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Cited by 218

Quality Attributes of Recombinant Therapeutic Proteins: An Assessment of Impact on Safety and Efficacy as Part of a Quality by Design Development Approach

Eon‐Duval, Alex, Broly, Hervé, Gleixner, Ralf·2012·Biotechnology Progress
DOI 10.1002/btpr.1548
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Abstract

Quality by Design (QbD) is a new approach to the development of recombinant therapeutic protein products that promotes a better understanding of the product and its manufacturing process. The first step in the QbD approach consists in identifying the critical quality attributes (CQA), i.e., those quality attributes of the product that have an impact on its clinical efficacy or safety. CQAs are identified through a science‐based risk assessment taking into consideration a combination of clinical and nonclinical data obtained with the molecule or other similar molecules or platform products, as well as the published literature. The purpose of this article is to perform a comprehensive review of the published literature, supporting an assessment of the impact on safety and efficacy of the quality attributes commonly encountered in recombinant therapeutic proteins, more specifically those produced in mammalian cell expression systems. Quality attributes generally observed in biopharmaceutical proteins including product‐related impurities and substances, process‐related impurities, product attributes, and contaminants are evaluated one by one for their impact on biological activity, pharmacokinetics and pharmacodynamics, immunogenicity, and overall safety/toxicity. © 2012 American Institute of Chemical Engineers Biotechnol. Prog., 2012

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Crossref · 10.1002/btpr.1548

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9 of 9 references verified0 citation errors · 0 not checkable

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  • N-linked glycosylation is the most common post-translational modification and impacts the biological activity, pharmacokinetics, and immunogenicity of therapeutic proteins.

    “N‐linked glycosylation is the most common PTM and it impacts the biological activity, pharmacokinetics and immunogenicity of the therapeutic protein [36].”

    From Current PAT Landscape in the Downstream Processing of Biopharmaceuticals (2025) · cites this paper as [36]

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Authors
Eon‐Duval, A., Broly, H., & Gleixner, R.
Venue
Biotechnology Progress
Publisher
Wiley
Published
2012-05
Volume
28
Issue
3
Pages
608-622
ISSN
  • 8756-7938
  • 1520-6033
DOI
10.1002/btpr.1548
Cited by
218
References
9
Language
en
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor, 1 d)

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