Changes in 🟢 Biopharma Parameter Ontology

Maturity: 🟢 Released

Added

Classes

Construct	Definition
`AgitationRate`	rate process profile at which imposed motion is applied to agitate a material
`BiologicalActivity`	capability of a drug substance, drug product, or relevant process intermediate material to achieve a defined biological effect
`BiomassSpecificProductivity`	manufacturing process productivity whose magnitude is normalized by biomass mass
`BiomoleculePrimaryStructure`	quality of a DNA, RNA, peptide, or protein molecule that is determined by the linear order of its nucleotide or amino acid residues
`CarbonDioxideEvolutionRate`	rate process profile at which carbon dioxide is produced by cells within a cell culture
`CellCultureDoublingTime`	temporal interval over which the size of a cell population doubles
`CellPopulationGrowthRate`	population growth rate of a cell population with respect to change in its number of cells
`CellSpecificProductivity`	manufacturing process productivity whose magnitude is normalized by cell amount, typically viable cell amount
`CriticalMaterialAttribute`	quality or capability that is prescribed by an input critical material attribute specification
`CultureSplitRatio`	ratio of a source cell culture to one or more resulting cell cultures established from that source culture during passaging
`DissolutionRate`	rate process profile at which a solute dissolves in a solvent
`DrugPotency`	quality of a drug substance, drug product, or relevant process intermediate material that is the quantitative degree of its biological activity
`FlowRate`	rate process profile at which material is transported across a specified surface or boundary
`InputCriticalMaterialAttributeSpecification`	input material attribute specification that prescribes some quality, capability, constitution, or composition whose variation can have a significant impact on the quality of the output material
`InputMaterialAttribute`	quality or capability that is prescribed by an input material attribute specification
`InputMaterialAttributeSpecification`	input specification that prescribes some quality, capability, constitution, or composition of an input material that can have an impact on process performance or on the quality of the output material
`ManufacturingProcessProductivity`	rate process profile at which process intermediate material or material product is produced in a manufacturing process under specified conditions
`MassFlowRate`	flow rate whose magnitude is determined by the mass of material transported across the specified surface or boundary per unit of elapsed time
`MetaboliteUptakeRate`	rate process profile at which a metabolite is taken up by cells within a cell culture
`NormalizedFlowRate`	flow rate whose magnitude is expressed relative to a specified reference quantity
`OxygenUptakeRate`	rate process profile at which oxygen is consumed by cells within a cell culture
`PlannedProcessYield`	process characteristic that is the ratio of a specified output quantity produced in a planned process to a specified reference quantity associated with that planned process
`PopulationGrowthRate`	rate process profile that captures change in the size of a population per unit of elapsed time
`ProductTiter`	concentration of a process intermediate material or material product that is determined by the amount of a target product in that process intermediate material or material product per unit volume
`ProteinSecondaryStructure`	physical structure of a protein that is the local three-dimensional arrangement of segments of its polypeptide backbone, commonly characterized by recurring backbone hydrogen-bonding patterns
`ProteinTertiaryStructure`	physical structure of a protein that is the overall three-dimensional arrangement arising from the conformation of its polypeptide chain, including the spatial organization of its secondary structure elements relative to one another
`RateProcessProfile`	process profile that captures variation in an attribute of a process or one of its participants per unit of elapsed time
`SpecificCellPopulationGrowthRate`	cell population growth rate whose magnitude is normalized by the size of that cell population
`TotalMaterialAdded`	process characteristic that is the total quantity of a particular material that is added during a particular process
`VesselVolumesPerDay`	normalized flow rate whose magnitude is the volume of medium exchanged per day relative to the working volume
`VolumetricFlowRate`	flow rate whose magnitude is determined by the volume of material transported across the specified surface or boundary per unit of elapsed time
`VolumetricProductivity`	manufacturing process productivity whose magnitude is normalized by a specified reference volume of process material
`WorkingVolume`	volume that is a quality of process material and that is the volume occupied by that process material in a vessel during a planned process
`YieldPerBiomass`	planned process yield that characterizes the quantity of a specified material output produced in a planned process relative to the quantity of biomass formed in that planned process
`YieldPerSubstrate`	planned process yield that characterizes the quantity of a specified material output produced in a planned process relative to the quantity of a specified substrate consumed in that planned process

Object Properties

Construct	Definition
`hasPerformanceIndicator`	relation between an agent, planned process, organization, or piece of equipment and a performance indicator indicating that measurements of the indicator are used to evaluate the effectiveness of that entity with respect to a particular objective
`hasProcessParameter`	relation between a planned process and a process parameter indicating that the parameter is monitored or controlled during the execution of that planned process
`isPerformanceIndicatorOf`	relation between a performance indicator and an agent, planned process, organization, or piece of equipment indicating that measurements of the indicator are used to evaluate the effectiveness of that entity with respect to a particular objective
`isProcessParameterOf`	relation between a process parameter and a planned process indicating that the parameter is monitored or controlled during the execution of that planned process

Changed

Classes

`CriticalQualityAttributeSpecification`

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

Annotations

explanatoryNote = “1) From ICH: critical quality attribute is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. The deviations of CQAs beyond defined limits have significant adverse impacts on product quality and, therefore, mandate stringent control, monitoring, and validation measures. 2) This specification serves as a formal constraint on a quality attribute that is critical to product performance, safety, or efficacy, and is used to assess the acceptability of materials or products in manufacturing and quality control processes. 3) Critical quality attributes are monitored throghout the manufacturing process and as such are measured on attributes of both final products and intermediate materials generated or used during the product production process .”
naturalLanguageDefinition = “quality attribute specifications that prescribes some quality, capability, constitution, or composition deemed critical to ensuring safety, efficacy, or performance of a material product”@en-US

explanatoryNote = “1) From ICH: critical quality attribute is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. The deviations of CQAs beyond defined limits have significant adverse impacts on product quality and, therefore, mandate stringent control, monitoring, and validation measures. 2) This specification serves as a formal constraint on a quality attribute that is critical to product performance, safety, or efficacy, and is used to assess the acceptability of materials or products in manufacturing and quality control processes. 3) Critical quality attributes are monitored throughout the manufacturing process and as such are measured on attributes of both final products and intermediate materials generated during the product production process.”
naturalLanguageDefinition = “quality attribute specification that prescribes some quality, capability, constitution, or composition deemed critical to ensuring the safety, efficacy, or performance of a material product”@en-US

`KeyPerformanceIndicator`

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

Annotations

firstOrderLogicDefinition = “KeyPerformanceIndicator(x) ↔ ∃s(KeyPerfornanceIndicatorSpecification(s) ∧ prescribedBy(x, s)) ∧ (TemporalRegion(x) ∨ ProcessProfile(x) ∨ Quality(x) v ProcessCharacteristic(x))”
semiFormalNaturalLanguageDefinition = “every instance of ‘key performance indicator’ is defined as exactly an instance that is either a ‘temporal region’ or a ‘process profile’ or ‘quality’ or ‘process characterstic’ and that is ‘prescribed by’ some ‘key performance indicator specification’”

firstOrderLogicDefinition = “KeyPerformanceIndicator(x) ↔ ∃s (KeyPerformanceIndicatorSpecification(s) ∧ prescribedBy(x, s)) ∧ (TemporalRegion(x) ∨ ProcessProfile(x) ∨ Quality(x) ∨ ProcessCharacteristic(x))”
semiFormalNaturalLanguageDefinition = “every instance of ‘key performance indicator’ is defined as exactly an instance that is either a ‘temporal region’, ‘process profile’, ‘quality’, or ‘process characteristic’ and that is ‘prescribed by’ some ‘key performance indicator specification’”

`KeyPerformanceIndicatorSpecification`

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

Annotations

example = “Target final harvest titer for the production batch;Target viral clearance log reduction value for purification step; Target batch release time within specified regulatory window”
explanatoryNote = “1) Per the ISO-22400 standard a good KPI has certain criteria which ensure its usefulness in achieving various goals in the manufacturing operation. For more details the user should take a look at the standard. Also the KPI specification should contain information about its context, including timing, audience, production methodology, effect model diagram, and notes. 2) In case of KPIs for (bio)pharmaceutical manufacturing processes KPIs are indirectly related to CQAs and therefore influenced, as well, by the CPPs. As the CPPs remain within the pre-defined limits, the KPIs should indicate that each production step proceeds accordingly resulting, in the end, in a product having its CQAs within the appropriate limits, too. Also, KPIs reflects the consistency or reproducibility of the associated manufacturing process.”

example = “final harvest titer specification for the production batch, measured in pooled harvested cell culture fluid at completion of harvest, with a target range of 3.5 to 5.0 grams per liter; viral clearance log reduction value specification for the purification step, calculated from the viral loads measured before and after the step, with a target of at least 4.0; batch release cycle time specification for the production batch, measured from completion of manufacturing to authorization of the batch for release, with a target of no more than 10 calendar days”
explanatoryNote = “1) Per the ISO-22400 standard a good KPI has certain criteria which ensure its usefulness in achieving various goals in the manufacturing operation. For more details the user should take a look at the standard. Also the KPI specification should contain information about its context, including timing, audience, production methodology, effect model diagram, and notes. 2) In (bio)pharmaceutical manufacturing, some process-focused KPIs may be related to CQAs and influenced by CPPs. Such KPIs can provide evidence of process consistency, reproducibility, or performance and can support assessment of whether manufacturing steps are proceeding as expected. Other KPIs may address operational performance, such as throughput, cycle time, equipment utilization, or schedule adherence, without being directly related to CQAs or CPPs.”

`KeyProcessParameter`

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

Annotations

naturalLanguageDefinition = “process profile or temporal region or quality prescribed by a key process parameter specification”@en-US

naturalLanguageDefinition = “process profile, temporal region, or quality prescribed by a key process parameter specification”@en-US

`PerformanceIndicator`

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

Annotations

firstOrderLogicDefinition = “PerformanceIndicator(x) ↔ ∃s(PerfornanceIndicatorSpecification(s) ∧ prescribedBy(x, s)) ∧ (TemporalRegion(x) ∨ ProcessProfile(x) ∨ Quality(x) v ProcessCharacteristic(x))”
semiFormalNaturalLanguageDefinition = “every instance of ‘performance indicator’ is defined as exactly an instance that is either a ‘temporal region’ or a ‘process profile’ or ‘quality’ or ‘process characterstic’ and that is ‘prescribed by’ some ‘performance indicator specification’”

firstOrderLogicDefinition = “PerformanceIndicator(x) ↔ ∃s (PerformanceIndicatorSpecification(s) ∧ prescribedBy(x, s)) ∧ (TemporalRegion(x) ∨ ProcessProfile(x) ∨ Quality(x) ∨ ProcessCharacteristic(x))”
semiFormalNaturalLanguageDefinition = “every instance of ‘performance indicator’ is defined as exactly an instance that is either a ‘temporal region’, ‘process profile’, ‘quality’, or ‘process characteristic’ and that is ‘prescribed by’ some ‘performance indicator specification’”

`PerformanceIndicatorSpecification`

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

Annotations

example = “Target sales this year, target throughput this month, taraget overall equipment effectiveness this quarter, target 12-month on-time delivery percentage.”
adaptedFrom = “https://database.ich.org/sites/default/files/Q10%20Guideline.pdf”
usageNote = “Measurable characteritics in this case can be some quality, temporal region, process profile or process characteristic which is reflected in the axiom.”

example = “annual sales revenue specification for the organization for the applicable fiscal year, with a target of at least USD 10 million; monthly production throughput specification for the manufacturing line, expressed as conforming units completed per operating hour, with a target range of 120 to 150 units per hour; quarterly overall equipment effectiveness specification for the production line, calculated as availability multiplied by performance multiplied by quality, with a target of at least 85 percent; rolling 12-month on-time delivery percentage specification for customer orders, calculated from orders delivered on or before the committed delivery date relative to the applicable orders in the reporting period, with a target of at least 95 percent”
adaptedFrom = “https://database.ich.org/sites/default/files/Q10%20Guideline.pdf and ISO 22400”
usageNote = “Measurable characteristics in this case can be some quality, temporal region, process profile or process characteristic which is reflected in the axiom.”

`ProcessParameterSpecification`

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

Annotations

example = “agitation speed specification for the mixing process in a cell culture step; incubation time specification for the cell expansion process; temperature specification for the fermentation process; flow rate specification for the loading phase of a chromatography process; pH specification for the neutralization process in buffer preparation; and residence time specification for the viral inactivation process”
explanatoryNote = “1) Process parameters must be defined with its target value or acceptable range. A process parameter may be critical or non-critical. 2) Ranges for process parameters are established during process development, and changes to operating ranges will be managed within the quality system. 3) Process parameters are used to describe and control the conditions under which a process operates, ensuring that the process achieves its intended results. 4) Process parameters are essential for defining how a process should be carried out and are typically specified in process documentation or recipes. They provide the necessary details for operators and control systems to maintain the process within desired conditions, supporting consistent product quality and process performance.”
primitiveRationale = “There are insufficient constructs to represent monitorable and controlable.”

example = “agitation speed specification for the mixing process in a cell culture step; incubation time specification for the cell expansion process; temperature specification for the fermentation process; flow rate specification for the loading phase of a chromatography process; pH specification for the neutralization process in buffer preparation; residence time specification for the viral inactivation process”
explanatoryNote = “1) Process parameters must be specified with their target value or acceptable range. A process parameter may be critical or non-critical. 2) Ranges for process parameters are established during process development, and changes to operating ranges will be managed within the quality system. 3) Process parameters are used to describe and control the conditions under which a process operates, ensuring that the process achieves its intended results. 4) Process parameters are essential for defining how a process should be carried out and are typically specified in process documentation or recipes. They provide the necessary details for operators and control systems to maintain the process within desired conditions, supporting consistent product quality and process performance.”
primitiveRationale = “There are insufficient constructs to represent monitorable and controllable.”

`QualityAttribute`

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

Annotations

example = “content uniformity of the dosage units in a batch; level of degradation products in the formulation; residual solvent level in the final product; rate or extent of drug release; dissolution capability dosage form; moisture content of the drug product; microbial load in the final product; color of the tablet or capsule; shape of the dosage form; size of the finished unit; odor of the drug product;”

example = “content uniformity of the dosage units in a batch; level of degradation products in the formulation; residual solvent level in the final product; dissolution capability of a dosage form; moisture content of the drug product; microbial load in the final product; color of the tablet or capsule; shape of the dosage form; size of the finished unit; odor of the drug product;”

`QualityAttributeSpecification`

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

Annotations

adaptedFrom = “https://www.biophorum.com/wp-content/uploads/bp_downloads/CPV-Case-Study-Interactive-Version.pdf “https://pmc.ncbi.nlm.nih.gov/articles/PMC4070262/pdf/12248_2014_Article_9598.pdf”
semiFormalNaturalLanguageAxiom = “if x is a ‘quality attribute specification’ then x is an ‘output objective specification’ and x ‘prescribes’ some ‘quality’ or ‘capability’ that ‘inheres in’ either: some ‘material entity’ that is ‘continuant part of at all times’ some ‘process intermediate material’ or ‘material product’, or that same ‘process intermediate material’ or ‘material product”
usageNote = “These specifications may refer to intrinsic physical or chemical properties (such as pH or viscosity), to capabilities (such as binding affinity), or to the identity and proportion of distinguishable components (such as glycoforms, excipients, or host cell proteins). In cases where constitution or composition is relevant, the specification typically should me modeled as a quality that inheres in a continuant part of the material, such as the concentration or proportion of a specific component which is the ‘quality of’ (inheres in) that specific component.”

adaptedFrom = “https://www.biophorum.com/wp-content/uploads/bp_downloads/CPV-Case-Study-Interactive-Version.pdf and https://pmc.ncbi.nlm.nih.gov/articles/PMC4070262/pdf/12248_2014_Article_9598.pdf”
semiFormalNaturalLanguageAxiom = “if x is a ‘quality attribute specification’ then x is an ‘output objective specification’ that ‘prescribes’ some ‘quality’ or ‘capability’ q that either ‘inheres in’ some ‘process intermediate material’ or ‘material product’ m, or ‘inheres in’ some ‘material entity’ z that is a ‘continuant part of at all times’ m”
usageNote = “These specifications may refer to intrinsic physical or chemical properties (such as pH or viscosity), to capabilities (such as binding affinity), or to the identity and proportion of distinguishable components (such as glycoforms, excipients, or host cell proteins). In cases where constitution or composition is relevant, the specification typically should be modeled as a quality that inheres in a continuant part of the material, such as the concentration or proportion of a specific component which is the ‘quality of’ (inheres in) that specific component.”

Axioms

SubClassOf: constr:prescribes some ((bfo:quality or constr:Capability) and bfo:inheres_in some (bfo:material_entity and bfo:continuant_part_of_at_all_times some (constr:ProcessIntermediateMaterial or constr:MaterialProduct))) or constr:prescribes some ((bfo:quality or constr:Capability) and bfo:inheres_in some (constr:ProcessIntermediateMaterial or constr:MaterialProduct))

SubClassOf: constr:prescribes some ((bfo:quality or constr:Capability) and bfo:inheres_in some (bfo:material_entity and bfo:continuant_part_of_at_all_times some (constr:MaterialProduct or constr:ProcessIntermediateMaterial))) or constr:prescribes some ((bfo:quality or constr:Capability) and bfo:inheres_in some (constr:MaterialProduct or constr:ProcessIntermediateMaterial))