Changes in π’ Manufacturing Execution Ontology
- Maturity: π’ Released
New ontology in this release, review all classes: π’ Manufacturing Execution Ontology
Added
Classes
| Construct | Definition |
|---|---|
BiomanufacturingProductionProcess | manufacturing process in which biological entities such as cells, enzymes, or organisms are used to synthesize, secrete, accumulate, or themselves serve as the target product |
CaptureStep | purification process in which target molecules are selectively and reversibly retained while impurities are allowed to pass through in the flowthrough or wash fractions |
CellBanking | storage process of preserving and maintaining cell lines for future use |
CellCultureExpansionProcess | planned process in which cells within a cell culture proliferate, resulting in an increase in the total cell number |
CellLineDevelopment | manufacturing process in which a cell line is engineered to produce a therapeutic biomolecule or biologic |
CellPopulationProliferation | process in which cells reproduce or multiply, resulting in an increase in the number of cells |
CentrifugationProcess | planned process in which particles such as cells, organelles, or molecules are separated based on size or density by applying centrifugal forces generated by a spinning rotor |
ChemicalSynthesisProcess | manufacturing process in which one or more chemical compounds are created through a set of chemical reactions |
ChromatographyProcess | planned process that results in the separation of components in a mixture based on their distribution between two phases, one of which is stationary and the other moves in a definite direction |
CloneSelectionProcess | planned processs in which an optimal set of cell clones is identified and isolated based on the clones exibiting desirable characteristics |
CloneStabilityStudy | planned process composed of one or more measurement or monitoring processes, designed to evaluate whether a selected cell clone maintains its key phenotypic characteristics, genotypic traits, and genetic integrity over time and across multiple generations of cell division |
DepthFiltrationProcess | filtration process in which a fluid is passed through a depth filter |
DiafiltrationProcess | planned process that consists of either multiple cycles of dilution followed by filtration, or of dilution and filtration occurring simultaneously, to remove unretained solutes or to exchange the solutionβs solvent or buffer environment |
DilutionProcess | solution preparation process in which a solvent is added to a solution to reduce the concentration of one or more solutes |
DirectFlowFiltration | filtration in which the fluid travels in the direction that is perpendicular to the surface of the filter |
DrugProductFormulationProcess | manufacturing process in which various components are combined to create a drug product that is safe, effective, and stable for patient use |
FiltrationProcess | planned process in which suspended solids or dissolved components are separated from a fluid by passing it through a filter |
FluidFlowOrientation | process profile that is the orientation of fluid movement in a process with respect to a reference surface or spatial axis |
GasChromatographyProcess | chromatography process in which the phase moving in a definite direction (mobile phase) is a gas |
GeneticTransformationProcess | planned process that results in the introduction, alteration, or integration of genetic material into a cell or organism |
HarvestingProcess | purification process that has as input the specified output of a biomanufacturing production process and that results in the separation or recovery of biotechnology products from the associated process streams, typically through the isolation or removal of cells, cell debris, or other bulk impurities |
LiquidChromatographyProcess | chromatography process in which the phase moving in a definite direction (mobile phase) is a liquid |
MediaSolutionPreparation | solution preparation process in which a media powder, an input media solution, or individual media components are dissolved or diluted in water or a buffered solution to produce a media solution that satisfies the material input specification of a target process |
MembraneFiltrationProcess | filtration process in which a fluid is passed through a membrane |
NanofiltrationProcess | filtration process in which a membrane filter that is used has pore size in the range of 0.001 to 0.01 ΞΌm |
NormalPhaseChromatographyProcess | liquid chromatography process in which the stationary phase is polar and the mobile phase is nonpolar, resulting in the separation of components based on their relative polarity |
PerpendicularlFlowOrientation | fluid flow orientation that is the perpendicular (normal) orientation of fluid movement in a process with respect to a defined surface |
PolishingProcess | purification process in which minute amounts of impurities are removed and that occurs as one of the final processes of drug substance manufacturing process |
PoolingProcess | manufacturing process in which two or more batches of a product or intermediate are combined to produce a single, larger volume that is more homogenous |
ProductionCultureProcess | biomanufacturing production process during which a cell culture synthesizes, secretes, or accumulates the target product in a controlled environment provided by a bioreactor following expansion in a seed train |
PurificationProcess | manufacturing process in which an input material is separated into multiple output fractions, such that one or more fractions are enriched in a target component, while the remaining fractions contain predominantly impurities and are discarded or excluded from further use |
RecipeProcessActionOccurrence | planned process that is prescribed by some recipe process action |
RecipeProcessElementOccurrence | planned process that is prescribed by some recipe process element |
RecipeProcessOccurrence | planned process that is prescribed by some recipe process |
RecipeProcessOperationOccurrence | planned process that is prescribed by some recipe process operation |
RecipeProcessStageOccurrence | planned process that is prescribed by some recipe process stage |
ReversePhaseChromatographyProcess | liquid chromatography process in which the stationary phase is nonpolar and the mobile phase is polar resulting in the separation of components based on their relative hydrophobicity |
SeedTrain | manufacturing process composed of a sequence of cell culture expansion processes occurring at increasing scales and that has as its specified output a cell culture at the required density to inoculate a production culture process |
SolutionPreparationProcess | planned process in which a homogeneous mixture is created by dissolving one or more solutes in a solvent, or by diluting an existing solution with additional solvent |
TangentialFlowFiltration | filtration process in which the liquid travels tangentially across the surface of the membrane or bed filter |
TangentialFlowOrientation | fluid flow orientation that is the tangential orientation of fluid movement in a process with respect to a defined surface |
ThawingProcess | planned process in which the temperature of a material entity is raised in a controlled manner to specified setpoint, typically to transition it from a solid or frozen state to a soft or liquid state |
TransfectionProcess | genetic transformation process of introducing DNA or RNA into eukaryotic cells by non-viral methods to modify the cellβs genetic material |
UltrafiltrationProcess | filtration process in which a membrane filter that is used has pore size in the range of 0.01 to 0.1 ΞΌm |
ViralClearance | manufacturing process that results in the elimination of a target virus by either removing viral particles or by inactivating its infectivity |
ViralFiltration | viral removal process in which viral particles are physically separated from the input material through a nanofiltration process |
ViralInactivation | viral clearance during which viral infectivity is reduced by physically or chemically modifying the input material |
ViralRemovalProcess | viral clearance during which viral particles are physically separated from the input material based on differences in physical properties such as size or charge |