Biophysical characterization of a protein for structure comparison: methods for identifying insulin structural changes

Author:

Sklepari M.1234,Rodger A.1234ORCID,Reason A.5674,Jamshidi S.1234,Prokes I.1234,Blindauer C. A.1234

Affiliation:

1. Department of Chemistry

2. University of Warwick

3. Coventry CV4 7AL

4. UK

5. Biopharmaspec Ltd

6. Lido Medical Centre

7. Jersey JE2 7LA

Abstract

Combination of four well-established techniques complemented with temperature dependence for probing structural changes and detecting differences between insulin samples.

Funder

Research Executive Agency

Publisher

Royal Society of Chemistry (RSC)

Subject

General Engineering,General Chemical Engineering,Analytical Chemistry

Reference83 articles.

1. L. K. Altman, A new insulin given approval for use in U.S., http://www.nytimes.com/1982/10/30/us/a-new-insulin-given-approval-for-use-in-us.html, accessed 3rd May 2016

2. U.S. Food and Drug Administration, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf, accessed 11 Nov, 2015

3. European Medicines Agency, Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184161.pdf, accessed 26 Oct, 2015

4. European Medicines Agency, Note for guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products (CPMP/ICH/365/96) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002824.pdf, accessed 28 Oct, 2015

5. More than insulin

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