π’ Biopharma Manufacturing Execution Ontology
Maturity: π’ Released
IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
RDF: BiopharmaManufacturingExecution.rdf
This module contains terms and relations necessary for representing the actual occurrences of manufacturing processes with respect to recipes.
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 Manufacturing Execution Ontology
Classes (76)
| Class | Definition |
|---|---|
| aeration process | material addition process in which an oxygen-containing gas is added to a defined recipient to provide oxygen or support gas excha⦠|
| antifoam addition process | material addition process in which an antifoam agent is introduced into a defined recipient to suppress, reduce, or prevent foam f⦠|
| batch process operating mode | process operating mode of a planned process in which a finite quantity of process material is introduced before or at the start of⦠|
| biomanufacturing production process | manufacturing process in which biological entities such as cells, enzymes, or organisms are used to synthesize, secrete, accumulat⦠|
| capture step | purification process in which target molecules are selectively and reversibly retained while impurities are allowed to pass throug⦠|
| cell banking | planned process of preserving and maintaining a cell line for future use |
| cell bleed process | material removal process in which a portion of cell-containing culture material is withdrawn from a cell culture during an ongoing⦠|
| cell culture expansion process | planned cell culture process during which cultivation is managed primarily to increase the total number of cells through cell prol⦠|
| cell culture inoculation process | inoculation process in which a cell-containing inoculum is introduced to initiate a cell culture process |
| cell culture recovery process | planned process in which cells that have undergone a stress-inducing process are cultured under controlled conditions to restore o⦠|
| cell line development | planned process in which a cell line is engineered to produce a therapeutic biomolecule or biologic |
| cell population proliferation | process in which cells reproduce or multiply, resulting in an increase in the number of cells |
| cell retention process | planned process in which material is removed from a cell culture while cells are preferentially kept in or returned to the cell cu⦠|
| cell therapy production process | biomanufacturing production process that results in a cell population which constitutes the targeted product material |
| centrifugation process | planned process in which particles such as cells, organelles, or molecules are separated based on size or density by applying cent⦠|
| chemical synthesis process | manufacturing process in which one or more chemical compounds are created through a set of chemical reactions |
| chemostat culture process operating mode | continuous culture process operating mode in which culture medium containing a growth-limiting component is introduced while cultu⦠|
| chromatography process | planned process that results in the separation of components in a mixture based on their distribution between two phases, one of w⦠|
| clone selection process | planned process in which an optimal set of cell clones is identified and isolated based on the clones exhibiting desirable charact⦠|
| clone stability study | planned process composed of one or more measurement or monitoring processes, designed to evaluate whether a selected cell clone ma⦠|
| continuous culture process operating mode | continuous process operating mode of a culture process in which culture medium or other input material is introduced while culture⦠|
| continuous process operating mode | process operating mode that characterizes a planned process in which input material is introduced into the process while output ma⦠|
| culture feed addition process | material addition process in which a nutrient feed is added to a cell culture during a culture process |
| culture feeding strategy | plan specification that prescribes how one or more feeding processes are to be executed during a cell culture process, including s⦠|
| culture medium charging process | material addition process in which culture medium is added to a culture vessel in preparation for cell culture inoculation |
| culture medium exchange process | planned process in which part or all of the spent culture medium associated with a cell culture is removed and fresh culture mediu⦠|
| degassing process | planned process during which dissolved, entrained, or adsorbed gas is separated from a liquid or solid material |
| depth filtration process | filtration process in which a fluid is passed through a depth filter |
| diafiltration process | planned process that consists of either multiple cycles of dilution followed by filtration, or of dilution and filtration occurrin⦠|
| dilution process | solution preparation process in which a solvent is added to a solution to reduce the concentration of one or more solutes |
| direct flow filtration | filtration in which the fluid travels in the direction that is perpendicular to the surface of the filter |
| drug product formulation process | manufacturing process in which various components are combined to create a drug product that is safe, effective, and stable for pa⦠|
| fed batch process operating mode | process operating mode of a planned process in which a finite quantity of process material is introduced before or at the start of⦠|
| filtration process | planned process in which suspended solids or dissolved components are separated from a fluid by passing it through a filter |
| fluid flow orientation | process profile that is the orientation of fluid movement in a process with respect to a reference surface or spatial axis |
| gas chromatography process | chromatography process in which the phase moving in a definite direction (mobile phase) is a gas |
| genetic transformation process | planned process that results in the introduction, alteration, or integration of genetic material into a cell or organism |
| harvesting process | purification process that has as input the specified output of a biomanufacturing production process and that results in the separ⦠|
| induction process | planned process that is a part of a cultivation or production process and triggers a defined change in cellular function, pathway β¦ |
| inoculation process | material addition process in which cells, microorganisms, viruses, or biological preparations are deliberately introduced into a d⦠|
| liquid chromatography process | chromatography process in which the phase moving in a definite direction (mobile phase) is a liquid |
| media solution preparation | solution preparation process in which a media powder, an input media solution, or individual media components are dissolved or dil⦠|
| membrane filtration process | filtration process in which a fluid is passed through a membrane |
| mixing process | planned process that combines material entities or redistributes parts of a material entity to increase or maintain the homogeneit⦠|
| nanofiltration process | filtration process in which a membrane filter that is used has pore size in the range of 0.001 to 0.01 ΞΌm |
| normal phase chromatography process | liquid chromatography process in which the stationary phase is polar and the mobile phase is nonpolar, resulting in the separation⦠|
| perfusion culture process operating mode | continuous culture process operating mode in which culture medium or other input material is introduced while spent medium or prod⦠|
| perfusion medium exchange process | culture medium exchange process in which fresh culture medium is added to a cell culture while material is continuously or quasi-c⦠|
| perpendicular flow orientation | fluid flow orientation that is the perpendicular (normal) orientation of fluid movement in a process with respect to a defined sur⦠|
| pH adjustment addition process | material addition process in which an acidifying or alkalizing material is introduced into a defined recipient to modify pH |
| planned cell infection process | planned process in which a cell culture is exposed to a virus inoculum under defined conditions in order to generate a population β¦ |
| planned process operating mode | process characteristic of a planned process that characterizes the overall pattern by which process material is introduced into, r⦠|
| planned transduction process | genetic transformation process of introducing DNA or RNA into cells by a virus or viral vector to modify the cellβs genetic materiβ¦ |
| polishing process | purification process in which minute amounts of impurities are removed and that occurs as one of the final processes of a drug sub⦠|
| pooling process | manufacturing process in which two or more batches of a product or intermediate are combined to produce a single, larger volume th⦠|
| production culture growth phase | cell culture expansion process that is a temporal part of a production culture process |
| production culture process | biomanufacturing production process during which a cell culture synthesizes, secretes, or accumulates the target product in a cont⦠|
| production culture production phase | manufacturing process that is a temporal part of a production culture process and during which process conditions are managed prim⦠|
| purification process | manufacturing process in which an input material is separated into multiple output fractions, such that one or more fractions are β¦ |
| reverse phase chromatography process | liquid chromatography process in which the stationary phase is nonpolar and the mobile phase is polar, resulting in the separation⦠|
| seed train | manufacturing process composed of a sequence of cell culture expansion processes occurring at increasing scales and that has as it⦠|
| solution preparation process | planned process in which a homogeneous mixture is created by dissolving one or more solutes in a solvent, or by diluting an existi⦠|
| splitting process | manufacturing process in which a batch or lot of a product or intermediate is divided into two or more separately managed portions⦠|
| sterile material state | material state in which a participating material entity is free of viable microorganisms |
| sterilization process | planned process in which a material entity is rendered free of all viable microorganisms |
| tangential flow filtration | filtration process in which the liquid travels tangentially across the surface of the membrane or bed filter |
| tangential flow orientation | fluid flow orientation that is the tangential orientation of fluid movement in a process with respect to a defined surface |
| thawing process | planned process in which the temperature of a material entity is raised in a controlled manner to a specified setpoint, typically β¦ |
| transfection process | genetic transformation process of introducing DNA or RNA into eukaryotic cells by non-viral methods to modify the cellβs genetic mβ¦ |
| ultrafiltration process | filtration process in which a membrane filter that is used has pore size in the range of 0.01 to 0.1 ΞΌm |
| upstream biomanufacturing process | manufacturing process that includes preparation, expansion, cultivation, or propagation of biological material under controlled co⦠|
| viral clearance | manufacturing process that results in the elimination of a target virus by either removing viral particles or by inactivating its β¦ |
| viral filtration | viral removal process in which viral particles are physically separated from the input material through a nanofiltration process |
| viral inactivation | viral clearance during which viral infectivity is reduced by physically or chemically modifying the input material |
| viral removal process | viral clearance during which viral particles are physically separated from the input material based on differences in physical pro⦠|
| virus inoculation process | inoculation process in which a virus seed or infected host-cell-containing material is deliberately introduced into a cell culture⦠|
Table of contents
- π§ aeration process
- π§ antifoam addition process
- π§ batch process operating mode
- π§ biomanufacturing production process
- π§ capture step
- π§ cell banking
- π§ cell bleed process
- π§ cell culture expansion process
- π§ cell culture inoculation process
- π§ cell culture recovery process
- π§ cell line development
- π§ cell population proliferation
- π§ cell retention process
- π§ cell therapy production process
- π§ centrifugation process
- π§ chemical synthesis process
- π§ chemostat culture process operating mode
- π§ chromatography process
- π§ clone selection process
- π§ clone stability study
- π§ continuous culture process operating mode
- π§ continuous process operating mode
- π§ culture feed addition process
- π§ culture feeding strategy
- π§ culture medium charging process
- π§ culture medium exchange process
- π§ degassing process
- π§ depth filtration process
- π§ diafiltration process
- π§ dilution process
- π§ direct flow filtration
- π§ drug product formulation process
- π§ fed batch process operating mode
- π§ filtration process
- π§ fluid flow orientation
- π§ gas chromatography process
- π§ genetic transformation process
- π§ harvesting process
- π§ induction process
- π§ inoculation process
- π§ liquid chromatography process
- π§ media solution preparation
- π§ membrane filtration process
- π§ mixing process
- π§ nanofiltration process
- π§ normal phase chromatography process
- π§ perfusion culture process operating mode
- π§ perfusion medium exchange process
- π§ perpendicular flow orientation
- π§ pH adjustment addition process
- π§ planned cell infection process
- π§ planned process operating mode
- π§ planned transduction process
- π§ polishing process
- π§ pooling process
- π§ production culture growth phase
- π§ production culture process
- π§ production culture production phase
- π§ purification process
- π§ reverse phase chromatography process
- π§ seed train
- π§ solution preparation process
- π§ splitting process
- π§ sterile material state
- π§ sterilization process
- π§ tangential flow filtration
- π§ tangential flow orientation
- π§ thawing process
- π§ transfection process
- π§ ultrafiltration process
- π§ upstream biomanufacturing process
- π§ viral clearance
- π§ viral filtration
- π§ viral inactivation
- π§ viral removal process
- π§ virus inoculation process