USP Publishes Monoclonal Antibody Guidelines

Currently, licensed monoclonal antibody (mAb) therapeutics include those involved in the activation of effector cells, cell killing, cross-linked induced apoptosis, antagonism against several targets, and agonist antibodies. Because of structural similarities between antibodies of the same class, th...

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Bibliographic Details
Published in:Pharmaceutical Technology 2015-03, Vol.39 (3), p.24
Main Authors: Schmidt, Dale, Szajek, Anita V, Atouf, Fouad, Morris, Tina
Format: Article
Language:English
Subjects:
Cells
Molecular weight
Monoclonal antibodies
Prescription drugs
Product development
Quality standards
Online Access:Get full text
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Description
Summary:Currently, licensed monoclonal antibody (mAb) therapeutics include those involved in the activation of effector cells, cell killing, cross-linked induced apoptosis, antagonism against several targets, and agonist antibodies. Because of structural similarities between antibodies of the same class, the US Pharmacopeial Convention's (USP) expert panel decided to focus its efforts in developing standards for mAbs on a class of molecules that would be more amenable to a "platform approach" both in terms of manufacturing and analytical development. As individual product monographs will possibly describe specific quality attributes of individual drugs, USP deemed it necessary to have a broad foundation of general standards to set minimum quality requirements for molecule classes, and that is what it hopes to achieve with the publication of the new general chapter.
ISSN:1543-2521
2150-7376