Robert E. Byrne, Ph.D.

Robert earned his Ph.D. from the Department of Chemistry at the University of Notre Dame in 1980. He continued his academic studies as a Post-Doctoral Research Fellow in Biochemistry and as a Research Associate/Assistant Professor at the University of Chicago.

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He has built an extensive industrial background in R&D and Operations. He has also managed GMP/GLP laboratory operations and has also contributed quality and regulatory consulting services in the medical device, drug, and vaccine industries.

As Eagle’s Vice President of Scientific Affairs, Robert’s diverse experience is a key influence in the implementation of methodologies that improve Eagle’s laboratory operations.

Among various functions, he performs the stability study statistical analysis of data generated by stability-indicating validated test methods. These data are used to support the assignment of beyond-use-dates (BUD) for sterile or non-sterile drug products compounded and stored in the same labeled container-closure systems and appropriately defined storage conditions for the duration of the BUD.

Recently Robert has been focusing more attention on the chemical and microbiological testing needed as controls over equipment cleaning processes following the manufacturing of compounded drugs.

Dr. Byrne is smiling while wearing a white Eagle branded lab coat.


Publications by Dr. Robert Byrne
  1. Bajaj, S.P., Byrne, R., Nowak, T., and Castellino, F.J. (1977) “Interaction of Manganese with Bovine Factor X.” J. Biol. Chem. 252, 4758-4761.
  2. Violand, B.N., Byrne, R., and Castellino, F.J. (1978) “The Effect of α, (ω)-Amino Acids on Human Plasminogen Structure and Activation.” J. Biol. Chem. 253, 5395-5401.
  3. Amphlett, G.W., Byrne, R., and Castellino, F.J. (1978)”The Binding of Metal Ions to Bovine Factor IX.” J. Biol.Chem. 253, 6774-6779.
  4. Byrne, R., and Castellino, F.J. (1978)”The Influence of Metal Ions in the Activation of Bovine Factor IX by the Coagulant Protein of Russell’s Viper Venom.” Arch. Biochem. Biophys. 190, 687-692.
  5. Amphlett, G. W, Byrne, R., and Castellino, F.J. (1979) “The Binding of Calcium to the Activation Products of Bovine Factor IX.” J. Biol. Chem. 254, 6333-6336.
  6. Byrne, R., Amphlett, G.W., and Castellino, F.J. (1980) “Metal Ion Specificity of the Conversion of Bovine Factor IX, IXa, and IXaα to Bovine Factor IXa-β.” J. Biol. Chem. 255, 1430-1435.
  7. Byrne, R., Link, R., and Castellino, F.J. (1980) “A Kinetic Evaluation of Activated Bovine Coagulation Factor IX toward Synthetic Substrates.” J. Biol. Chem. 255, 5336-5341.
  8. Amphlett, G.W., Byrne, R., and Castellino, F.J. (1982) “Cation Binding Properties of the Multiple Subforms of RVV-X, The Coagulant Protein from Vipera Russelli.” Biochemistry 21, 125-132.
  9. Scanu, A.M., Lagocki, P., Edelstein, C., and Byrne, R. (1982) “Apoprotein A-ll and Serum High density lipoprotein (HDL): a Model System for the Study of Protein-Lipid Interactions at a Natural hydrophilic-hydrophobic Interface.” Biophys. J. 37, 179-181.
  10. Blau, L., Bittman, R., Lagocki, P., Byrne, R., and Scanu, A.M. (1982)”Organization of Unesterified cholesterol in High Density Lipoproteins Probed by Filipin.” Biochem. Biophys. Acta 712, 437-443.
  11. Chung, J., Abano, D., Byrne, R., and Scanu, A.M. (1982)”ln Vitro Mass: Activity Distribution of Lecithin-Cholesterol Acyltransferase among Human Plasma Lipoproteins.” Atherosclerosis 45, 33-41.
  12. Byrne, R. and Scanu, A.M. (1983) “Soluble and Immobilized Trypsin as Structural probes of Human High Density Lipoprotein- (3): Enzyme Properties and Kinetics of Proteolysis.” Biochemistry 22, 2894-2903.
  13. Yamamoto, K., Byrne, R.E., Edelstein, C., Shen, B., and Scanu, A.M. (1984) “In Vitro Effect of Triton WR-1339 on Canine Plasma High Density Lipoprotein.” J. Lipid Res. 25, 770-779.
  14. Polacek, D., Byrne, R.E., Burrous, M., and Scanu, A.M. (1984) “Factors Controlling the Release from Human Blood Polymorphonuclear Cells In Vitro of a Proteolytic Activity Directed Against Apolipoprotein A-ll.” J. Biol. Chem. 259, 14531-14536.
  15. Byrne, R.E., Polacek, D., Gordon, J.I., and Scanu, A.M. (1984) “The Enzyme that Cleaves Apolipoprotein A-ll Upon In Vitro Incubation of Human Plasma High Density Lipoprotein-3 with Blood Polymorphonuclear Cells is an Elastase.” J. Biol. Chem. 259, 14537-14543.
  16. Edelstein, C., Byrne, R.E., Yamamoto, K., Zarins, C., and Scanu, A. M. (1985) “Plasma Lipoprotein Changes Attending the Intravenous Administration of Triton WR-1339 in Normolipidemic Dogs: Preferential Effect on High Density Lipoproteins.” J. Lipid Res. 26, 351-359.
  17. Polacek, D., Byrne, R.E., Fless, G.M., and Scanu, A.M., (1986) “In Vitro proteolysis of human plasma low density lipoproteins by an elastase released from human blood polymorphonuclear cells.” J. Biol. Chem. 261, 2057- 2063.
  18. Polacek, D., Byrne, R.E., and Scanu, A. M., (1988) “Modification of low density lipoproteins by polymorphonuclear cell elastase leads to enhanced uptake by human monocyte-derived macrophages via the low density lipoprotein receptor pathway. J. Lipid Res. 29, 797-808.
  19. Byrne, R.E., and Scanu, A. M., (1989) “Apolipoprotein B-100 of plasma low density lipoproteins undergoes proteolysis by contact activation factors when plasma is treated with dextran sulfate- 500/ MgCI2.” J. Lipid Res. 30, 109-120.
  20. Byrne, R.E., Laska, S., Bell, M., Larson, D., Phillips, J. and Todd, J., (1992)”Evaluation of a Treponema pallidum Western Immunoblot Assay as a Confirmatory Test for Syphilis.” J. Clin. Microbiol. 30, 115-122.
  21. Leahy, D., Kink, J., Byrne, R.E., Shah, D., Preisel-Simmons, B., Laska, S., Dienstag, J., Thomas, H., Karayiannis, P., Brown, J., Arima, T., Maeda, E., and Todd, J., (1992) “Improved Serologic Detection of Hepatitis C Virus With a Paramagnetic Microparticle Assay Using Multiple Antigenic Sequences.” Transfusion, 32, No.6: 548-553.
  22. Todd, J., Kink, J., Leahy, D., Preisel-Simmons, B., Laska, S., Wolff, P., Jacobson, P., Byrne, R., Babler, S., McCoy-Haman, M., Shah, D., Schneider, A., Huang, M., Jolley, M., Bethell, D., Kieselburg, M., Saeed, B., and Ryan, T., (1992) ” A Novel Semi-Automated Paramagnetic Microparticle Based Enzyme Immunoassay for Hepatitis C Virus: Its Application to Serologic Testing.” Journal of Immunoassay, 13(3): 393-410.
  23. Ryan, T.E, Saeed, B., Kieselburg, Byrne, R.E., Stevens, P.W., Arima, T., and Todd, J., (1995) “DNA Sequence and Encoded Polypeptide Useful in the Diagnosis of Hepatitis Disease.” U.S Patent Number: 5,437,974.
  24. Maine, G. T., Stricker, R., Schuler, M., Spesard, J., Brojanac, S., Iriarte, B., Herwig, K., Gramins, T., Combs, B., Wise, J., Simmons, H., Gram, T., Lonze, J., Ruzicki, D., Byrne, R., Clifton, J.D., Chovan, L.E., Wachta, D., Holas, C., Wang, D., Wilson, T., Tomazic-Allen, S., Clements, M. A., Wright, G.L., Jr., Lazzarotto, T., Ripalti, A. and Landini, M.P., (2000) “Development and Clinical Evaluation of a Recombinant-Antigen-Based Cytomegalovirus Immunoglobulin M Automated Immunoassay Using the Abbott AxSYM Analyzer” Journal of Clinical Microbiology, 38 (4), 1476-1481.
  25. Jeffrey, M., Koeller, J., Zdunek, J., Byrne, R. and Caputo, R.A., (2004) “Validation of an Enhanced Method of Bacterial Ribotyping for Improved Efficiency and Identification of Stressed Isolates.” Technol. 28 (3), 156-165.
  26. Caputo, R.A., Reich, R., Fisher, J. and Byrne, R., (2005) “Characterization, Properties, and Biological Effects of Vapor Phase Hydrogen Peroxide” Contamination Control, June-July issue, 20-23.
  1. Edelstein, C., Byrne, R., and Scanu, A.M. (1980) “Differences in One-Chain and Two-Chain Apo A-ll on the Surface of High Density Lipoprotein.” Circulation 62, Abs. No.440, p.111.
  2. Byrne, R.E., Edelstein, C., Zarins, C., and Scanu, A.M. (1981) “Distribution of Human (1251) Labeled Apo A-ll Between Plasma and thoracic Duct Lymph in the Dog.” Arteriosclerosis 1, 376a.
  3. Byrne, R.E., and Scanu, A.M. (1986) “Elastase and a1-antitrypsin comigrate with plasma lipoproteins following fractionation in an electric field.” Fed. Proc. 45, Abs. No.1135, p. 1675.
  4. Leahy, D., Kink, J., Preisel-Simmons, B., Byrne R., Shah, D., Zablen, L., Kieselburg, M., Ryan, T., Arima, T., and Todd, J. (1991) ” Immunoreactivity of NANB Hepatitis specimens to an antigenic determinant unrelated to HCV.” Amer. Soc. Microbiol. Annual Meeting Abs. No. V-25, p. 435.
  5. Jeffrey, M., Khorzad, R., Byrne, R., Caputo, R. “Combination of Ribotyping and Genetic Sequencing for Complete Genetic Profiling” American Association of Pharmaceutical Scientists, May 2004.
  6. Kamath, S., Chlebek-Brown, K., Byrne, R. and Caputo, R. “Interim report of the Application of Ribotyping to the Characterization of Yeasts and Moulds”. American Association of Pharmaceutical Scientists, May 2004.
Review Articles
  1. Scanu, A. M., Byrne, R.E., and Mihovilovic, M. (1982) “Functional roles of Plasma High Density Lipoproteins.” Crit. Rev. Biochem. 13, 2, p. 109-140.
  2. Scanu, A. M., Byrne, R.E., and Edelstein, C. (1984) “Proteolytic Events Affecting Plasma Apo-lipoproteins at the Co-and Post-translational Levels and after Maturation.” J. Lipid Res. 25, 1593-1602.
  3. Gordon, J. I., Sims, H.F., Strauss, A. W., Edelstein, C., Byrne, R.E., and Scanu, A. M. (1986) “Proteolytic processing and compartmentalization of the primary translation products of mammalian apolipoprotein mRNAs.” Crit. Rev. Biochem. 20, 37-72.
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