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Immunogenicity of therapeutic proteins. Part 1: Impact of product handling

Paper ID Volume ID Publish Year Pages File Format Full-Text
14839 1258 2007 8 PDF Available
Title
Immunogenicity of therapeutic proteins. Part 1: Impact of product handling
Abstract

The patents of first-generation biopharmaceutical proteins are expiring, creating opportunities for biosimilar products. Unlike conventional generic pharmaceuticals, the development of biosimilar products is far more complex and requires more than a simple demonstration of pharmacological bioequivalence to establish efficacy and safety. The main concern with biosimilar products, as for any therapeutic protein, is immunogenicity and with it the potential for serious clinical sequelae. In the absence of adequate predictors of immunogenicity outside the clinical trial setting, biosimilar products should be evaluated in the same way that any novel pharmaceutical is evaluated. Herein, the factors involved in breaking host tolerance following administration of a therapeutic protein are discussed. The impact of product handling on immunogenicity is considered in the context of some hard-fought lessons that have helped to shape the current era of biopharmaceutical manufacturing, packaging, distribution, storage, and quality assurance.

Keywords
Biopharmaceutical; Therapeutic protein; Biosimilar; Immunogenicity; Neutralizing antibody; Epoetin; PRCA
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Publisher
Database: Elsevier - ScienceDirect
Journal: Biotechnology Advances - Volume 25, Issue 3, May–June 2007, Pages 310–317
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us