Biopharma Manufacturing Execution Ontology
Maturity: 🟢 Released
IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
This module contains terms and relations necessary for representing the actual occurrences of manufacturing processes with respect to recipes.
Classes (43)
| Class | Definition |
|---|---|
| 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 | storage process of preserving and maintaining cell lines for future use |
| cell culture expansion process | planned process in which cells within a cell culture proliferate, resulting in an increase in the total cell number |
| cell line development | manufacturing 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 |
| 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 |
| 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 processs in which an optimal set of cell clones is identified and isolated based on the clones exibiting 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… |
| 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… |
| 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… |
| 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 |
| nanofiltration process | filtration process in which a membrane filter that is used has pore size in the range of 0.001 to 0.01 μm |
| normal phase chromatography process | liquid chromatography process in which the stationary phase is polar and the mobile phase is nonpolar, resulting in the separation… |
| perpendicular flow orientation | fluid flow orientation that is the perpendicular (normal) orientation of fluid movement in a process with respect to a defined sur… |
| polishing process | purification process in which minute amounts of impurities are removed and that occurs as one of the final processes of drug subst… |
| 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 process | biomanufacturing production process during which a cell culture synthesizes, secretes, or accumulates the target product in a cont… |
| purification process | manufacturing process in which an input material is separated into multiple output fractions, such that one or more fractions are … |
| 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… |
| 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 specified setpoint, typically to… |
| transfection process | genetic transformation process of introducing DNA or RNA into eukaryotic cells by non-viral methods to modify the cell’s genetic m… |
| ultrafiltration process | filtration process in which a membrane filter that is used has pore size in the range of 0.01 to 0.1 μm |
| viral clearance | manufacturing process that results in the elimination of a target virus by either removing viral particles or by inactivating its … |
| 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… |
Table of contents
- biomanufacturing production process
- capture step
- cell banking
- cell culture expansion process
- cell line development
- cell population proliferation
- centrifugation process
- chemical synthesis process
- chromatography process
- clone selection process
- clone stability study
- depth filtration process
- diafiltration process
- dilution process
- direct flow filtration
- drug product formulation process
- filtration process
- fluid flow orientation
- gas chromatography process
- genetic transformation process
- harvesting process
- liquid chromatography process
- media solution preparation
- membrane filtration process
- nanofiltration process
- normal phase chromatography process
- perpendicular flow orientation
- polishing process
- pooling process
- production culture process
- purification process
- reverse phase chromatography process
- seed train
- solution preparation process
- tangential flow filtration
- tangential flow orientation
- thawing process
- transfection process
- ultrafiltration process
- viral clearance
- viral filtration
- viral inactivation
- viral removal process