The CLSI has published 'Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs; Approved Guideline (I/LA34-A)'.
The document provides guidance for the design, validation, analytical performance and quality assurance of laboratory assays used in the measurement of human immunoglobulin E (IgE) antibodies specific for new biotherapeutic drugs.
When a new drug is developed and evaluated in clinical trials, pharmaceutical companies establish assays early in the drug development process to monitor subjects for possible drug immunogenicity.
The development of a drug-specific antibody response is used as the principal indicator for a drug's ability to induce a humoral immune response in humans.
However, development of an assay to detect human IgE antibodies is more demanding than its companion drug-specific immunoglobulin G (IgG) antibody assay.
To this end, I/LA34 from the Clinical and Laboratory Standards Institute (CLSI) addresses the technical challenges associated with the development of this type of assay, which detects drug-specific IgE antibody in human blood and tissue extracts.
It also provides an approach for validation of an assay in the absence of a positive drug-specific human IgE antibody serum, which involves a feasibility study phase and then development and validation, using a concomitantly established drug-specific human IgG antibody assay as part of its quality control programme.
The guideline is intended to complement existing comprehensive immunogenicity (IgG assay)-based recommendations by selectively addressing unique aspects of therapeutic drug-specific human IgE antibody assay development, validation and performance specifications.
Where possible, validation techniques presented in the IgG antibody documents are used to minimise redundancy.
I/LA34 is designed for use by academic and industrial laboratory scientists and clinicians, and drug manufacturers.
This includes those who are involved in generating preclinical data and performing clinical trials involving new biotherapeutic drugs.
