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Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs, 1st Edition

This document provides guidance for the design, validation, analytical performance, and quality assurance of laboratory assays used in the measurement of human immunoglobulin E antibodies specific for new biotherapeutic drugs.

This document is available in electronic format only.

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Chairholder: Robert G. Hamilton, PhD, D.ABMLI

Date of Publication: June 30, 2011

Order Code PDF: CLSI ILA34AE
ISBN Number: 1-56238-755-3

Order Code Print: print not available

Edition: First

Pages: 60

CLSI I/LA34 Additional Details

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This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of January 2017. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI I/LA34 Abstract

Clinical and Laboratory Standards Institute document I/LA34-A—Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs; Approved Guideline provides a framework for the design and validation of a qualitative immunoassay that detects human immunoglobulin E (IgE) antibody to new drugs in various body fluids and tissue extracts. It addresses technical challenges that are uniquely associated with the development of an assay that detects drug-specific IgE antibody in human blood and tissue extracts. It 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 immunoglobulin G antibody assay as part of its quality control program. This guideline is intended for use by clinical and laboratory investigators who are involved in generating preclinical data and performing clinical trials involving new biotherapeutic drugs. It is also intended as a guideline for administrators of manufacturer safety programs, and government regulators who are required to critique IgE antibody assay methods and assess the validity of allergenicity data that have been submitted by innovator pharmaceutical investigators as part of a governmental licensing process for a new drug.