🟢 Biopharma Parameter Ontology

Maturity: 🟢 Released

IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/

This module contains terms and relations necessary for representing process intermediate and product quality attributes, process indicators and process parameters.

Annotations

Contributor

Adlane Rebai, Millipore Sigma
Ana Nikolov, OAGi
Boonserm Kulvatunyou, NIST
Cameron Gibbs, CrownPoint Technologies, LLC
Gabriela Henning, NIST
Jan Kemper, AstraZeneca
Marie-Aude Coutouly, Millipore Sigma
Melissa Weller, CrownPoint Technologies, LLC
Milos Drobnjakovic, OAGi
Stephen J. Granite, CrownPoint Technologies, LLC
Stephen Kahmann, CrownPoint Technologies, LLC

Copyright

Creator

NIIMBL BD-1 Ontology Group

License

http://opensource.org/licenses/MIT

Title

NIIMBL Parameter Ontology

Classes (49)

Class	Definition
agitation rate	rate process profile at which imposed motion is applied to agitate a material
biological activity	capability of a drug substance, drug product, or relevant process intermediate material to achieve a defined biological effect
biomass specific productivity	manufacturing process productivity whose magnitude is normalized by biomass mass
biomolecule primary structure	quality of a DNA, RNA, peptide, or protein molecule that is determined by the linear order of its nucleotide or amino acid residue…
carbon dioxide evolution rate	rate process profile at which carbon dioxide is produced by cells within a cell culture
cell culture doubling time	temporal interval over which the size of a cell population doubles
cell population growth rate	population growth rate of a cell population with respect to change in its number of cells
cell specific productivity	manufacturing process productivity whose magnitude is normalized by cell amount, typically viable cell amount
critical material attribute	quality or capability that is prescribed by an input critical material attribute specification
critical process parameter	process profile or temporal region or quality prescribed by a critical process parameter specification
critical process parameter specification	process parameter specification that prescribes a variable which has an impact on a critical quality attribute
critical quality attribute	quality or capability prescribed by a critical quality attribute specification
critical quality attribute specification	quality attribute specification that prescribes some quality, capability, constitution, or composition deemed critical to ensuring…
culture split ratio	ratio of a source cell culture to one or more resulting cell cultures established from that source culture during passaging
dissolution rate	rate process profile at which a solute dissolves in a solvent
drug potency	quality of a drug substance, drug product, or relevant process intermediate material that is the quantitative degree of its biolog…
flow rate	rate process profile at which material is transported across a specified surface or boundary
input critical material attribute specification	input material attribute specification that prescribes some quality, capability, constitution, or composition whose variation can …
input material attribute	quality or capability that is prescribed by an input material attribute specification
input material attribute specification	input specification that prescribes some quality, capability, constitution, or composition of an input material that can have an i…
key performance indicator	process profile, temporal region, quality or process characteristic prescribed by a key performance indicator specification
key performance indicator specification	performance indicator specification that prescribes a measurable characteristic whose measurements reflect effectiveness with resp…
key process parameter	process profile, temporal region, or quality prescribed by a key process parameter specification
key process parameter specification	process parameter specification that prescribes a variable which must be tightly controlled to ensure process consistency and that…
manufacturing process productivity	rate process profile at which process intermediate material or material product is produced in a manufacturing process under speci…
mass flow rate	flow rate whose magnitude is determined by the mass of material transported across the specified surface or boundary per unit of e…
metabolite uptake rate	rate process profile at which a metabolite is taken up by cells within a cell culture
normalized flow rate	flow rate whose magnitude is expressed relative to a specified reference quantity
oxygen uptake rate	rate process profile at which oxygen is consumed by cells within a cell culture
performance indicator	process profile, temporal region, quality or process characteristic prescribed by a performance indicator specification
performance indicator specification	information content entity that prescribes some measurable characteristic whose measurements reflect the effectiveness of an agent…
planned process yield	process characteristic that is the ratio of a specified output quantity produced in a planned process to a specified reference qua…
population growth rate	rate process profile that captures change in the size of a population per unit of elapsed time
process parameter	process profile or temporal region or quality prescribed by a process parameter specification
process parameter specification	information content entity that prescribes a monitorable or controllable variable associated with some planned process
product titer	concentration of a process intermediate material or material product that is determined by the amount of a target product in that …
protein secondary structure	physical structure of a protein that is the local three-dimensional arrangement of segments of its polypeptide backbone, commonly …
protein tertiary structure	physical structure of a protein that is the overall three-dimensional arrangement arising from the conformation of its polypeptide…
quality attribute	quality or capability that is prescribed by a quality attribute specification
quality attribute specification	output objective specification that prescribes some quality, capability, constitution, or composition that a material product or p…
rate process profile	process profile that captures variation in an attribute of a process or one of its participants per unit of elapsed time
specific cell population growth rate	cell population growth rate whose magnitude is normalized by the size of that cell population
total material added	process characteristic that is the total quantity of a particular material that is added during a particular process
vessel volumes per day	normalized flow rate whose magnitude is the volume of medium exchanged per day relative to the working volume
volumetric flow rate	flow rate whose magnitude is determined by the volume of material transported across the specified surface or boundary per unit of…
volumetric productivity	manufacturing process productivity whose magnitude is normalized by a specified reference volume of process material
working volume	volume that is a quality of process material and that is the volume occupied by that process material in a vessel during a planned…
yield per biomass	planned process yield that characterizes the quantity of a specified material output produced in a planned process relative to the…
yield per substrate	planned process yield that characterizes the quantity of a specified material output produced in a planned process relative to the…

Object Properties (4)

Property	Definition
has performance indicator	relation between an agent, planned process, organization, or piece of equipment and a performance indicator indicating that measur…
has process parameter	relation between a planned process and a process parameter indicating that the parameter is monitored or controlled during the exe…
is performance indicator of	relation between a performance indicator and an agent, planned process, organization, or piece of equipment indicating that measur…
is process parameter of	relation between a process parameter and a planned process indicating that the parameter is monitored or controlled during the exe…