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SELECTED PUBLICATIONS

  1. Mosharraf, M. K.M. G. Taylor and D. Q. M. Craig. Effect of calcium ions on the surface charge and aggregation of Phosphatidyl-choline liposomes, J. Drug Target., 2 (1995) 541-545.

  2.  Mosharraf. M and Nystrom. C. The effect of particle size and shape on the surface specific dissolution rate of microsized, practically insoluble drugs, Int. J. Pharm. 122 (1995) 35-47.
  3.  Mosharraf. M and Nystrm. C. Solubility characterisation of practically insoluble drugs using the Coulter counter principle, Int. J. Pharm. 122 (1995) 57-67.
  4.  Mayer LD, Masin D, Nayar R, Boman NL, Bally MB. “Pharmacology of liposomal vincristine in mice bearing L1210 ascitic and B16/BL6 solid tumours.” Br J Cancer.;71(3):482-8 (1995).
  5.  Mosharraf, M., Sebhatu, T. and Nystrom, C. The effects of disordered structure on the solubility and dissolution rate of sparingly soluble, hydrophilic drugs, Int. J. Pharm, 177 (1999) 29-51.
  6.  Mosharraf, M. and Nystrom, C. The effect of dry mixing on the apparent solubility of sparingly soluble drugs, Eur. J. Pharm. Sci.  9 (1999) 45-156.
  7.  Nayar R and Manning M “High Throughput Formulation: Strategies for Rapid Development of Stable Protein Products” in Pharm Biotechnol. 2002;13:177-98
  8.  Manning M and Nayar R “High Throughput Formulation:  Meeting the Coming Challenge” Biopharm 15 (2): 20-28 (2002).
  9.  Wang W, Antonsen K, Nayar R.  “A novel method for removing residual acetone” Pharm Dev Technol. 2002 May;7(2):169-80.
  10.  Mosharraf, M. and Nystrom, C. The apparent solubility of drugs in partially crystalline systems, J. Drug Dev. Ind. Pharm., 29 (2003) 603-622.
  11. Meyer JD, Jun Bai S, Rani M, Suryanarayanan R, Nayar R, Carpenter JF, Manning MC.  “Infrared spectroscopic studies of protein formulations containing glycine.” J Pharm Sci. 2004 May;93(5):1359-66.
  12.  Mosharraf, M. Assessment of degree of disorder of lyophilized protein formulations by Isothermal Microcalorimetry. J. Drug Dev. Ind. Pharm, 30 (2004) 461-472.
  13. Bai SJ, Rani M, Suryanarayanan R, Carpenter JF, Nayar R, Manning MC. “ Quantification of glycine crystallinity by near-infrared (NIR) spectroscopy.” J Pharm Sci. 2004 Oct;93(10):2439-47.
  14. Bai S, Nayar R, Carpenter JF, Manning MC. “Noninvasive determination of protein conformation in the solid state using near infrared (NIR) spectroscopy.” J Pharm Sci. 2005 Sep;94(9):2030-8.
  15. Katayama DS, Nayar R, Chou DK, Campos J, Cooper J, Vander Velde DG,Villarete L, Liu CP, Cornell Manning M. “ Solution behavior of a novel type 1 interferon, interferon-tau.” J Pharm Sci. 2005 Dec;94(12):2703-15.
  16. Dunn JS, Nayar R, Campos J, Hybertson BM, Zhou Y, Manning MC, Repine JE, Stringer KA. “Feasibility of tissue plasminogen activator formulated for pulmonary delivery.”  Pharm Res. 2005 Oct;22(10):1700-7. Epub 2005 Sep 22
  17. Katayama DS, Nayar R, Chou DK, Valente JJ, Cooper J, Henry CS, Vander Velde DG, Villarete L, Liu CP, Manning MC. “Effect of buffer species on the thermally induced aggregation of interferon-tau.” J Pharm Sci. 2006 Jun;95(6):1212-26.
  18. Payne RW, Nayar R, Tarantino R, Del Terzo S, Moschera J, Di J, Heilman D, Bray B, Manning MC, Henry CS. “Second virial coefficient determination of a therapeutic peptide by self-interaction chromatography.” Biopolymers. 2006;84(5):527-33.
  19. Vessely C, Estey T, Randolph TW, Henderson I, Nayar R, Carpenter JF. “Effects of solution conditions and surface chemistry on the adsorption of three recombinant botulinum neurotoxin antigens to aluminum salt adjuvants.” J Pharm Sci. 2007 Sep;96(9):2375-89.
  20.  Mosharraf, M., Malmberg , M., and Fransson, J.,  Formulation, lyophilization and solid-state properties of a pegylated protein. International Journal of Pharmaceutics, 336 (2007) 215-232.
  21.  Stringer, K.A., Meghan, D., John, S., Campos, J., Van Rheen, Z., Mosharraf, M., and Nayar, R. Accelerated dosing frequency of pulmonary formulation of tissue plasminogen activators is well-tolerated in mice, Clinical and Experimental Pharmacology and Physiology, 35 (2008) 1454-1460.
  22. Roy S, Henderson I, Nayar R, Randolph TW, Carpenter JF. “Effect of pH on stability of recombinant botulinum serotype A vaccine in aqueous solution and during storage of freeze-dried formulations.” J Pharm Sci. 2008 Dec;97(12):5132-46.
  23. Meyer JD, Nayar R, Manning MC.” Impact of bulking agents on the stability of a lyophilized monoclonal antibody.” Eur J Pharm Sci. 2009 Aug 12;38(1):29-38.
  24. Estey T, Vessely C, Randolph TW, Henderson I, Braun LJ, Nayar R, Carpenter JF.”Evaluation of chemical degradation of a trivalent recombinant protein vaccine against botulinum neurotoxin by LysC peptide mapping and MALDI-TOF mass spectrometry. “J Pharm Sci. 2009 Sep;98(9):2994-3012.
  25. Vessely C, Estey T, Randolph TW, Henderson I, Cooper J, Nayar R, Braun LJ, Carpenter JF.” Stability of a trivalent recombinant protein vaccine formulation against botulinum neurotoxin during storage in aqueous solution.” J Pharm Sci. 2009 Sep;98(9):2970-93.
  26. Lackowski NP, Pitzer JE, Tobias M, Van Rheen Z, Nayar R, Mosharaff M, Stringer KA, “Safety of prolonged, repeated administration of a pulmonary formulation of tissue plasminogen activator in mice.” Pulm Pharmacol Ther. 2010 Apr;23(2):107-14.
  27.  Nayar, R., and Mosharraf, M., Formulation Development of Biopharmaceuticals , Pharmaceutical Formulation & Quality, September 2010.

BOOK/ BOOK CHAPTER

  1.  Nayar, R., Manning, M.C., "High throughput formulation: strategies for rapid development of stable protein products" in Rational Design of Stable Protein Formulations, Theory and Practice., Edt by Carpenter, J. and Manning, M., 2002, Pharmaceutical biotechnology, Vol 13, Kluwer Academic/ Plenum Publishers, New York, pp. 177-198.
  2. Nayar, R., Schroit, A.J., Fidler, I.J., "Liposome encapsulation of muramyl peptides for activation of macrophage cytotoxic properties" in Methods in Enzymology, Vol. 132,1986 , pp. 594-603.
  3. Mosharraf, M., The Effects of Solid State Properties on Solubility and In Vitro Dissolution Behaviour of Suspended Sparingly Soluble Drugs. Acta Universitatis Upsaliensis, Reprocentralen, Uppsala, 1999, IBSN 91-554-4474-1. (This book can be obtained from HTD Biosystems upon request).
  4. Effective Approaches to  Formulation Development of  Biopharmaceuticals, in "Formulation And  Process Development Strategies For Manufacturing Biopharmaceuticals", Edited by F. Jamal and S. Hershenson. John Wiley & sons, INC., US, 2010 , pp. 309-328  (ISBN 978-0-470-11812-2).