Details

Autor(en) / Beteiligte

• Torkashvand, Fatemeh
• Vaziri, Behrouz

Titel

Main Quality Attributes of Monoclonal Antibodies and Effect of Cell Culture Components

Ist Teil von

• Iranian biomedical journal, 2017-05, Vol.21 (3), p.131-141

Ort / Verlag

Iran: Pasteur Institute of Iran

Erscheinungsjahr

2017

Link zum Volltext

Quelle

Elektronische Zeitschriftenbibliothek (Open access)

Beschreibungen/Notizen

• 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.