| Author | Title | Year | Company (Country) | Reftype | Comments |
|---|---|---|---|---|---|
| Cinkaya, I. | The impact of disposables on the manufacturing of biosimilars [Abstract] |
2010 | Merckle Biotec GmbH (Germany) | standard | |
| Abstract:The approval of the first recombinant Insulin in 1982 was the starting point for the success story of the biopharmaceutical industry. Followed by other biopharmaceuticals like Somatotropin (rhGH), Erythropoetin (EPO) or Granulocyte colony-stimulating factor (G-CSF) the eighties mark the age of hormone substitution products. After three decades of this innovative time period this class of products have demonstrated their right to exist and are still on the market. However, the health care authorities are facing high treatment expenses, which limits the use of this products to a broader population. Meanwhile the patents expired or going to be expire in the next years. This gives other companies the opportunity to launch biosimilars, from the regulatory point of view products with comparable safety and efficiency to a reference originator product. This new emerging field of biosimilars provide the opportunity to develop manufacturing processes and facility designs considering disposable technologies. Disposables may posses a valuable alternative to classical stainless steel approaches, which was missing some decades before. An overview on the biosimilar business, the manufacturing strategies including monoclonal antibody production and an excerpt of the case-study Merckle Biotec will be given. | |||||
BibTeX:
@standard{Cinkaya2010,
author = {Irfan Cinkaya},
title = {The impact of disposables on the manufacturing of biosimilars},
journal = {Merckle Biotec GmbH (Germany)},
year = {2010}
}
|
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Created by JabRef on 23/03/2010.