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Review
. 2017 Apr 3;2(1):58-69.
doi: 10.1002/btm2.10061. eCollection 2017 Mar.

Evolving trends in mAb production processes

Abhinav A Shukla  1 , Leslie S Wolfe  1 , Sigma S Mostafa  1 , Carnley Norman  1
Affiliations
Review

Evolving trends in mAb production processes

Abhinav A Shukla et al. Bioeng Transl Med. .

Abstract

Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now routinely achieved for mAbs in mammalian cell culture. These drivers have resulted in significant evolution in process platform approaches. Additionally, several new trends in bioprocessing have arisen in keeping with these needs. These include the consideration of alternative expression systems, continuous biomanufacturing and non-chromatographic separation formats. This paper discusses these drivers in the context of the kinds of changes they are driving in mAb production processes.

Keywords: Fc fusion proteins; biosimilars; bispecific antibodies; continuous bioprocessing; high titer cell culture; monoclonal antibodies; next generation monoclonal antibodies; nonchromatographic separations; platform process; process development.

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Figures

Figure 1
Figure 1
Possible next generation antibody formats
Figure 2
Figure 2
Platform approach to mAb downstream processing at Amgen
Figure 3
Figure 3
Genentech mAb downstream process platform
Figure 4
Figure 4
Platform mAb downstream process at Biogen
Figure 5
Figure 5
Range of factors considered in determining KBI Biopharma's platform approach
Figure 6
Figure 6
KBI Biopharma's approach to mAb downstream processing for FIH manufacturing
Figure 7
Figure 7
Performance of the KBI Biopharma platform DSP approach for several mAbs. (a) HMW clearance, (b) HCP clearance
Figure 8
Figure 8
Principle of continuous chromatography
See this image and copyright information in PMC

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