pooling process
IRI: https://spec.industrialontologies.org/ontology/construct/PoolingProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
SubClass Of: manufacturing process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › pooling process
Definition
manufacturing process in which two or more batches of a product or intermediate are combined to produce a single, larger volume that is more homogeneous
Explanatory Notes
1) This process is typically employed to reduce batch-to-batch variability or to ensure consistent quality attributes before further processing or final release. 2) Pooling can be used to define a lot of material for further processing or release, ensuring a consistent product stream. 3) Not to be confused with Test pooling, which is a testing strategy where individual samples are combined into a single pooled sample for initial testing. If the pooled sample tests negative/correct, all individuals in the pool are considered negative/correct. If the pooled sample tests positive/out of specification, individual samples within the pool are then re-tested to identify the positive/out of specification individual(s). This method is used to reduce testing costs and resources, particularly when dealing with a large number of samples and a low prevalence of the target condition.
Examples
- A monoclonal antibody manufacturing process runs four separate 2,000 L bioreactor batches in parallel. The clarified harvests from each batch are then pooled into a single lot to ensure consistent quality before downstream processing; After completing viral inactivation and polishing chromatography for three monoclonal antibody production batches, the resulting drug substance pools are combined into a single lot prior to ultrafiltration and diafiltration.
Counter-Examples
- combining individual patient samples for pooled testing in a diagnostic laboratory; mixing raw material samples solely for analytical testing purposes; combining process waste streams for disposal; preparing a media solution by mixing multiple components (not batches); combining excipients during drug formulation without prior batch identity;
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
Insufficient constructs are present to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
PoolingProcess(x) → ∃m1∃m2(((MaterialProduct(m1) ∨ ProcessIntermediateMaterial(m1)) ∧ (MaterialProduct(m2) ∨ ProcessIntermediateMaterial(m2))) ∧ hasInput(x,m1) ∧ hasInput(x,m2) ∧ m1 ≠ m2)
Semi-Formal Natural Language Axioms
if x is a ‘pooling process’ then x ‘has input’ at least two distinct entities that are each a ‘material product’ or ‘process intermediate material’