π’ Biopharma Material Ontology
Maturity: π’ Released
IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
This module contains terms and relations enabling representation of material types and their associated properties. Terms for characterizing material usages in internal operation systems are also included (e.g., consumable, process intermediate, final productβ¦).
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
Copyright (c) 2022, 2023, 2024, 2025, 2026 Open Applications Group
Creator
NIIMBL BD-1 Ontology Group
License
http://opensource.org/licenses/MIT
Title
NIIMBL Material Ontology
Classes (148)
| Class | Definition |
|---|---|
| acidifying agent role | pH adjusting agent role of a material entity when it is used, or planned to be used, to lower pH |
| alkalizing agent role | pH adjusting agent role of a material entity when it is used, or planned to be used, to raise pH |
| amount of substance | quality of a material entity that is proportional to the number of elementary entities of a particular kind present in that materi⦠|
| antifoaming agent | material entity with an antifoaming agent role |
| antifoaming agent role | role of a material entity when it is used, or planned to be used, to reduce or prevent foam formation in a liquid |
| bacterium cell | cell that lacks a membrane-bound nucleus and has ribosomes of the bacterial type |
| basal culture medium | culture medium which has the basal culture medium role |
| basal culture medium role | role held by a culture medium when it is used or planned to be used either directly in a cell culture process to provide essential⦠|
| bioburden | relational quality of a material entity that is the extent to which viable microorganisms are present in or on the surface of the β¦ |
| bioproduction supporting function | culture medium specialized function that enables the generation of a target biological product by sustaining cellular activity und⦠|
| buffer solution | solution consisting of a mixture of a weak acid and its conjugate base or a weak base and its conjugate acid which is resistant to⦠|
| buffering agent role | role of a material entity when it is added or planned to be added to a mixture, typically aqueous, to enable or enhance the mixtur⦠|
| buffering capability | capability of a solution to resist a change in pH when acid or base is added |
| buffering function | function of a solution to resist a change in pH when an acid or base is added |
| bulk density | mass density of a particulate material that is the mass per total bulk volume occupied by the material, where the total bulk volum⦠|
| caking propensity | disposition of a particulate material entity to form persistent lumps, agglomerates, or a coherent solid mass |
| carbon source role | nutrient role held by a material entity that provides carbon used by an organism or cell for biosynthesis, energy generation, or b⦠|
| cell | object of anatomical origin (part of or deriving from an organism) that has as its parts a maximally connected cell compartment su⦠|
| cell bank | object aggregate consisting of containers whose contents are uniform portions derived from a single pool of cells and that are sto⦠|
| cell count | count that is the number of cells that are present as parts of a material entity |
| cell culture | material entity that has cultured cells and the media in which they are being propagated or stored as parts |
| cell culture derived impurity role | manufacturing process related impurity role held by a material entity that originates from an acellular material component of a ce⦠|
| cell density | number density that is the number of cells per unit size |
| cell line | cultured cell population that is derived from a primary cell source and that has been propagated through repeated subculture under⦠|
| cell line lineage | history of the development of a cell line |
| cell population | object aggregate which only has cells as its member parts |
| cell proliferation supporting function | specialized culture medium function that supports cell division and maintenance of cell viability during expansion culture by prov⦠|
| cell substrate derived impurity role | manufacturing process related impurity role held by a material entity that originates from cells used in a manufacturing process |
| cell viability ratio | relative abundance that is the number of viable cells in a cell population relative to the total number of cells in that populatio⦠|
| chemical substance material | material entity that is made primarily of one kind of molecular entity, allowing for minor impurities |
| chemically defined culture medium | serum free culture medium in which each component and its concentration are known and reproducible, and that excludes undefined co⦠|
| cloned cell line | cell line that originates from a single ancestral cell |
| compendial grade classifier | material grade classifier that classifies a material entity as conforming to the requirements stated in an applicable pharmacopeia⦠|
| complete culture medium | culture medium which has the complete culture medium role |
| complete culture medium role | role held by a culture medium when it is used or planned for direct use in a cell culture process to meet the full set of nutritio⦠|
| concentration | relational quality of a mixture that is the amount of substance or number or mass or volume of a specified constituent of the mixt⦠|
| contaminant role | material impurity role held by a material entity when it is adventitiously introduced during a manufacturing process |
| cryoprotective agent role | protective agent role of a material entity when it is used, or planned to be used, to protect one or more other material entities β¦ |
| culture medium | mixed material that is a liquid, semi-solid or solid formulation that provides essential nutrients (such as carbon, nitrogen, vita⦠|
| culture medium supplement | material entity that has a culture medium supplement role |
| culture medium supplement role | material component role held by a material entity when it is added or planned to be added to culture media to enrich or modify the⦠|
| culture preservation function | culture medium specialized function that maintains cell viability and structural integrity during storage and transport by providi⦠|
| cultured cell | cell that is grown, maintained, or adapted to grow in a controlled artificial environment that supports its survival and prolifera⦠|
| cultured cell population | cell population which only has cultured cells as its member parts |
| dead | viability status of a biological material entity that has irreversibly ceased to maintain the biological processes characteristic β¦ |
| dead cell count | cell count that is the number of dead cells that are present as parts of a material entity |
| dead cell density | cell density that is the number of dead cells per unit size |
| dead cell population | cell population consisting of only dead cells |
| dissolution role | role held by a material entity that is realized in a dissolution process in which it participates in forming a solution |
| dissolved oxygen saturation ratio | solution saturation ratio that is the dissolved oxygen concentration in a liquid solution relative to the dissolved oxygen saturat⦠|
| downstream derived impurity role | manufacturing process related impurity role held by a material entity that originates from a raw material, production consumable, β¦ |
| dusting propensity | disposition of a particulate material entity to generate airborne particulate matter during handling or processing |
| emulsion propensity | disposition of a material entity to form an emulsion |
| energy substrate role | nutrient role held by a material entity that is metabolized in cellular pathways to generate adenosine triphosphate, reducing equi⦠|
| equilibrium saturation concentration | solution saturation concentration of a particular solute at thermodynamic equilibrium |
| expansion culture medium | specialized culture medium that has a cell proliferation supporting function |
| extractable and leachable impurity role | material impurity role held by a material entity in virtue of that material entity being present in a target material as a result β¦ |
| filterability | capability of a fluid to pass through a filtration medium without undue blockage or loss of permeability |
| flowability | capability of a material entity to move by flow |
| foamability | capability of a liquid to form foam during a particular process |
| hygroscopicity | capability of a material entity to attract and hold moisture from the surrounding environment |
| impurity fraction | fraction of a material entity that is determined by the proportion of material considered an impurity relative to the material ent⦠|
| infected host cell | cell that is infected by a virus or another type of microorganism |
| inoculum role | role held by a material entity containing biological material when it is being added, or is planned to be added, to initiate or es⦠|
| intact molecular mass | molecular mass of a molecular entity or molecular entity population considered in its whole, intact form, without fragmentation, c⦠|
| intermediate stock solution role | stock solution role held by a solution when the solution is prepared by diluting another stock solution and is used, or planned to⦠|
| isoelectric point | electrical quality of a molecular entity that corresponds to the pH of a homogeneous aqueous mixture at which that molecular entit⦠|
| manufacturing process related impurity role | material impurity role held by a material entity that is present in a process intermediate material or material product and whose β¦ |
| mass concentration | concentration that is the mass of a specified constituent of a mixture per unit volume of that mixture |
| master cell bank | cell bank produced in a single preparation event from a well-characterized cell line or clone, stored under validated cryogenic co⦠|
| material differentiation inducer | material entity with a material differentiation inducer role |
| material differentiation inducer role | role held by a material entity when it is used, or planned to be used to activate signaling pathways that drive cell fate decision⦠|
| material functional inducer | material entity with a material functional inducer role |
| material functional inducer role | role held by a material entity when it is used, or planned to be used, to trigger, enhance, or repress a specified cellular activi⦠|
| material grade classifier | classifier that classifies a material entity into an organization- or authority-defined material grade based on the material entit⦠|
| material metabolic inducer | material entity with a material metabolic inducer role |
| material metabolic inducer role | role held by a material entity when it is used, or planned to be used to activate expression of enzymes or pathways involved in th⦠|
| material production inducer | material entity with a material production inducer role |
| material production inducer role | role held by a material entity when it is added, or planned to be added, to a cell culture to trigger the synthesis of a target pr⦠|
| miscibility | capability of two or more material entities to form a single homogeneous phase when combined as a mixture |
| mixed material | material entity composed of at least two material constituents that are distinct in chemical identity or material composition, exc⦠|
| moisture content | ratio that is the mass of water contained in a material entity relative to a defined reference mass of that material entity |
| molar concentration | concentration that is the amount of substance of a specified constituent of a mixture per unit volume of that mixture |
| molar mass | quality that is the quality of a molecular entity or population of molecular entities, and is either the mass of one mole of that β¦ |
| molecular carrier role | role of a material entity when it supports the transport, or delivery of one or more molecular entities in a physical, chemical, o⦠|
| molecular mass | mass that is either the mass of a molecular entity or an average of the masses of the molecular entities in a molecular entity pop⦠|
| mycoplasma cell | bacterium cell that lacks a rigid cell wall and is capable of infecting mammalian cells |
| nitrogen source role | nutrient role held by a material entity that provides nitrogen for synthesis of amino acids, nucleotides, and other nitrogen-conta⦠|
| non-glycosylated molecular mass | molecular mass of a glycoprotein or population of glycoproteins that characterizes the mass contribution of its non-glycan molecul⦠|
| nutrient feed | material entity with a nutrient feed role |
| nutrient feed role | role held by a material entity when it is added, or planned to be added, to a cell culture during cultivation or production to sup⦠|
| nutrient role | role held by a material entity that is made available to an organism or cell to support metabolism, growth, maintenance, or biomas⦠|
| osmolality | relational quality of a solution that is the amount of osmotically active solute entities in that solution per unit mass of solven⦠|
| osmolarity | relational quality of a solution that is the amount of osmotically active solute entities in that solution per unit volume of that⦠|
| partial pressure | pressure that is the contribution of a particular gaseous constituent of a gas mixture to the total pressure of that mixture |
| pH | quality of a material entity that is quantified as the negative decimal logarithm of the relative activity of hydrogen ions in tha⦠|
| pH adjusting agent role | role of a material entity when it is used, or planned to be used to adjust pH |
| pharmaceutical degradation product impurity role | pharmaceutical product related impurity role held by a material entity that differs from the targeted drug substance or drug produ⦠|
| pharmaceutical product related impurity role | material impurity role held by a material entity that is related to the targeted drug substance or drug product but is not part of⦠|
| portion of water | chemical substance material composed primarily of water molecules, allowing for minor impurities arising from production, handling⦠|
| portion of water for injection | portion of water that is classified by a water for injection classifier |
| precipitation propensity | disposition of a liquid mixed material to form an insoluble solid phase from dissolved constituents |
| preservation culture medium | specialized culture medium that has a culture preservation function |
| production culture medium | specialized culture medium that has a bioproduction supporting function |
| protective agent role | role of a material entity when it is used or planned to be used to protect one or more other material entities from stress or dama⦠|
| protein free culture medium | serum free culture medium that does not include any proteins |
| protein hydrolysate | mixed material produced by partial or extensive hydrolysis of protein-containing material and composed primarily of oligopeptides,β¦ |
| reconstitutability | capability of a dried or concentrated material entity to form a liquid mixture that satisfies specified usage requirements when co⦠|
| relative abundance | ratio that is determined by the magnitude of a specified member or subset of a defined group of material entities relative to the β¦ |
| relative humidity | saturation ratio of a gas mixture whose magnitude is the partial pressure of water vapor in that gas mixture relative to the satur⦠|
| saturated state | material state of a solution in which the dissolved solute concentration stays at the soluteβs equilibrium saturation concentratioβ¦ |
| saturation ratio | ratio of a material entity whose magnitude is the magnitude of a quality of that material entity relative to the magnitude at the β¦ |
| serum | mixed material that is obtained from blood following coagulation and removal of cells and clotting factors |
| serum containing culture medium | culture medium that contains serum |
| serum free culture medium | culture medium that contains no serum |
| shear protective agent role | protective agent role of a material entity when it is used, or planned to be used, to protect one or more other material entities β¦ |
| solubility capability | capability of a material entity to dissolve in a particular solvent |
| solute | material entity with a solute role |
| solute role | dissolution role held by a material entity that is realized in a process where it is dissolved within another substance (the solve⦠|
| solution | mixed material composed of one homogeneous phase in which constituent particles are not visible to the naked eye and that does not⦠|
| solution saturation concentration | concentration of a dissolved solute in a solution at the solubility limit of that solute under stated conditions |
| solution saturation ratio | saturation ratio of a solution whose magnitude is the concentration of a dissolved solute in that solution relative to the saturat⦠|
| solution saturation state | material state of a solution in which the dissolved solute concentration stays below, at, or above the soluteβs equilibrium saturaβ¦ |
| solvent | material entity with a solvent role |
| solvent role | dissolution role held by a material entity that is realized in a process where it dissolves another substance (the solute) to form⦠|
| specialized culture medium | culture medium that has a specialized culture medium function |
| specialized culture medium function | designed function that inheres in a culture medium and is specified to satisfy the culture requirements of a particular cell type,β¦ |
| spent culture medium state | material state of culture medium that has participated in a cell cultivation process and is characterized by compositional changes⦠|
| stock solution role | role held by a solution that is prepared with an accurately known solute concentration so that measured portions can be diluted to⦠|
| supersaturated state | solution saturation state in which the dissolved solute concentration stays above the soluteβs equilibrium saturation concentratioβ¦ |
| surface tension | quality of a liquid material entity that is the resistance of the liquid surface to an increase in surface area, arising from unba⦠|
| surfactant | material entity with a surfactant role |
| surfactant role | role of a material entity when it is used, or planned to be used, to lower the surface tension of a medium or the interfacial tens⦠|
| tapped density | mass density of a particulate material that is the mass per tapped volume occupied by the material after tapping until little or n⦠|
| total cell count | cell count that is the number of all cells present as parts of a material entity |
| total cell density | cell density that is the total number of cells per unit size |
| unsaturated state | material state of a solution in which the dissolved solute concentration stays below the soluteβs equilibrium saturation concentraβ¦ |
| viability status | quality of a biological material entity by virtue of whether that entity is alive and capable of maintaining or recovering relevan⦠|
| viable | viability status of a biological material entity that is alive and capable of maintaining or recovering relevant physiological act⦠|
| viable cell count | cell count that is the number of viable cells that are present as parts of a material entity |
| viable cell density | cell density that is the number of viable cells per unit size |
| viable cell population | cell population consisting of only viable cells |
| virus | minute infectious agent that has a DNA or RNA genome, lacks independent metabolism, and replicates only through use of a living ho⦠|
| virus seed | object aggregate consisting of containers whose contents are portions of a virus preparation derived from a single defined virus s⦠|
| water for injection classifier | compendial grade classifier that classifies a portion of water that conforms to the requirements stated in a Water for Injection p⦠|
| wettability | capability of a solid material to be wetted by a liquid |
| working cell bank | cell bank prepared from cells recovered from one or more containers of a master cell bank and stored under validated cryogenic con⦠|
| working solution role | role held by a solution when the solution is prepared from a stock solution or intermediate stock solution at the concentration re⦠|
Table of contents
- π§ acidifying agent role
- π§ alkalizing agent role
- π§ amount of substance
- π§ antifoaming agent
- π§ antifoaming agent role
- π§ bacterium cell
- π§ basal culture medium
- π§ basal culture medium role
- π§ bioburden
- π§ bioproduction supporting function
- π§ buffer solution
- π§ buffering agent role
- π§ buffering capability
- π§ buffering function
- π§ bulk density
- π§ caking propensity
- π§ carbon source role
- π§ cell
- π§ cell bank
- π§ cell count
- π§ cell culture
- π§ cell culture derived impurity role
- π§ cell density
- π§ cell line
- π§ cell line lineage
- π§ cell population
- π§ cell proliferation supporting function
- π§ cell substrate derived impurity role
- π§ cell viability ratio
- π§ chemical substance material
- π§ chemically defined culture medium
- π§ cloned cell line
- π§ compendial grade classifier
- π§ complete culture medium
- π§ complete culture medium role
- π§ concentration
- π§ contaminant role
- π§ cryoprotective agent role
- π§ culture medium
- π§ culture medium supplement
- π§ culture medium supplement role
- π§ culture preservation function
- π§ cultured cell
- π§ cultured cell population
- π§ dead
- π§ dead cell count
- π§ dead cell density
- π§ dead cell population
- π§ dissolution role
- π§ dissolved oxygen saturation ratio
- π§ downstream derived impurity role
- π§ dusting propensity
- π§ emulsion propensity
- π§ energy substrate role
- π§ equilibrium saturation concentration
- π§ expansion culture medium
- π§ extractable and leachable impurity role
- π§ filterability
- π§ flowability
- π§ foamability
- π§ hygroscopicity
- π§ impurity fraction
- π§ infected host cell
- π§ inoculum role
- π§ intact molecular mass
- π§ intermediate stock solution role
- π§ isoelectric point
- π§ manufacturing process related impurity role
- π§ mass concentration
- π§ master cell bank
- π§ material differentiation inducer
- π§ material differentiation inducer role
- π§ material functional inducer
- π§ material functional inducer role
- π§ material grade classifier
- π§ material metabolic inducer
- π§ material metabolic inducer role
- π§ material production inducer
- π§ material production inducer role
- π§ miscibility
- π§ mixed material
- π§ moisture content
- π§ molar concentration
- π§ molar mass
- π§ molecular carrier role
- π§ molecular mass
- π§ mycoplasma cell
- π§ nitrogen source role
- π§ non-glycosylated molecular mass
- π§ nutrient feed
- π§ nutrient feed role
- π§ nutrient role
- π§ osmolality
- π§ osmolarity
- π§ partial pressure
- π§ pH
- π§ pH adjusting agent role
- π§ pharmaceutical degradation product impurity role
- π§ pharmaceutical product related impurity role
- π§ portion of water
- π§ portion of water for injection
- π§ precipitation propensity
- π§ preservation culture medium
- π§ production culture medium
- π§ protective agent role
- π§ protein free culture medium
- π§ protein hydrolysate
- π§ reconstitutability
- π§ relative abundance
- π§ relative humidity
- π§ saturated state
- π§ saturation ratio
- π§ serum
- π§ serum containing culture medium
- π§ serum free culture medium
- π§ shear protective agent role
- π§ solubility capability
- π§ solute
- π§ solute role
- π§ solution
- π§ solution saturation concentration
- π§ solution saturation ratio
- π§ solution saturation state
- π§ solvent
- π§ solvent role
- π§ specialized culture medium
- π§ specialized culture medium function
- π§ spent culture medium state
- π§ stock solution role
- π§ supersaturated state
- π§ surface tension
- π§ surfactant
- π§ surfactant role
- π§ tapped density
- π§ total cell count
- π§ total cell density
- π§ unsaturated state
- π§ viability status
- π§ viable
- π§ viable cell count
- π§ viable cell density
- π§ viable cell population
- π§ virus
- π§ virus seed
- π§ water for injection classifier
- π§ wettability
- π§ working cell bank
- π§ working solution role