High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies - An approach to biopharmaceutical development that combines Quality by Design with a suite of visual

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High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
An approach to biopharmaceutical development that combines Quality by Design with a suite of visual informatics tools to reduce scale-up risks.


BioPharm International


CONCLUSIONS

This article outlines a QbD-based strategy for maintaining comparability of glycosylation during biopharmaceutical scale-up. It also describes visual informatics tools that aid the implementation of QbD and simplify the analysis of complex information on drug glycosylation. This strategy is not suitable for all drug developers—it requires a serious consideration of glycosylation early on in biopharmaceutical development, an adoption of new models for drug realization, and the consequent commitment of scientific resources. However, the reward should be a therapy that has better clinical performance, is readily scalable, and that can be brought to market in a timely way.

ACKNOWLEDGEMENTS

I thank the following for interesting discussions on QbD, the A-MAb project, and drug glycosylation: Ron Taticek, PhD, Lynne Krummen, PhD, and Paul Motchnik, PhD, of Genentech, and Michael DeFelippis, PhD, and Bruce Meiklejohn, PhD, of Eli Lilly.

Daryl Fernandes is the chief executive officer of Ludger Ltd., Cuham Science Centre, Oxfordshire, UK, +44 1865 408 554,

REFERENCES

1. Fernandes, DL. A QbD approach to biopharmaceutical glycosylation. In: Lyscom N, editor. Quality for biologics—critical quality attributes, process and change control, product variation, characterisation, and regulatory concerns. Hampshire, UK: Biopharm Knowledge Publishing; 2008 Dec.

2. International Society for Pharmaceutical Engineering. CMC Biotech Working Group. A-Mab: A case study in bioprocess development. An e-publication; 2009. Available from: http://www.ispe.org/.

3. European Commission. EMEA guideline on development, production, characterisation and specifications for monoclonal antibodies and related products EMEA/CHMP/BWP/157653/2007. London, UK: 2008 Dec.

4. Domann PJ, Pardos-Pardos AC, Fernandes DL, Spencer DI, Radcliffe CM, Royle L, Dwek RA, Rudd PM. Separation-based glycoprofiling approaches using fluorescent labels. Proteomics. 2007;Suppl 1:70–76.

5. Fernandes DL, Spencer, DI. Glycoprotein analysis. In: Fraser-Reid BO, Tatsuta K, Thiem J, editors. Glycoscience—chemistry and chemical biology. New York, NY: Springer Berlin Heidelberg; 2008.

6. Van Berkel PH, Gerritsen J, Perdok G, Valbjørn J, Vink T, van de Winkel JG, Parren PW. N-linked glycosylation is an important parameter for optimal selection of cell lines producing biopharmaceutical human IgG. Biotechnol Prog. 2009;25:244–51.

7. Legmann R, Schreyer HB, Combs RG, McCormick EL, Russo AP, Rodgers ST. A predictive high-throughput scale-down model of monoclonal antibody production in CHO cells. Biotechnol Bioeng. 2009 Dec 15;104(6):1107–20.

8. Butler M. Animal cell cultures: Recent achievements and perspectives in the production of biopharmaceuticals. Appl Microbiol Biotechnol 2005;68:283–91.

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