Economic aspects of commercial manufacture of biopharmaceuticals

Journal of Biotechnology
Rolf G Werner

Abstract

Sustained approvals of new biopharmaceuticals supported by a sparkling pipeline are the drivers for the above-market growth of biopharmaceuticals. Due to usually high therapeutic dose of monoclonal antibodies, they are demanding for high capacity needs. This requires significant capital investment and stimulates innovation for process improvement to decrease cost of goods and to save capital investments. Such process improvements are either ongoing along the learning curve or result from significant process changes through regulatory authorities impact. Both approaches require extensive protein analytical guidance to maintain product quality, safety and equivalency. In addition to second generation processes, second generation products have the feature of optimizing the physiological principle of biopharmaceuticals to the therapeutic need and to decrease the therapeutic dose, which goes along with investment savings and lower cost of goods.

References

Jan 14, 2004·Breast Cancer : the Journal of the Japanese Breast Cancer Society·Masakazu ToiShigehira Saji
Jan 22, 2004·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Régis Sodoyer
Jul 5, 2005·Expert Opinion on Investigational Drugs·R G Werner

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Citations

Nov 23, 2006·Biotechnology Letters·Brigitte Gasser, Diethard Mattanovich
Sep 22, 2007·Biotechnology Letters·Martin Schröder
Nov 13, 2008·Cytotechnology·Joanne KeenanMartin Clynes
Nov 13, 2008·Cytotechnology·Saeed U Khan, Martin Schröder
Jan 5, 2011·Cytotechnology·Yoshinobu KonnoShinji Hosoi
Sep 13, 2013·Cytotechnology·Ahmad M HaredyTakeshi Omasa
Dec 29, 2009·Médecine sciences : M/S·Olivier Cochet, Michel Chartrain
Feb 14, 2012·Proceedings of the National Academy of Sciences of the United States of America·Sang-Chul LeeHak-Sung Kim
Sep 4, 2007·Applied and Environmental Microbiology·Brigitte GasserDiethard Mattanovich
Jan 3, 2014·Journal of Controlled Release : Official Journal of the Controlled Release Society·Mark T OrrThomas S Vedvick
Jun 11, 2011·BMC Biotechnology·Tiina A RiihimäkiVesa P Hytönen
Nov 22, 2005·Expert Opinion on Drug Delivery·Marco van de WeertSven Frokjaer
Sep 28, 2015·Applied Biochemistry and Biotechnology·Nitu MaityVikram Sahai
Jul 4, 2009·Trends in Biotechnology·Bangaru BalasundaramDaniel G Bracewell
Apr 16, 2009·Protein Expression and Purification·Julita K GrzeskowiakAlois Jungbauer
Jan 24, 2009·Journal of Biotechnology·Thomas I PotgieterMarc d'Anjou
Jul 24, 2007·Current Opinion in Biotechnology·Arne Skerra
Nov 3, 2006·Molecular Immunology·Greg A LazarPhilip W Hammond
May 20, 2009·Biotechnology Journal·Patrick Francis, Charles A Haynes
Mar 30, 2007·Acta Paediatrica. Supplement·Rolf G WernerMichael Schlueter
Mar 19, 2011·Biotechnology Journal·Jarka GlasseyCarl-Fredrik Mandenius
Dec 20, 2011·Biotechnology and Bioengineering·Zihe LiuJens Nielsen
Mar 6, 2010·Biotechnology Progress·Christopher J DetzelCornelius F Ivory
Aug 2, 2005·Trends in Biotechnology·Thomas HeyMarkus Fiedler
May 28, 2015·Journal of Biotechnology·Jason WaltherKonstantin Konstantinov
Dec 7, 2013·Journal of Receptor and Signal Transduction Research·Weiyan CaiTai Kubo
Jan 10, 2018·Proceedings of the National Academy of Sciences of the United States of America·Chiu-Ping LiuChi-Huey Wong
Aug 26, 2006·Biotechnology and Bioengineering·John E BurkyPaul W Sauer
Feb 24, 2009·Annals of Medicine·Haritha SamaranayakeSeppo Ylä-Herttuala
Jun 19, 2019·Biotechnology and Bioengineering·Pere Mir-ArtiguesTeresa Capell

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