:: Volume 21, Issue 3 (5-2017) ::
ibj 2017, 21(3): 131-141 Back to browse issues page
Main Quality Attributes of Monoclonal Antibodies and Effect of Cell Culture Components
Fatemeh Torkashvand, Behrouz Vaziri *

The culture media optimization is an inevitable part of upstream process development in therapeutic monoclonal antibodies (mAbs) production. The quality by design (QbD) approach defines the assured quality of the final product through the development stage. An important step in QbD is determination of the main quality attributes. During the media optimization, some of the main quality attributes such as glycosylation pattern, charge variants, aggregates, and low-molecular-weight species, could be significantly altered. Here, we provide an overview of how cell culture medium components affects the main quality attributes of the mAbs. Knowing the relationship between the culture media components and the main quality attributes could be successfully utilized for a rational optimization of mammalian cell culture media for industrial mAbs production.

Keywords: Main quality attributes, Monoclonal antibodies, Glycosylation, Fragmentation
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Type of Study: Full Length | Subject: Related Fields

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Volume 21, Issue 3 (5-2017) Back to browse issues page