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Ramezani V, Vatanara A, Najafabadi AR, et al. A comparative study on the physicochemical and biological stability of IgG1 and monoclonal antibodies during spray drying process. Daru. 2014;22(1):31doi: 10.1186/2008-2231-22-31.
Ramezani, V., Vatanara, A., Najafabadi, A. R., Shokrgozar, M. A., Khabiri, A., & Seyedabadi, M. (2014). A comparative study on the physicochemical and biological stability of IgG1 and monoclonal antibodies during spray drying process. Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 22(1), 31. https://doi.org/10.1186/2008-2231-22-31
Ramezani, Vahid, et al. "A comparative study on the physicochemical and biological stability of IgG1 and monoclonal antibodies during spray drying process." Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences vol. 22,1 (2014): 31. doi: https://doi.org/10.1186/2008-2231-22-31
Ramezani V, Vatanara A, Najafabadi AR, Shokrgozar MA, Khabiri A, Seyedabadi M. A comparative study on the physicochemical and biological stability of IgG1 and monoclonal antibodies during spray drying process. Daru. 2014 Mar 18;22(1):31. doi: 10.1186/2008-2231-22-31. PMID: 24641877; PMCID: PMC3972992.
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Daru. 2014 Mar 18;22(1):31. doi: 10.1186/2008-2231-22-31.

A comparative study on the physicochemical and biological stability of IgG1 and monoclonal antibodies during spray drying process.

Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences

Vahid Ramezani, Alireza Vatanara, Abdolhossein Rouholamini Najafabadi, Mohammad Ali Shokrgozar, Alireza Khabiri, Mohammad Seyedabadi

Affiliations

  1. Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. [email protected].

PMID: 24641877 PMCID: PMC3972992 DOI: 10.1186/2008-2231-22-31

Abstract

BACKGROUND: The main concern in formulation of antibodies is the intrinsic instability of these labile compounds. To evaluate the physicochemical stability of antibody in dry powder formulations, physical stability of IgG1 and a monoclonal antibody (trastuzumab) during the spray drying process was studied in a parallel study and the efficacy of some sugar based excipients in protection of antibodies was studied.

RESULTS: The SDS-PAGE analysis showed no fragmentation of antibodies after spray drying in all formulations. The secondary structure of antibodies contained 40.13 to 70.19% of β structure in dry state. Also, CD spectroscopy showed the similar secondary structure for trastuzumab after reconstitution in water. ELISA analysis and cell culture studies were conducted in order to evaluate bioactivity of monoclonal antibody. Formulations containing combination of excipients provided maximum tendency of trastuzumab to attach to the ELISA antigen (86.46% ± 2.3) and maximum bioactivity when incubated with SKBr3 cell line (the cell viability was decreased to 65.99% ± 4.6). Incubation of formulations with L929 cell line proved the biocompatibility of the excipients and non-toxic composition of formulations.

CONCLUSION: The IgG1 and trastuzumab demonstrated similar behavior in spray drying process. The combination of excipients containing trahalose, hydroxypropyl beta cyclodextrin and beta cyclodextrin with proper ratio improved the physical and chemical stability of both IgG1 and monoclonal antibody.

References

  1. J Control Release. 2009 Apr 17;135(2):127-35 - PubMed
  2. J Pharm Sci. 2007 Jan;96(1):1-26 - PubMed
  3. Eur J Pharm Sci. 2010 Jul 11;40(4):376-80 - PubMed
  4. Int J Pharm. 2009 Feb 23;368(1-2):109-15 - PubMed
  5. J Pharm Sci. 2009 Sep;98(9):2886-908 - PubMed
  6. Adv Drug Deliv Rev. 2006 Aug 7;58(5-6):686-706 - PubMed
  7. Protein Cell. 2010 Apr;1(4):319-330 - PubMed
  8. Arch Biochem Biophys. 1993 Jun;303(2):465-73 - PubMed
  9. N Engl J Med. 2005 Oct 20;353(16):1734-6 - PubMed
  10. J Reprod Immunol. 2002 Jul-Aug;56(1-2):61-76 - PubMed
  11. Acta Pharm Hung. 2007;77(2):150-4 - PubMed
  12. Clin Pharmacokinet. 1997 Apr;32(4):313-23 - PubMed
  13. Expert Opin Pharmacother. 2004 Jan;5(1):81-96 - PubMed
  14. Biophys J. 1993 Aug;65(2):661-71 - PubMed
  15. J Pharm Sci. 1998 Nov;87(11):1406-11 - PubMed
  16. Eur J Pharm Biopharm. 2005 Feb;59(2):251-61 - PubMed
  17. Am J Respir Cell Mol Biol. 2012 Nov;47(5):709-17 - PubMed
  18. Eur J Pharm Biopharm. 2008 Aug;69(3):793-807 - PubMed
  19. Pharm Biotechnol. 1996;9:1-140 - PubMed

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