell thaw and recovery, seed expansion, inoculum preparation, production culture, fermentation, cell infection, transfection, viral propagation, or harvest, depending on the product modality and process convention.

Examples

• upstream process for monoclonal antibody production in CHO cells involving cell thaw, recovery, seed expansion, and production culture; upstream process for recombinant enzyme production in E. coli including inoculum preparation, fermentation, and harvest; upstream process of lentiviral vector manufacturing in HEK293 cells covering producer cell expansion, infection, and culture;

Adapted From

• https://www.cytivalifesciences.com/en/us/solutions/emerging-biotech/knowledge-center/biopharma-process-development-introduction and https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-process-validation-manufacture-biotechnology-derived-active-substances-and-data-be-provided-regulatory-submission_en.pdf and https://www.biophorum.com/download/cvp-case-study-interactive-version/

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

This term is expected to remain primitive because the exact boundary between upstream and downstream processing can vary by product modality, manufacturing method, and company-specific convention

Formal Axioms

First-Order Logic Axioms

UpstreamBiomanufacturingProcess(x) → ManufacturingProcess(x) ∧ ∃p (BiomanufacturingProductionProcess(p) ∧ hasOccurrentPart(x, p)) ∧ ∃o ((MaterialProduct(o) ∨ ProcessIntermediateMaterial(o)) ∧ hasSpecifiedOutput(x, o))

Semi-Formal Natural Language Axioms

if x is an ‘upstream biomanufacturing process’ then x is a ‘manufacturing process’ that ‘has occurrent part’ some ‘biomanufacturing production process’ and ‘has specified output’ some ‘material product’ or some ‘process intermediate material’

Description Logic

constr:UpstreamBiomanufacturingProcess ⊑ constr:ManufacturingProcess

constr:UpstreamBiomanufacturingProcess ⊑ ∃ bfo:has_occurrent_part .constr:BiomanufacturingProductionProcess

constr:UpstreamBiomanufacturingProcess ⊑ ∃ constr:hasSpecifiedOutput .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial)

SubClassOf: constr:ManufacturingProcess

SubClassOf: bfo:has_occurrent_part some constr:BiomanufacturingProductionProcess

SubClassOf: constr:hasSpecifiedOutput some (constr:MaterialProduct or constr:ProcessIntermediateMaterial)