Chapter 2 : Fc glycans of therapeutic antibodies as critical quality attributes ( CQAs )
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Fc glycans of therapeutic antibodies as critical quality attributes
Critical quality attributes (CQA) are physical, chemical, biological or microbiological properties or characteristics that must be within an appropriate limit, range or distribution to ensure the desired product quality, safety and efficacy. For monoclonal antibody therapeutics that rely on fraction crystalizable (Fc)-mediated effector function for their clinical activity, the terminal sugars o...
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Introduction Monoclonal antibodies (mAbs) are currently the highestselling products of the biopharmaceutical industry, having had global sales of over $45 billion in 2012 [1]. All commercially-available mAbs contain a consensus N-linked glycosylation site on each of the Cg2 domains of their constant fragment (Fc). The monosaccharide composition and distribution of these N-linked carbohydrates (...
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Understanding process parameter interactions and their effects on mammalian cell cultivations is an essential requirement for robust process scale-up. Furthermore, knowledge of the relationship between the process parameters and the product critical quality attributes (CQAs) is necessary to satisfy quality by design guidelines. So far, mainly the effect of single parameters on CQAs was investig...
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Characterization of biopharmaceutical proteins and assessment and understanding of the critical quality attributes (CQAs) is a significant part of biopharmaceutical product development and is routinely performed in vitro. In contrast, systematic analysis of the quality attributes in vivo is not as widespread, although metabolism and clearance of multiple variants of therapeutic proteins adminis...
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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 attribute...
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