Publications

1.   Orr, J.D. and Reid, G.L. (2020): Analytical Methods in the Clinical Phase of Development. In: Riley, C.M., Rosanske, T.W., and Reid, G.L. (Eds), Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, Elsevier, pp. 101-124. 

2.   Orr, J.D. and Reid, G.L. Process Analytical Technology: Meeting FDA’s Aspirational Guidance in Continuous Manufacturing. Pharmaceutical Online, Guest Column, July 9, 2018. https://www.pharmaceuticalonline.com/doc/process-analytical-technology-meeting-fda-s-aspirational-guidance-in-continuous-manufacturing-0001. 

3.   Orr, J.D. and Reid, G.L. Process Analytical Technology: Benefits of Spectroscopic Tool Use. Pharmaceutical Online, Guest Column, December 1, 2017. https://www.pharmaceuticalonline.com/doc/process-analytical-technology-benefits-of-spectroscopic-tool-use-0001. 

4.   Orr, J.D. and Reid, G.L. An Introduction to Process Analytical Technology. Pharmaceutical Online, Guest Column, June 21, 2017. https://www.pharmaceuticalonline.com/doc/an-introduction-to-process-analytical-technology-0001. 

5.   Chase, C.E., Choi, H.-W., Endo, A., Fang, F.G., and Orr, J.D. (2015): Development and Commercialization of a Fully Synthetic Marine Natural Product, Halaven (Eribulin Mesylate). In: Baker, B.J. (Ed.), Marine Biomedicine: From Beach to Bedside, CRC Press, Taylor & Francis Group, pp. 497-529. 

6.   Faul, M.M., Argentine, M.D., Egan, M., Eriksson, M.C., Ge, Z., Hicks, F., Kiesman, W.F., Mergelsberg, I., Orr, J.D., Smulkowski, M., and Wachter, G.A. Part 3: Designation and Justification of API Starting Materials: Proposed Framework for Alignment from an Industry Perspective. Organic Process Research & Development, 2015, 19 (8), 915-924. DOI: 10.1021/acs.oprd.5b00079. 

7.   Faul, M.M., Busacca, C.A., Eriksson, M.C., Hicks, F., Kiesman, W.F., Smulkowski, M., Orr, J.D., and Pfeiffer, S. Part 2: Designation and Justification of API Starting Materials: Current Practices across Member Companies of the IQ Consortium. Organic Process Research & Development, 2014, 18 (5), 594-600. DOI: 10.1021/op5000607. 

8.   Faul, M.M., Kiesman, W.F., Smulkowski, M., Pfeiffer, S., Busacca, C.A., Eriksson, M.C., Hicks, F., and Orr, J.D. Part 1: A Review and Perspective of the Regulatory Guidance to Support Designation and Justification of API Starting Material. Organic Process Research & Development 2014, 18 (5), 587-593. DOI: 10.1021/op500059k. 

9.   Bordawekar, S., Chanda, A., Daly, A.M., Garrett, A.W., Higgins, J.P., LaPack, M.A., Maloney, T.D., Morgado, J., Mukherjee, S., Orr, J.D., Reid, G.L., Yang, B., and Ward, H.W. Industry Perspectives on Process Analytical Technology: Tools and Applications in API Manufacturing. Organic Process Research & Development, 2015, 19 (9), 1174-1185. DOI: 10.1021/acs.oprd.5b00088. 

10. Chanda, A., Daly, A.M., Foley, D.A., LaPack, M.A., Mukherjee, S., Orr, J.D., Reid, G.L. III, Thompson, D.R., and Ward, H.W. II. Industry Perspectives on Process Analytical Technology: Tools and Applications in API Development. Organic Process Research & Development, Article ASAP, 2014: DOI: 10.1021/op400358b. 

11. Austad, B.C., Calkins, T.L., Chase, C.E., Fang, F.G., Horstmann, T.E., Hu, Y., Lewis, B.M., Niu, X., Noland, T.A., Orr, J.D., Schnaderbeck, M.J., Zhang, M., Asakawa, N., Asai, N., Chiba, H., Hasebe, T., Hoshino, Y., Ishizuka, H., Kajima, T., Kayano, A., Komatsu, Y., Kubota, M., Kuroda, H., Miyazawa, M., Tagami, K., and Watanabe, T. Commercial Manufacture of Halaven®: Chemoselective Transformations En Route to Structurally Complex Macrocyclic Ketones. Synlett, 2013; 24(3): 333-337. DOI: 10.1055/s-0032-1318026. 

12. Orr, J.D., Swartz, M.E., and Krull, I.S. Validation of impurity methods. Part 2, LC/GC Magazine, 21(12), 1146 (2003). 

13. Orr, J.D., Krull, I.S., and Swartz, M.E. Validation of impurity methods. Part 1, LC/GC Magazine, 21(7), 626 (2003). 

14. Krull, I.S., Wang, Y., Orr, J.D., Liu, C. (2003): Derivatization of Phospholipids. Journal of Chromatography B, 793: 3-14. 

15. Wang, Y., Krull, I.S., Orr, J.D., and Liu, C. (2002) Complexation with Iron at sub-ppm levels in the HPLC analyses of phospholipids. Biomedical Chromatography. 17: 1. 

16. Bate, N.J., Orr, J.D., Ni, W., Meromi, A., Nadler-Hassar, T., Doerner, P.W., Dixon, R.A., Lamb, C.J., and Elkind, Y. (1994): Quantitative relationship between phenylalanine ammonia-lyase levels and phenylpropanoid accumulation in transgenic tobacco identifies a rate-determining step in natural product synthesis. Proceedings of the National Academy of Sciences, USA. 91: 7608-7612. 

17. Orr, J.D., Edwards, R, and Dixon, R.A. (1993): Stress responses in Alfalfa (Medicago sativa L.) XIV. Changes in the levels of phenylpropanoid pathway intermediates in relation to regulation of L-phenylalanine ammonia-lyase in elicitor-treated cell suspension cultures. Plant Physiology. 101: 847-856. 



18. Orr, J.D., Sumner, L.W., Edwards, R., and Dixon, R.A. (1993): Determination of cinnamic acid and 4-coumaric acid in alfalfa (Medicago sativa L.) cell suspension cultures by gas chromatography. Phytochemical Analysis. 4: 124-130. 

19. Dixon, R.A., Choudhary, A.D., Dalkin, K., Edwards, R., Fahrendorf, T., Gowri, G., Harrison, M. J. Lamb, C.J., Loake, G.J., Maxwell, C.A., Orr, J.D., and Paiva, N.L. (1991): Molecular biology of stress induced phenylpropanoid biosynthesis in alfalfa. In: Recent Advances in Phytochemistry. Plenum Press, New York, pp. 91-138. 

20. Orr, J.D. and Lynn, D.G. (1991): Biosynthesis of dehydrodiconiferyl alcohol glucosides: Implications for the control of tobacco cell growth. Plant Physiology. 98: 343-352. 

21. Teutonico, R.A., Dudley, M.W., Orr, J.D., Lynn, D.G. and Binns, A.N. (1991): Activity and accumulation of cell division promoting phenolics in tobacco tissue cultures. Plant Physiology 97: 288-297. 

22. Smith, C.E., Orr, J.D., and Lynn, D.G. (1988): Chemical communication and the control of development. In: G.H. Wagman and R. Cooper (Editors), Natural Products Isolation, Journal of Chromatography Library Series, Elsevier Science Publishers, Holland, pp. 557-593. 

23. Weber, S.G. and Orr, J.D. (1985): Establishment and determination of interfacial potentials and stationary phase dielectric constant in reversed-phase liquid chromatography. Journal of Chromatography 322: 433-441.