Cited by 294Protein purification and stabilityBiosimilars and Bioanalytical MethodsMonoclonal and Polyclonal Antibodies Research

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Determination of critical quality attributes for monoclonal antibodies using quality by design principles

Alt, Nadja, Zhang, Taylor Y., Motchnik, Paul, Taticek, Ron, Quarmby, Valerie, Schlothauer, Tilman, Beck, Hermann, Emrich, Thomas, Harris, Reed J.·2016·Biologicals

DOI 10.1016/j.biologicals.2016.06.005

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Abstract

Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11). An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes the identification of critical quality attributes (CQAs) as an important first step for QbD development of biopharmaceuticals. A systematic scientific based risk ranking and filtering approach allows a thorough understanding of quality attributes and an assignment of criticality for their impact on drug safety and efficacy. To illustrate the application of the approach and tools, a few examples from monoclonal antibodies are shown. The identification of CQAs is a continuous process and will further drive the structure and function characterization of therapeutic proteins.

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Authors: Alt, N., Zhang, T. Y., Motchnik, P., Taticek, R., Quarmby, V., Schlothauer, T., Beck, H., Emrich, T., & Harris, R. J.
Affiliations: Genentech (US)
F. Hoffmann-La Roche AG (CH)
Corresponding author: Alt, Nadja
ORCID: Quarmby, Valerie
Schlothauer, Tilman
Emrich, Thomas
Venue: Biologicals
Publisher: Elsevier BV
Published: 2016-09
Volume: 44
Issue: 5
Pages: 291-305
ISSN: 1045-1056 (ISSN-L)
DOI: 10.1016/j.biologicals.2016.06.005
OpenAlex: W2498896723
Cited by: 294
References: 54
Citations by year: 2026: 27 · 2025: 31 · 2024: 39 · 2023: 31 · 2022: 39 · 2021: 29 · 2020: 35 · 2019: 18 · 2018: 18 · 2017: 19 · 2016: 7
FWCI: 1.87
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Biologicals (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
Keywords: critical quality attributes, quality by design, monoclonal antibodies, biopharmaceuticals, risk assessment, risk prioritization, recombinant protein expression, drug safety and efficacy, process knowledge
MeSH terms: Animals, Antibodies, Monoclonal, Humans, Quality Control, Recombinant Proteins

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Determination of critical quality attributes for monoclonal antibodies using quality by design principles

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