Monitoring Effects of Excipients, Formulation Parameters and Mutations on the High Order Structure of Filgrastim by NMR

Author:

Aubin YvesORCID,Hodgson Derek J.,Thach William B.,Gingras Geneviève,Sauvé Simon

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Reference24 articles.

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3. Hill CP, Osslund TD, Eisenberg D. The structure of granulocyte-colony-stimulating factor and its relationship to other growth factors. Proc Natl Acad Sci U S A. 1993;90:5167–71.

4. Arakawa T, Prestrelski SJ, Narhi LO, Boone TC, Kenney WC. Cysteine 17 of recombinant human granulocyte-colony stimulating factor is partially solvent-exposed. J Protein Chem. 1993;12:525–31.

5. EMEA Comparability of biotechnological/biological products subject to changes in their manufacturing process. CPMP/ICH/5721/03, 13 (2006). Canada, H. GUIDANCE FOR SPONSORS: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). 2010/03/05. Health Canada - Publications, 17 (2010). FDA, U. Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product. Office of Communications US FDA UCM291134, 1-20 (2012). FDA, U. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Office of Communications US FDA UCM291128, 1-25 (2012).

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