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Can I read New Frontiers in Cell Line Development: Challenges for Biosimilars on EtoBox?
New Frontiers in Cell Line Development: Challenges for Biosimilars by Jeff Jia Cheng Hou; Joe Codamo; Warren Pilbrough; Benjamin Hughes; Peter P Gray; Trent P Munro is a Engineering article available to read on EtoBox.
What is New Frontiers in Cell Line Development: Challenges for Biosimilars about?
## Abstract Worldwide sales of biologic drugs exceeded US$ 92 billion in 2009. With many biopharmaceutical patents expiring over the next decade, a wave of second‐generation or ‘follow‐on’ biologics will be vying for market share and regulatory approval. Patents cover not only the drugs, but also the molecular modalities that facilitate their high‐level expression. Companies have historically relied on gene amplification to create productive cell lines, yet this lengthy and imprecise process usually leads to extensive variation and unpredictable stability of expression. Biosimilar manufacturers must therefore decide whether traditional methods of cell line development will suffice or if emerging technologies can provide greater reproducibility and speed. Volumetric yields of 1–2 g L^−1^ are adequate for most production processes and the focus has shifted towards reliable and predicable product quality attributes over maximum possible titres. Recent advances in this area include cell lines with targeted genetic modifications, alternative production hosts such as PER.C6® or yeast, and engineered expression vectors, including the UCOE^TM^ and Selexis platforms. Host cell engineering,
Who reads New Frontiers in Cell Line Development: Challenges for Biosimilars?
It is typically read by researchers, students, and practitioners in Engineering.
- Author
- Jeff Jia Cheng Hou; Joe Codamo; Warren Pilbrough; Benjamin Hughes; Peter P Gray; Trent P Munro
- Publisher
- Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 0268-2575)
- Published
- 2011
- Language
- EN
- Field
- Engineering (Physical Sciences)