Establishing analytical comparability for "biosimilars": Filgrastim as a case study

Analytical and Bioanalytical Chemistry

Volumn 406, Issue 26, 2014, Pages 6569-6576

  Rathore, Anurag S ^a   Bhambure, Rahul ^a  

^a INDIAN INSTITUTE OF TECHNOLOGY DELHI   (India)

Author keywords

Analytical comparability; Biopharmaceuticals; Biosimilars; Filgrastim; Granulocyte colony stimulating factor (GCSF)

Indexed keywords

ESCHERICHIA COLI;

ANALYTICAL COMPARABILITY; BIOPHARMACEUTICALS; BIOSIMILARS; FILGRASTIM; GRANULOCYTE-COLONY STIMULATING FACTOR;

PROTEINS;

ESCHERICHIA COLI;

BIOSIMILAR AGENT; FILGRASTIM; GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT PROTEIN;

AMINO ACID SEQUENCE; CHEMISTRY; CIRCULAR DICHROISM; COMPARATIVE STUDY; ESCHERICHIA COLI; GENE EXPRESSION; GENETICS; MASS SPECTROMETRY; METABOLISM; MOLECULAR GENETICS; POLYACRYLAMIDE GEL ELECTROPHORESIS; PROTEIN CONFORMATION; REVERSED PHASE LIQUID CHROMATOGRAPHY;

AMINO ACID SEQUENCE; BIOSIMILAR PHARMACEUTICALS; CHROMATOGRAPHY, REVERSE-PHASE; CIRCULAR DICHROISM; ELECTROPHORESIS, POLYACRYLAMIDE GEL; ESCHERICHIA COLI; GENE EXPRESSION; GRANULOCYTE COLONY-STIMULATING FACTOR; MASS SPECTROMETRY; MOLECULAR SEQUENCE DATA; PROTEIN CONFORMATION; RECOMBINANT PROTEINS;

EID: 84928376312     PISSN: 16182642     EISSN: 16182650     Source Type: Journal    
DOI: 10.1007/s00216-014-7887-4     Document Type: Article

References (34)

1. Schellekens H (2004) Nat Biotechnol 22:1357-1359
2. Belsey MJ, Harris LM, Das RR, Chertkow J (2006) Nat Rev Drug Discov 5:535-536
3. Walsh G (2005) Trends Biotechnol 23:553-558
4. Rathore AS (2009) Trends Biotechnol 27:698-705
5. Weise M, Bielsky M-C, Smet KD, Ehmann F, Ekman N, Narayanan G, Heim H-K, Heinonen E, Ho K, Thorpe R, Vlemickx C, Wadhwa M, Schneider CK (2011) Nat Biotechnol 29:690-693
6. Berkowitz SA, Engen JR, Mazzeo JR, Jones GB (2012) Nat Rev Drug Discov 11:527-540
7. Chirino AJ, Mire-Sluis A (2004) Nat Biotechnol 22:1383-1389
8. Schneider CK, Kalinke U (2008) Nat Biotechnol 26:985-990
9. Kresse GB (2009) Eur J Pharm Biopharm 72:479-486
10. Skrlin A, Radic I, Vuletic M, Schwinke D, Runac D, Kusalic T, Paskvan I, Krsic M, Bratos M, Marinc S (2010) Biologicals 38:557-566
11. Ashton G (2001) Nat Biotechnol 19:307-311
12. Rathore AS, Low D (2010) BioPharm Int 23(11):34-40
13. Hagel L, Jagschies G, Sofer G (2007) Handbook of process chromatography, 2nd edn. Academic, New York
14. International Conference on Harmonisation Guideline Q8 (R1) (2008) Pharmaceutical Development. Geneva, Switzerland: International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.
15. US Food and Drug Administration. FDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products FDA, Rockville, MD, April 1996. http://www.fda.gov/cder/Guidance/compare.htm
16. US Food and Drug Administration. Revised guidance for industry: providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format - biologics marketing applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)] FDA, Rockville, MD, November 1999. http://www.cfsan.fda.gov/-dms/opaegui3.html
17. Petit I, Szyper-Karavitz M, Nagler A, Lahav M, Peled A, Habler L, Ponomaryov T, Taichman RS, Arenzana-Seisdedos F, Fujii N, Sandbank J, Zipori D, Lapidot T (2002) Nat Immunol 3:687-694
18. Aritomi M, Kunishima N, Okamoto T, Kuroki R, Ota Y, Morikawa K (1999) Nature 401:713-717
19. Chu JW, Yin J, Wang DI, Trout BL (2004) Biochemistry 43:1019-1029
20. Chu JW, Brooks BR, Trout BL (2004) J Am Chem Soc 126:16601-16607
21. Lu HS, Fausset PR, Sotos LS, Clogston CL, Rohde MF, Stoney KS, Herman AC (1993) Protein Expr Purif 4:465-472
22. Guillon JM, Mechulam Y, Schmitter JM, Blanquet S, Fayat G (1992) J Bacteriol 174:4294
23. Schenauer MR, Flynn GC, Goetze AM (2012) Anal Biochem 428:150-157
24. Wang X, Junter AK, Mozier NM (2009) Biotechnol Bioeng 103:446-458
25. Valente KN, Schaefer AK, Kempton HR, Lenhoff AM, Lee KH (2014) Biotechnol J 9:87-99
26. Xie H, Chakraborty A, Ahn J, Yu YQ, Dakshinamoorthy DP, Chen W, Skilton J, Mazzeo J (2010) mAbs 2:379-394
27. Doneanu CE, Xenopoulos A, Fadgen K, Murphy J, Skilton SJ, Prentice H, Stapels M, Chen W (2012) mAbs 41:24-44
28. Gilar M, Xie H, Chakraborty A, Ahn J, Yu YQ, Chen W, Skilton J, Mazzeo J, Dakshinamoorthy DP (2010) Biopharm Int 2010:1-4
29. Bhambure R, Gupta D, Rathore AS (2013) J Chromatogr A 1314:188-198
30. Bhambure R, Sharma R, Gupta D, Rathore AS (2013) J Chromatogr A 1307:49-57
31. Bade P, Kotu SP, Rathore AS (2012) J Sep Sci 35:3160-3169
32. Filgrastim concentrated solution: European Pharmacopoeia Monograph 7:2015-2018
33. Cygnus application notes. http://cygnustechnologies.com/product-detail/bacterial/e-coli-hcp-elisa-kit.html
34. Invitrogen application notes. http://www.invitrogen.com/site/us/en/home/brands/Product-Brand/Quant-iT.html