Sentence examples for clearance validation from inspiring English sources

Analytical tools for process development and characterization addressed problematic in-process samples, and a viral clearance validation study was performed using adenovirus and two non-specific model viruses.

Impurity clearance validation studies demonstrated robust and reproducible removal of process-related impurities and adventitious viruses.

Process-related impurity clearance validation studies were performed both at the manufacturing scale and in scaled-down spiking studies at the laboratory scale.

Table 6 summarizes the clearance validation results for several process-related impurities, including host cell proteins, host cell DNA and recombinant protein A ligand leachate.

Scaled-down impurity clearance validation studies (performed at the laboratory scale) consisted of the addition of an impurity to the process intermediate, followed by purification of the spiked intermediate using a scaled-down chromatography step.

The clearance validation studies performed at the manufacturing scale consisted of direct measurement of the impurities obtained from the manufacturing process intermediates, in which clearance was calculated from the amount removed during the process step.

Clearance and validation were addressed by providing a draft copy of the research findings to participants for comment on how well the findings reflected their experience.

What will validation validate?

This should be taken into consideration by regulatory agencies and biologics manufacturers designing viral clearance and facility disinfection validation studies, and developers and evaluators of viral disinfectants.

Previous work have focused on the technical viability of this approach, dealing with single criterion clearance, but in an real validation phase, there are usually multiple criteria that need to be checked, therefore requiring either multiple runs of a single-objective method, or ideally a multi-objective approach.

For CYP2C19, based on OME hydroxylation; and for CYP2D6, based on DEX demethylation, validation of plasma clearance or AUC of the substrates is not superior to single-point measurements [ 28].