Standardized Extract Testing
Standardized Extract Testing at HYCOR® Biomedical for the NOVEOS™ Immunoassay System: Elevating a Common “Broth” to a More Refined “Consommé”
The Pain Point:
The quality of commercial allergen extracts differs between manufacturers.
The quality of these extracts differs across lots even from the same manufacturer.
The ramification of the variability of the quality of commercial allergen extracts is that it can limit their utility for immunotherapy.
Components Advantages: They are pure proteins and their use is advantageous both in the manufacturing of the allergy product and to obtain consistency of the preparation itself.
Component Disadvantages: Their lack of availability of clinically relevant components, increased cost of materials, additional manufacturing labor, and components could be less potent compared to corresponding whole extracts due to incorrect protein folding, protein degradation, and improper transport conditions.
Take away points:
Despite advances in the processes to manufacture better allergenic materials, most large diagnostic manufacturers have been resistant to switch to these new techniques since they are more expensive, require updated processes/procedures, but more significantly may require a change from the allergen used in original regulatory filings, which would result in the need for additional submissions and costs.
This paper reviews the extensive analytical and performance testing that HYCOR performs for each extract during the selection process of appropriate extracts for the NOVEOS™ Specific IgE tests.
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