Enhanced expression of a biosimilar monoclonal antibody with a novel NS0 platform
Author:
Affiliation:
1. BioFactura, Inc., 8435 Progress Drive, Suite Z; Frederick MD 21701
2. Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), University of Maryland, College Park; MD 20742
Publisher
Wiley
Subject
Biotechnology
Reference41 articles.
1. European Medicines Agency 2009
2. Expression of correctly folded proteins in Escherichia coli;Georgiou;Curr Opin Biotech.,1996
3. Biosimilars: Impact of biologic product life cycle and European experience on the regulatory trajectory in the United States;Ahmed;Clin Ther.,2012
4. Informed by the European Union experience: What the United States can anticipate and learn from the European Union's regulatory approach to biosimilars;Gitter;Seton Hall Law Rev.,2011
5. European Medicines Agency 2006
Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
1. Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI‐751): Results From a Randomized Phase 1 Trial;Clinical Pharmacology in Drug Development;2023-07-22
2. Recombinant Antibody Production in CHO and NS0 Cells: Differences and Similarities;BioDrugs;2018-11-30
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