Abstract
By combining the current biological and engineering achievements in mAb upstream- and down-stream processing into a “realistic” large scale manufacturing set-up, COG below EUR 20 per g bulk drug substance can be met. This rely on 10 g/L expression level, efficient harvesting by centrifugation and two step chromatography process utilizing either Protein A or in specific cases cat-ion exchange chromatography capture with a second mixed-mode polishing step, combined with the necessary virus inactivation virus removal and ultra filtration steps.
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Acknowledgements
There authors are grateful to following persons suggestions, data and advice, Dr Suzanne S Farid, UCL (UK), Paul Liu, Pall Life Sciences (US), Mr Aulis Rajala, Elomatic Oy (Finland), Mr Thorsten Kimmel, Pharmadule (Sweden) and Jan Berglof, Bio-Works (Hong Kong).
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Hammarberg, B., Forsberg, B. (2010). Affordable Mab by Ensuring Low Cog. In: Kamihira, M., Katakura, Y., Ito, A. (eds) Animal Cell Technology: Basic & Applied Aspects. Animal Cell Technology: Basic & Applied Aspects, vol 16. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-3892-0_6
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DOI: https://doi.org/10.1007/978-90-481-3892-0_6
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