Search

Your search keyword '"Charles N. Durfor"' showing total 33 results
Start Over Author "Charles N. Durfor"
33 results on '"Charles N. Durfor"'

1. Translation of Regenerative Medicine Products Into the Clinic in the United States

Author

Donald Fink, Michael Mendicino, Mohammad Heidaran, Lynne Boxer, Celia Witten, Charles N. Durfor, Brent McCright, John Hyde, Richard McFarland, Carmen Gacchina Johnson, Diana Yoon, Judith Arcidiacono, Lori Tull, Mark H. Lee, David S. Kaplan, Patrick Au, and Safa Karandish

Subjects
medicine.medical_specialty, Process (engineering), business.industry, Alternative medicine, Regenerative medicine, Product (business), Clinical trial, New product development, medicine, Relevance (law), Engineering ethics, Regulatory science, business, health care economics and organizations
Abstract

The field of regenerative medicine encompasses a breathtaking array of interdisciplinary scientific approaches with the promise of delivering future therapies to meet current unmet medical needs for patients. Increasingly more of these innovative products are being translated into human clinical trials in the United States, and general familiarity of the FDA is important to efficiently navigate the process. The basics of FDA history, organization, and processes are described herein for those new to clinical translation, with more detailed content added regarding approval pathways, regulations, guidances, and select special topics of relevance to regenerative medicine. In addition to the cumulative experience of previous products, the FDA regulatory approach to medical products evaluation includes an ongoing assessment of how the science of those products informs regulatory policy. FDA engages in ongoing dialogue with the scientific community and product sponsors to continue to develop science-based regulatory review policies that are robust and predictable in order to meet the needs of the challenging array of products that are on the horizon.

Published
2015
Full Text
View/download PDF

2. Contributors

Author

Mehran Abolbashari, Jaimo Ahn, Salem Akel, Julie G. Allickson, Graça Almeida-Porada, Judith Arcidiacono, Anthony Atala, Patrick Au, Danielle Aufiero, Pedro M. Baptista, Ronnda L. Bartel, Amelia Bartholomew, Elona Baum, Angie Botto-van Bemden, Khalil N. Bitar, Lynne Boxer, Matthew P. Brown, Heather L. Brown, Stephanie J. Bryant, Pedro P. Carvalho, Prafulla Chandra, John R. Chapman, Shreyasi Das, Daniel B. Deegan, Abritee Dhal, Albert D. Donnenberg, Matthew B. Durdy, Charles N. Durfor, Elazer R. Edelman, Donald Fink, Steven Fischkoff, Joyce L. Frey-Vasconcells, Tobias Führmann, Carmen Gacchina Johnson, Or Gadish, Sanjiv S. Gambhir, Adrian P. Gee, Manuela E. Gomes, Kurt D. Hankenson, Robert J. Hariri, Heather C. Hatcher, Mohammad Heidaran, Ralf Huss, John Hyde, Yoshito Ikada, Deepak Jain, Paul A. Jain, Jesse V. Jokerst, Philipp Jungebluth, Eve Kandyba, David S. Kaplan, Safa Karandish, F. Kurtis Kasper, Sneha S. Kelkar, Norma Kenyon, Krzysztof Kobielak, Jesse Kramer, Sang Jin Lee, Mark H. Lee, Yvonne Leung, Mei Ling Lim, Neil J. Littman, Paolo Macchiarini, Nafees N. Malik, Brenda K. Mann, Kacey G. Marra, Robert E. Marx, Lina Mastrangelo, Brent McCright, Richard McFarland, Michael Mendicino, Antonios G. Mikos, Nikolaos Mitrousis, Aaron M. Mohs, Thomas Moore, Emma C. Moran, Walter Niles, Guoguang Niu, Masashi Nomi, Tamara Nunez, Robert Perry, Robert P. Pfotenhauer, Christopher D. Porada, Kavitha Premenand, Glenn D. Prestwich, Shreya Raghavan, Mahendra Rao, Anthony Ratcliffe, Stephen Rego, Rui L. Reis, Ivan N. Rich, Márcia T. Rodrigues, J. Peter Rubin, Steven Sampson, Etai Sapoznik, John G. Sharp, Molly S. Shoichet, Daniel Skuk, Evan Y. Snyder, Shay Soker, Sita Somara, Tom Spencer, Suzanne Stewart, Premenand Sundivakkam, Erszebet Szilagyi, Alexander M. Tatara, Brian Tobe, Jacques P. Tremblay, Alan O. Trounson, Anup Tuladhar, Lori Tull, Jolene E. Valentin, Dipen Vyas, Zhan Wang, Alicia Winquist, Celia Witten, Mark E.K. Wong, James J. Yoo, Diana Yoon, Elie Zakhem, and Joao Paulo Zambon

Published
2015
Full Text
View/download PDF

3. List of Contributors

Author

Russell C. Addis, Piero Anversa, Judith Arcidiacono, Anthony Atala, Joyce Axelman, Ashok Batra, Helen M. Blau, Susan Bonner-Weir, Mairi Brittan, Hal E. Broxmeyer, Mara Cananzi, Constance Cepko, Tao Cheng, Susana M. Chuva de Sousa Lopes, Gregory O. Clark, Maegen Colehour, Paolo de Coppi, Giulio Cossu, George Q. Daley, Jiyoung M. Dang, Natalie Direkze, Yuval Dor, Gregory R. Dressler, Charles N. Durfor, Ewa C.S. Ellis, Martin Evans, Donna M. Fekete, Donald Fink, Elaine Fuchs, Margaret T. Fuller, Richard L. Gardner, Zulma Gazit, Dan Gazit, John D. Gearhart, Victor M. Goldberg, Rodolfo Gonzalez, Deborah Lavoie Grayeski, Ronald M. Green, Markus Grompe, Stephen L. Hilbert, Marko E. Horb, Jerry I. Huang, Jaimie Imitola, D. Leanne Jones, Jan Kajstura, David S. Kaplan, Pritinder Kaur, Kathleen C. Kent, Candace L. Kerr, Ali Khademhosseini, Nadav Kimelman, Irina Klimanskaya, Jennifer N. Kraszewski, Mark A. LaBarge, Robert Langer, Robert Lanza, Ellen Lazarus, Jean Pyo Lee, Mark H. Lee, Annarosa Leri, Shulamit Levenberg, S. Robert Levine, John W. Littlefield, Richard McFarland, Jill McMahon, Douglas A. Melton, Mary Tyler Moore, Franz-Josef Mueller, Christine L. Mummery, Bernardo Nadal-Ginard, Hitoshi Niwa, Keisuke Okita, Jitka Ourednik, Vaclav Ourednik, Kook I. Park, Ethan S. Patterson, Gadi Pelled, Christopher S. Potten, Sean Preston, Philip R. Roelandt, Valerie D. Roobrouck, Nadia Rosenthal, Janet Rossant, Maurilio Sampaolesi, Maria Paola Santini, David T. Scadden, Holger Schlüter, Gunter Schuch, Michael J. Shamblott, Dima Sheyn, Richard L. Sidman, Evan Y. Snyder, Shay Soker, Stephen C. Strom, Lorenz Studer, M. Azim Surani, Francesco Saverio Tedesco, Yang D. Teng, David Tosh, Alan Trounson, Tudorita Tumbar, Edward Upjohn, George Varigos, Catherine M. Verfaillie, Zhan Wang, Gordon C. Weir, Kevin J. Whittlesey, J. Koudy Williams, James W. Wilson, Celia Witten, Nicholas A. Wright, Shinya Yamanaka, and Jung U. Yoo

Published
2014
Full Text
View/download PDF

4. The Regulatory Process from Concept to Market

Author

Celia Witten, Donald Fink, Charles N. Durfor, Judith Arcidiacono, Alexander M. Bailey, Becky Robinson, Richard McFarland, Patricia Holobaugh, Rachael Anatol, Steve Winitsky, and Mark H. Lee

Subjects
Process (engineering), business.industry, Investigational New Drug Application, Pharmacology, Key issues, humanities, Food and drug administration, Product (business), Clinical research, Late phase, Clinical investigation, Medicine, Engineering ethics, business, health care economics and organizations
Abstract

The US Food and Drug Administration (FDA) is responsible for the regulatory oversight of a wide range of products, including cell-based products regulated by the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research. This chapter focuses on several key issues relevant to the development of cell-based products, including early and late phase considerations for chemistry, manufacturing, and controls; pharmacology/toxicology; and clinical testing. This chapter introduces the following topics: the regulatory process, sponsor meetings with OTAT, the requirements for submitting an investigational new drug application (IND), and FDA review of an original IND submission. Also discussed are combination products, tissue-engineered/regenerative medicine products, medical devices, special regulatory considerations such as clinical research involving children, responsibilities of sponsors and investigators, and the use of standards. Knowledge and consideration of the topics discussed in this chapter may aid in the development of cell-based product.

Published
2014
Full Text
View/download PDF

5. List of Contributors

Author

Robby D. Bowles, Anthony J. (Tony) Smith, Jon D. Ahlstrom, Julie Albon, Peter G. Alexander, Richard A. Altschuler, Pedro Alvarez, A. Amendola, Rachael Anatol, Nasim Annabi, Piero Anversa, Judith Arcidiacono, Anthony Atala, Kyriacos A. Athanasiou, François A. Auger, Debra T. Auguste, Hani A. Awad, Stephen F. Badylak, Alexander M. Bailey, Michael P. Barry, Daniel Becker, Visar Belegu, Jonathan Bernhard, Timothy Bertram, Valérie Besnard, Z.F. Bhat, Hina Bhat, Sangeeta N. Bhatia, Sarindr Bhumiratana, Paolo Bianco, Catherine Clare Blackburn, Thomas Bollenbach, Lawrence A. Bonassar, Mike Boulton, Amy D. Bradshaw, Christopher K. Breuer, Luke Brewster, Eric M. Brey, Mairi Brittan, Bryan N. Brown, T. Brown, J.A. Buckwalter, Deborah Buffington, Karen J.L. Burg, Timothy C. Burg, Stéphane Chabaud, Thomas Ming Swi Chang, Yunchao Chang, Robert G. Chapman, Fa-Ming Chen, Una Chen, Elisa Cimetta, Richard A.F. Clark, Karen L. Clark, Muriel A. Cleary, Réjean Cloutier, Clark K. Colton, George Cotsarelis, Ronald G. Crystal, Gislin Dagnelie, Lino da Silva Ferreira, Jeffrey M. Davidson, Thomas F. Deuel, Natalie Direkze, Gregory R. Dressler, Charles N. Durfor, Craig L. Duvall, George Eng, George Engelmayr, Thomas Eschenhagen, Mark Eu-Kien Wong, Vincent Falanga, Katie Faria, Denise L. Faustman, Dario O. Fauza, Qiang Feng, Lino Ferreira, Donald W. Fink, William Fissell, Lisa E. Freed, Mark E. Furth, Denise Gay, Sharon Gerecht-Nir, Lucie Germain, Charles A. Gersbach, Francine Goulet, Ritu Goyal, Maria B. Grant, Howard P. Greisler, Farshid Guilak, Brendan A.C. Harley, David A. Hart, Abdelkrim Hmadcha, Steve J. Hodges, Heidi R. Hofer, Jeffrey O. Hollinger, Patricia Holobaugh, Jeffrey A. Hubbell, H. David Humes, Donald E. Ingber, Beau Inskeep, Xingyu Jiang, Jan Kajstura, Ravi S. Kane, Jeffrey M. Karp, F. Kurtis Kasper, Ali Khademhosseini, Sven Kili, Erin A. Kimbrel, Irina Klimanskaya, Joachim Kohn, Shaun M. Kunisaki, Themis R. Kyriakides, Eric Lagasse, Jean Lamontagne, Robert Langer, Robert Lanza, Shimon Lecht, Benjamin W. Lee, Chang H. Lee, Mark H. Lee, Peter I. Lelkes, Annarosa Leri, David W. Levine, Feng Li, Michael T. Longaker, Javier López, Shi-Jiang Lu, Ying Luo, Ben D. MacArthur, Nancy Ruth Manley, Rohan Manohar, Jonathan Mansbridge, Athanasios Mantalaris, Jeremy J. Mao, J.L. Marsh, David C. Martin, J.A. Martin, M. Martins-Green, Koichi Masuda, Mark W. Maxfield, Kathryn L. McCabe, John W. McDonald, Richard McFarland, Antonios G. Mikos, José del R. Millán, Josef M. Miller, Shari Mills, Kristen L. Moffat, Mark J. Mondrinos, Daniel T. Montoro, Malcolm A.S. Moore, Rebekah A. Neal, Robert M. Nerem, Shengyong Ng, Craig Scott Nowell, Haruko Obokata, Bjorn Reino Olsen, Richard O.C. Oreffo, Regis J. O’Keefe, Kathy O’Neill, Ophir Ortiz, Carolyn K. Pan, Vikas Pathak, M. Petreaca, Daniela Pezzolla, Maksim V. Plikus, Julia M. Polak, Mark Post, Sean Preston, Aleš Prokop, Milica Radisic, Egon Ranghini, Yehoash Raphael, A.H. Reddi, Herrmann Reichenspurner, Ellen Richie, Pamela Gehron Robey, Becky Robinson, Anabel Rojas, Shuvo Roy, Alan J. Russell, Rajiv Saigal, W. Mark Saltzman, Ali Samadikuchaksaraei, Athanassios Sambanis, Jochen Schacht, Stacey C. Schutte, Lyndsey Schutte, Steven D. Schwartz, Robert E. Schwartz, Lori A. Setton, Su-Hua Sha, Jing Shan, Paul T. Sharpe, Songtao Shi, Arun R. Shrivats, Franck Simon, Dario Sirabella, J.M.W. Slack, Bernat Soria, Patrick Spicer, Kelly R. Stevens, Frank E. Stockdale, H. Christiaan Stronks, Lorenz Studer, Shuichi Takayama, James A. Thomson, Jordan E. Trachtenberg, Elsa Treffeisen, Rocky S. Tuan, Charles A. Vacanti, Joseph P. Vacanti, Cor van der Weele, Matthew Vincent, Gordana Vunjak-Novakovic, Lars U. Wahlberg, Derrick C. Wan, Anne Wang, Angela J. Westover, George M. Whitesides, Jeffrey A. Whitsett, Steve Winitsky, Celia Witten, Stefan Worgall, Nicholas A. Wright, Ioannis V. Yannas, Simon Young, Junying Yu, Zheng Zhang, Wenfu Zheng, Wolfram Hubertus Zimmermann, and Laurie Zoloth

Published
2014
Full Text
View/download PDF

6. Contributors

Author

Piero Anversa, Judith Arcidiacono, Anthony Atala, Yann Barrandon, Ashok Batra, Daniel Becker, Nicole M. Bergmann, Paolo Bianco, Helen M. Blau, Susan Bonner-Weir, Mairi Brittan, Hal E. Broxmeyer, Mara Cananzi, Arnold I. Caplan, Constance Cepko, Maegen Colehour, Giulio Cossu, George Q. Daley, Jiyoung M. Dang, Ayelet Dar, Brian R. Davis, Paolo de Coppi, Natalie Direkze, Juan Domínguez-Bendala, Yuval Dor, Gregory R. Dressler, Charles N. Durfor, Rita B. Effros, Ewa C.S. Ellis, Margaret A. Farley, Donna M. Fekete, Qiang Feng, Donald Fink, Elaine Fuchs, Dan Gazit, Zulma Gazit, Sharon Gerecht, Victor M. Goldberg, Rodolfo Gonzalez, François Gorostidi, Elizabeth Gould, Nicolas Grasset, Deborah Lavoie Grayeski, Ronald M. Green, Markus Grompe, Joshua M. Hare, Konstantinos E. Hatzistergos, Kevin E. Healy, Stephen L. Hilbert, Jerry I. Huang, James Huettner, Jaimie Imitola, Elizabeth F. Irwin, Joseph Itskovitz-Eldor, Josephine Johnston, Jan Kajstura, David S. Kaplan, Adam J. Katz, Pritinder Kaur, Erin A. Kimbrel, Nadav Kimelman, Chris Kintner, Naoko Koyano-Nakagawa, Tilo Kunath, Mark A. LaBarge, Robert Lanza, Stéphanie Lathion, Ellen Lazarus, Jean Pyo Lee, Mark H. Lee, Annarosa Leri, S. Robert Levine, Feng Li, Shi-Jiang Lu, John W. McDonald, Richard McFarland, Melissa K. McHale, Douglas A. Melton, Alexander F. Mericli, Christian Mirescu, Malcolm A.S. Moore, Mary Tyler Moore, Franz-Josef Mueller, Bernardo Nadal-Ginard, Jitka Ourednik, Vaclav Ourednik, Kook I. Park, Gadi Pelled, Antonello Pileggi, Jacob F. Pollock, Christopher S. Potten, Sean Preston, Nicole L. Prokopishyn, Camillo Ricordi, Pamela Gehron Robey, Ariane Rochat, Philip R. Roelandt, Valerie D. Roobrouck, Nadia Rosenthal, Janet Rossant, Maurilio Sampaolesi, Maria Paola Santini, David V. Schaffer, Holger Schlüter, Gunter Schuch, Sarah Selem, Dima Sheyn, Richard L. Sidman, Daniel Skuk, Evan Y. Snyder, Shay Soker, Stephen C. Strom, Lorenz Studer, Francesco Saverio Tedesco, Yang D. Teng, Jacques P. Tremblay, Tudorita Tumbar, Edward Upjohn, George Varigos, Catherine M. Verfaillie, Zhan Wang, Gordon C. Weir, Jennifer L. West, Kevin J. Whittlesey, J. Koudy Williams, J.W. Wilson, Celia Witten, Nicholas A. Wright, and Jung U. Yoo

Published
2013
Full Text
View/download PDF

7. Formation and naphthoyl derivatization of aromatic aminosilane self-assembled monolayers: characterization by atomic force microscopy and ultraviolet spectroscopy

Author

Brian M. Peek, David C. Turner, David A. Stenger, Jacque H. Georger, and Charles N. Durfor

Subjects
Chemistry, Self-assembled monolayer, Surfaces and Interfaces, Condensed Matter Physics, Photochemistry, Characterization (materials science), chemistry.chemical_compound, Ultraviolet visible spectroscopy, Diamine, Monolayer, Electrochemistry, Organic chemistry, General Materials Science, Reactivity (chemistry), Wetting, Derivatization, Spectroscopy
Published
1994
Full Text
View/download PDF

8. Contributors

Author

Tamer Aboushwareb, Jon D. Ahlstrom, Alejandro J. Almarza, James M. Anderson, Judith Arcidiacono, Anthony Atala, Stephen F. Badylak, Jae Hyun Bae, Brian G. Ballios, Ashok Batra, M. Douglas Baumann, Ravi V. Bellamkonda, Nicole M. Bergmann, Mickie Bhatia, Martin A. Birchall, Helen M. Blau, Joel D. Boerckel, Ali H. Brivanlou, Mara Cananzi, Arnold I. Caplan, Joseph W. Carnwath, Grant A. Challen, George J. Christ, Hyun Jung Chung, Maegen Colehour, Michael J. Cooke, V.M. Correlo, Benjamin D. Cosgrove, Stefano Da Sacco, Jiyoung M. Dang, Richard M. Day, Paolo De Coppi, Roger E. De Filippo, Mahesh C. Dodla, Juan Domínguez-Bendala, Ryan P. Dorin, Charles N. Durfor, Rita B. Effros, Jennifer H. Elisseeff, Ewa C.S. Ellis, Juliet A. Emamaullee, Per Fagerholm, Qiang Feng, Donald Fink, Matthew B. Fisher, Andrés J. García, Svetlana Gavrilov, Dan Gazit, Zulma Gazit, Christopher V. Gemmiti, Charles A. Gersbach, Margaret A. Goodell, Deborah Lavoie Grayeski, Ronald M. Green, May Griffith, Robert E. Guldberg, Qiongyu Guo, M.C. Hacker, Joanne Hackett, Joshua M. Hare, Benjamin S. Harrison, Konstantinos E. Hatzistergos, Kevin E. Healy, Stephen L. Hilbert, Jiang Hu, Alexander Huber, H. David Humes, Elizabeth F. Irwin, Brett C. Isenberg, Takanori Iwata, Sam Janes, Lily Jeng, Junfeng Ji, Josephine Johnston, Kimberly A. Johnston, David L. Kaplan, David S. Kaplan, Sinan Karaoglu, Adam J. Katz, Jaehyun Kim, Erin A. Kimbrel, Nadav Kimelman, Jonathan A. Kluge, Chester J. Koh, Yash M. Kolambkar, Makoto Komura, Wilfried A. Kues, Francois Ng kee Kwong, Neil Lagali, Deepak A. Lamba, Donald W. Landry, Robert Lanza, Barrett Larson, Malcolm A. Latorre, Ellen Lazarus, Hyukjin Lee, Mark H. Lee, Sang Jin Lee, Gary G. Leisk, Feng Li, Rui Liang, Kuanyin K. Lin, Xiaohua Liu, Michael T. Longaker, H. Peter Lorenz, Shi-Jiang Lu, Andrea Lucas-Hahn, Peter X. Ma, Paolo Macchiarini, Masood A. Machingal, J.F. Mano, M. Martins-Green, Michael McCall, Richard McFarland, Melissa K. McHale, Alexander F. Mericli, A.G. Mikos, Vivek J. Mukhatyar, Allison Nauta, N.M. Neves, Heiner Niemann, Teruo Okano, Keisuke Okita, J.M. Oliveira, Virginia E. Papaioannou, Tae Gwan Park, Gadi Pelled, Laura Perin, M. Petreaca, Antonello Pileggi, Jacob F. Pollock, Blaise D. Porter, Milica Radisic, Nandini Rao, A.H. Reddi, Thomas A. Reh, R.L. Reis, Camillo Ricordi, Philip Roelandt, Caroline Beth Sangan, Justin M. Saul, David V. Schaffer, Gunter Schuch, Michael V. Sefton, Sarah Selem, A.M. James Shapiro, Heather Sheardown, Dima Sheyn, Molly S. Shoichet, Harvir Singh, Sirinrath Sirivisoot, Daniel Skuk, Shay Soker, Myron Spector, David L. Stocum, Stephen C. Strom, James A. Thomson, David Tosh, Robert T. Tranquillo, Jacques P. Tremblay, Catherine M. Verfaillie, Zhan Wang, Jennifer L. West, Kevin J. Whittlesey, Chrysanthi Williams, David F. Williams, J. Koudy Williams, Celia Witten, Savio L.-Y. Woo, Fiona Wood, Shinya Yamanaka, Masayuki Yamato, Saami K. Yazdani, James J. Yoo, Junying Yu, and Bonan Zhong

Published
2011
Full Text
View/download PDF

9. Overview of the FDA Regulatory Process

Author

David S. Kaplan, Donald Fink, Ashok Batra, Judith Arcidiacono, Richard McFarland, Celia Witten, Charles N. Durfor, Jiyoung M. Dang, Mark H. Lee, Maegen Colehour, Deborah Lavoie Grayeski, Stephen L. Hilbert, Kevin J. Whittlesey, and Ellen Lazarus

Subjects
Engineering, Sociology of scientific knowledge, Process (engineering), business.industry, Investigational New Drug, Guidance documents, Accounting, Guideline, Regenerative medicine, Public health service, Clinical research, Knowledge base, Code of Federal Regulations, Infectious disease (medical specialty), Cardiac valve, Medicine, Operations management, Regulatory science, Engineering ethics, Organizational structure, Business, Eligibility Determination, Enforcement
Abstract

Publisher Summary This chapter provides a brief historical review of the Food and Drug Administration (FDA) and its organizational structure and discusses topics pertaining to the regulation of regenerative medicine products including possible regulatory pathways for combination products and relevant jurisdictional issues. FDA regulations are contained in the Code of Federal Regulations (CFR). Regulations for drugs, biologics, devices, and tissues, along with related regulations, may be found in various parts of Title 21 of the CFR. Guidance documents are nonbinding publications that describe the FDA's interpretation of policy pertaining to a regulatory issue or set of issues related to the design, production, labeling, promotion, manufacturing, and testing of regulated products, the processing, content, and evaluation, or approval of submissions inspection, and enforcement policies. Guidance documents, which are developed in accordance with Good Guidance Practices found at 21 CFR §10.115, are intended to clarify the FDA's current thinking related to regulatory issues and procedures. The FDA has issued “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products to assist establishments making donor eligibility determinations with complying with the Donor Eligibility rule (21 CFR 1271 Subpart C).” This guidance also incorporates and finalizes the content of “Guidance for Industry, Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt–Jakob Disease (CJD) and Variant Creutzfeldt–Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The US Public Health Service (PHS) agencies including the FDA, National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Health Resources and Services Administration (HRSA) have worked together to address the risk of infectious disease transmission, publishing the “PHS Guideline on Infectious Disease Issues in Xenotransplantation.”

Published
2011
Full Text
View/download PDF

10. An FDA Perspective of Manufacturing Changes for Products in Human Use

Author

Charles N. Durfor and Curtis L. Scribner

Subjects
Vaccines, Synthetic, United States Food and Drug Administration, General Neuroscience, Perspective (graphical), Antibodies, Monoclonal, Models, Theoretical, Data science, Recombinant Proteins, United States, General Biochemistry, Genetics and Molecular Biology, History and Philosophy of Science, Human use, Culture Techniques, Cytokines, Humans, Business, Biotechnology
Published
1992
Full Text
View/download PDF

11. Regulatory considerations when developing biological products

Author

Curtis L. Scribner, Robert W. Kozak, and Charles N. Durfor

Subjects
Risk analysis (engineering), Clinical Biochemistry, Immunology, Biomedical Engineering, Bioengineering, Cell Biology, Guideline, Biology, Biotechnology, Regulatory authority
Abstract

The Center for Biologics Evaluation and Research, whose regulatory authority includes monoclonal antibodies, cytokines, vaccines, toxins and somatic cellular therapies, communicates to sponsors issues for consideration in the development of biological products through the publication of “Points to Consider” and “Guideline” documents. This paper summarizes the available “Points to Consider” and “Guideline” documents and outlines recommendations from these documents for characterizing the cells used to produce biological products.

Published
1992
Full Text
View/download PDF

12. Screening biomaterials for stimulation of nitric oxide-mediated inflammation

Author

Charles N. Durfor, Daniel B. Lyle, John J. Langone, Jonathan C. Shallcross, Victoria M. Hitchins, and Joyce C. Breger

Subjects
Lipopolysaccharides, Materials science, Lipopolysaccharide, Biomedical Engineering, Inflammation, Stimulation, Biocompatible Materials, Pharmacology, Nitric Oxide, Nitric oxide, law.invention, Cell Line, Biomaterials, chemistry.chemical_compound, Interferon-gamma, Mice, law, 2-Naphthylamine, Hyaluronic acid, Materials Testing, medicine, Macrophage, Animals, Humans, Parthenolide, Hyaluronic Acid, Nitrites, Macrophages, Anti-Inflammatory Agents, Non-Steroidal, Metals and Alloys, chemistry, Immunology, Ceramics and Composites, Recombinant DNA, medicine.symptom, Sesquiterpenes
Abstract

Inflammatory reactions to biomaterials may include macrophage-mediated generation of nitric oxide (NO), which may harm patient tissue or potentially interfere with proper function of an implanted device. RAW 264.7 cells were grown in culture and treated at various times with lipopolysaccharide (LPS, endotoxin), murine recombinant γ-interferon (mrIFN-γ), and different preparations of hyaluronic acid (HA). Increase in fluorescence of 2,3-diaminonaphthalene (DAN) allowed for detection of initial (24 h or less) NO inflammatory responses of RAW 264.7 to LPS from E. coli O26:B6. By looking at early time points, mrIFN-γ augmentation of the LPS effect was observed, simulating a complex immune reaction. Activation through nuclear factor-κB (NF-κB), was confirmed in this system by parthenolide inhibition of LPS stimulation. Stimulation of RAW 264.7 by different HA preparations resulted in NO responses that correlated with the amount of LPS present. In the presence of mrIFN-γ, a significant inflammatory reaction to HA was observed when the concentration of contaminating LPS was as low as 0.15 EU/mL. NO production in the presence of mrIFN-γ by RAW 264.7 may serve as a convenient in vitro system to routinely screen biomaterials for potentially harmful macrophage-mediated inflammation whereby the safety of implanted medical devices might be compromised. © 2008 Wiley Periodicals, Inc. J Biomed Mater Res, 2009

Published
2008

13. Overview of FDA Regulatory Process

Author

Donald Fink, Charles N. Durfor, Stephen L. Hilbert, David S. Kaplan, Deborah Lavoie, Ashok Batra, Celia Witten, Ellen Maher, and Richard McFarland

Subjects
Process management, Process (engineering), business.industry, Medicine, business
Published
2008
Full Text
View/download PDF

14. List of Contributors

Author

Jon D. Ahlstrom, Taby Ahsan, Julie Allickson, Alejandro J. Almarza, James M. Anderson, Peter Andrews, Hadi Aslan, Anthony Atala, Stephen F. Badylak, Ashok Batra, M. Douglas Baumann, Ravi V. Bellamkonda, Nicole M. Bergman, Z. Beyhan, Mickie Bhatia, Sangeeta N. Bhatia, Peter M. Black, Helen Blau, Scott D. Boden, Eric M. Brey, Ali H. Brivanlou, Chris R. Brown, Scott P. Bruder, S.M. Chambers, Christopher S. Chen, LiHow Chen, Mike Chen, Sulin Chen, N. Cheng, George J. Christ, Seyung Chung, J.B. Cibelli, Massimo Cimini, Paolo De Coppi, Mahesh C. Dodla, Juan Dominguez-Bendala, AM Doyle, Charles N. Durfor, Yann Echelard, Rita B. Effros, Jennifer Elisseeff, Ewa C.S. Ellis, Juliet A. Emamaullee, Carol A. Erickson, Roger De Filippo, Donald Fink, William H. Fissell, Gary E. Friedlaender, Mark E. Furth, Yossi Gafni, Keneth Gage, Andres Garcia, William Gavin, Daniel Gazit, Zulma Gazit, Christopher S. Gemmiti, Jörg C. Gerlach, Paul J. Gokhale, M.A. Goodell, May Griffith, Louis M. Guenin, Stefano Giuliani, Robert E. Guldberg, M.C. Hacker, Benjamin S. Harrison, Bernd Hartmann, Stephen H. Hilbert, Alexander Hillel, Jason Hipp, Col. J.B. Holcomb, Jeffrey O. Hollinger, Chantal E. Holy, Mariah Hout, Jiang Hu, George T.-J. Huang, Johnny Huard, Elliot E. Hui, H. David Humes, Marcos Intaglietta, Junfeng Ji, Yueha Jiang, Christa Johnen, Josephine Johnston, Akira Joraku, David L. Kaplan, David S. Kaplan, Gilson Khang, Rehan N. Khanzada, Soon Hee Kim, Moon Suk Kim, Nadav Kimelman, Irina Klimanskaya, Jonathan A. Kluge, Yash Kolambkar, Chester J. Koh, Makoto Komura, Douglas Kondziolka, Deniz Konya, Wilfried A. Kues, Francois Ng kee Kwong, Deepak Lamba, Hai Bang Lee, Hyukjin Lee, Gary G. Leisk, Kam W. Leong, Ariel J. Levine, Ren Ke Li, Wan-Ju Li, Grace J. Lim, Yan Lin, William J. Lindblad, Wendy F. Liu, Xiaohua Liu, Andrea Lucas-Hahn, Aernout Luttun, Samuel Lynch, Peter X. Ma, Ellen Maher, Manuela Martins-Green, Randall E. McClelland, Richard McFarland, Larry V. McIntire, Harry Meade, David L. Melican, A.G. Mikos, Fernando Ulloa Montoya, Robert M. Nerem, Heiner Niemann, Aparna Nori, Patrea L. Pabst, Kook In Park, Tae Gwan Park, David P. Patterson, Karen Pauwelyn, Gadi Pelled, Laura Perin, M. Petreaca, Antonello Pileggi, Jason H. Pomerantz, Blaise Porter, Milica Radisic, Buddy D. Ratner, A. Hari Reddi, Thomas A. Reh, Lola M. Reid, Camillo Ricordi, Jeff Ross, Alan J. Russell, Filipe N.C. Santos, John P. Schmitz, Gunter Schuch, Sargis Sedrakyan, Michael V. Sefton, Marta Serafini, Paulesh Shah, A.M. James Shapiro, Heather Sheardown, Molly S. Shoichet, M. Minhaj Siddiqui, Richard L. Sidman, Ronald Silverman, Daniel Skuk, Evan Snyder, Shay Soker, Myron Spector, David L. Stocum, Stephen C. Strom, Doris A. Taylor, Yang D. Teng, James Thomson, Robert T. Tranquillo, Jacques P. Tremblay, Amy Tsai, Rocky S. Tuan, Ross S. Tubo, Mark Van Dyke, Deborah Vavoie, Catherine Verfaillie, F. Jerry Volenec, Sara Wargo, Joseph W. Warnwath, Lawrence Wechsler, Shen Wei, Richard D. Weisel, Jennifer L. West, Chrysanthi Williams, J. Koudy Williams, Celia Witten, Steven E. Wolf, Savio L.-Y. Woo, Jordan H. Wosnick, Christine Wrenzycki, Munira Xaymardan, Hsin-Lei Yao, Saami K. Yazdani, Pamela C. Yelick, James J. Yoo, Junying Yu, Katrin Zeilinger, Lepeng Zeng, Andrey G. Zenovich, Bonan Zhong, Carol A. Ziomek, and Laurie Zoloth

Published
2008
Full Text
View/download PDF

15. Potentiometric biosensor employing catalytic antibodies as the molecular recognition element

Author

Anthony R. Rees, David B. Talley, Charles N. Durfor, Gary F. Blackburn, Andrew D. Napper, Mark T. Martin, and Paul M. Booth

Subjects
Detection limit, chemistry.chemical_classification, Chemistry, Phenyl acetate, Hydrolysis, Biomolecule, Antibodies, Monoclonal, Substrate (chemistry), Biosensing Techniques, Hydrogen-Ion Concentration, Combinatorial chemistry, Analytical Chemistry, Catalysis, chemistry.chemical_compound, Molecular recognition, Potentiometry, Electroanalytical method, Organic chemistry, Biosensor
Abstract

Catalytic antibodies are introduced as an important new class of biomolecules for molecular recognition in biosensors in which the binding sites are continually regenerated by the catalytic reaction of the substrate. Consequently, molecular recognition by catalytic antibodies can yield reversible immunoblosensors. In this example, a prototype potentiometric biosensor is described in which a micro-pH electrode is modified with a catalytic antibody that catalyzes the hydrolysis of phenyl acetate, producing hydrogen ions that can be monitored by the electrode. The reversible response is linear with the log of substrate concentration over a range of 20-500 microM with a detection limit of 5 microM under the conditions of this study. Alternative applications of catalytic antibodies in other biosensor configurations are discussed.

Published
1990
Full Text
View/download PDF

16. REGULATORY CONSIDERATIONS

Author

Ruth R. Solomon, Charles N. Durfor, John G. Bishop, Claudia Gaffey, and Kiki B. Hellman

Subjects
Engineering, business.industry, business
Published
2000
Full Text
View/download PDF

17. CONTRIBUTORS

Author

Patrick Aebischer, Richard A. Altschuler, Pascal Ambrosini, David J. Anderson, Anthony Atala, François A. Auger, Efstathios S. Avgoustiniatos, David W. Barnes, Eugene Bell, Marie C. Béné, John G. Bishop, T. Bohrer, Lawrence J. Bonassar, Amy D. Bradshaw, Kelvin G.M. Brockbank, Leon W. Browder, Scott P. Bruder, Mary Bartlett Bunge, Arnold I. Caplan, Thomas Ming Swi Chang, Robert G. Chapman, Una Chen, Richard A.F. Clark, Réjean Cloutier, Clark K. Colton, Joanne C. Cousins, Stephen C. Cowin, Gislin Dagnelie, Thomas F. Deuel, Charles N. Durfor, Brian E. Edwards, Carol A. Erickson, Gilbert C. Faure, Denise Faustman, Dario O. Fauza, Eric G. Fine, Lee G. Fradkin, Lisa E. Freed, Claudia Gaffey, John D. Gearhart, Lucie Germain, Francine Goulet, Howard P. Greisler, Alan J. Grodzinsky, Craig R. Halberstadt, Janet Hardin-Young, C. Hasse, Matthias Hebrok, Kiki B. Hellman, Walter D. Holder, Edward Hsu, Jeffrey A. Hubbell, Mark S. Humayun, H. David Humes, Donald E. Ingber, Hugo O. Jauregui, Roger D. Kamm, Ravi S. Kane, Jens O.M. Karlsson, Anne Kessinger, Byung-Soo Kim, Naomi Kleitman, Joachim Kohn, Hiroshi Kubota, Robert P. Lanza, Douglas A. Lauffenburger, Kuen Yong Lee, Peter I. Lelkes, Robert E. London, Jack W. Love, Thomas L. Luntz, Michael J. Lysaght, Jeffrey M. Macdonald, Manuela Martins-Green, Robert W. Massof, John M. McPherson, Douglas A. Melton, Antonios G. Mikos, Josef M. Miller, Neal A. Miller, David J. Mooney, Jennifer E. Morgan, Melvin L. Moss, Claudy Mullon, Christopher S. Muratore, Gail K. Naughton, Robert M. Nerem, Björn Reino Olsen, Gregory M. Organ, James M. Pachence, Nancy L. Parenteau, Terence A. Partridge, Jacques Penaud, A. Robin Poole, Denis Rancourt, Yehoash Raphael, A.H. Reddi, Lola M. Reid, J. Dezz Ropp, Robert N. Ross, M. Rothmund, R. Bruce Rutherford, E. Helene Sage, Jacqueline Sagen, W. Mark Saltzman, Gordon H. Sato, Jochen Schacht, Michael J. Shamblott, Graham Sharp, Albert K. Shung, Adam J. Singer, Barry A. Solomon, Ruth R. Solomon, Susan J. Sullivan, Shuichi Takayama, Jeffrey Teumer, Robert C. Thomson, Mehmet Toner, Vickery Trinkaus-Randall, Ross Tubo, Brian R. Unsworth, Charles A. Vacanti, Joseph P. Vacanti, Martin P. Vacanti, Robert F. Valentini, Gordana Vunjak-Novakovic, Lars U. Wahlberg, Taylor G. Wang, John F. Warner, George M. Whitesides, Jay M. Wilson, Haiyun Wu, Arron S.L. Xu, Lian Xue, Ioannis V. Yannas, Michael J. Yaszemski, Nan Zhang, Beth A. Zielinski, A. Zielke, and U. Zimmerman

Published
2000
Full Text
View/download PDF

18. Tissue Engineering

Author

Charles N. Durfor, Kiki B. Hellman, and Emma Knight

Subjects
0106 biological sciences, Engineering, Tissue engineered, Product design, business.industry, Biomimetic design, Organ function, Computational biology, 01 natural sciences, 3. Good health, Synthetic materials, Biotechnology, Food and drug administration, 03 medical and health sciences, 0302 clinical medicine, Tissue engineering, 030212 general & internal medicine, business, 010606 plant biology & botany
Abstract

Publisher Summary The Food and Drug Administration (FDA) recognizes that an important segment of the products that it regulates arises from new technological achievements and innovations. One example is products developed through tissue engineering (TE) technology, i.e., tissue engineered medical products. Tissue engineering is the application of the principles of life sciences and engineering to develop biological substitutes for the restoration, maintenance, modification, improvement, or replacement of tissue or organ function. In the broadest sense, tissue engineered medical products span a spectrum of products including transplanted human tissues or organs (i.e., autologous or allogeneic tissue); animal tissues or organs (e.g., transgenic animals or xenotransplants); processed, selected, or expanded mammalian cells (e.g., somatic and genetic cellular therapies) in combination with or without biomaterials; and totally synthetic materials of biomimetic design. Both the range of products and the rapid evolution in product design have generated a certain degree of ambiguity in the definition of tissue engineered medical products. There is no precise and globally accepted definition for tissue-engineered products (TEPs).

Published
1998
Full Text
View/download PDF

19. Electron paramagnetic resonance studies of the tungsten-containing formate dehydrogenase from Clostridiumthermoaceticum

Author

Gerald D. Watt, Charles N. Durfor, Phyllis J. Wetherbee, Edward I. Solomon, and Joseph C. Deaton

Subjects
Ligand field theory, Potentiometric titration, Biophysics, Analytical chemistry, Formate dehydrogenase, Biochemistry, Redox, Tungsten, law.invention, law, Cluster (physics), Molecule, Electron paramagnetic resonance, Molecular Biology, Clostridium, Binding Sites, biology, Chemistry, Electron Spin Resonance Spectroscopy, Temperature, Active site, Cell Biology, Aldehyde Oxidoreductases, Formate Dehydrogenases, Crystallography, biology.protein, Oxidation-Reduction
Abstract

The redox centers in the tungsten-containing formate dehydrogenase from Clostridium thermoaceticum were examined by potentiometric titration and electron paramagnetic resonance spectroscopy. At low temperature two overlapping iron-sulfur signals which correlated with enzymatic activity were observed with formal potentials near-400 mV vs. SHE. Based on their temperature dependences, one signal is assigned to a reduced Fe2S2 cluster and one to a reduced Fe4S4 cluster. Quantitation of signal intensity suggests two Fe2S2 and two Fe4S4 clusters per formate dehydrogenase molecule. Another signal (g= 2.101, 1.980, 1.950) present in low concentrations at more negative potentials was observable up to 200°K and is not attributed to any iron-sulfur cluster. The possible orgin of this signal is analyzed using ligand field theory, and the redox behavior is considered with respect to possible ligation at the active site.

Published
1987
Full Text
View/download PDF

20. Activation of nit-1 nitrate reductase by W-formate dehydrogenase

Author

Edward I. Solomon, Deloria B. Jacobs, Barbara K. Burgess, Joseph C. Deaton, Phyllis J. Wetherbee, and Charles N. Durfor

Subjects
Biophysics, Formate dehydrogenase, Nitrate reductase, Biochemistry, Cofactor, chemistry.chemical_compound, Tungstate, Nitrate Reductases, Sulfite oxidase, Nitrogenase, Molecular Biology, Clostridium, Neurospora crassa, biology, Active site, Cell Biology, equipment and supplies, biology.organism_classification, Aldehyde Oxidoreductases, Formate Dehydrogenases, Enzyme Activation, chemistry, Azotobacter vinelandii, Azotobacter, biology.protein
Abstract

Formate dehydrogenase ( FDH ) from Clostridium thermoaceticum is a known tungsten enzyme. FDH was tested for the presence of nitrogenase-type cofactor and nitrate reductase-type cofactor by the Azotobacter vinelandii UW-45 and Neurospora crassa nit-1 reconstitution assays, respectively. Tungsten formate dehydrogenase (W- FDH ), containing only a small Mo impurity, activated the nit-1 nitrate reductase extracts when molybdate was also added, but not when tungstate was added. These results show W- FDH contains the cofactor common to all known Mo-enzymes except nitrogenase. The difference between the redox chemistries of W- FDH and W-substituted sulfite oxidase appears to relate to differences in tungsten ligation other than that donated by the cofactor or to variations in the protein environment surrounding the tungsten active site.

Published
1984
Full Text
View/download PDF

21. Attachment of riboflavin derivatives to electrode surfaces

Author

Mark L. Bowers, Charles N. Durfor, and Barbara A. Yenser

Subjects
chemistry, Electrode, Inorganic chemistry, chemistry.chemical_element, Moiety, heterocyclic compounds, Riboflavin, Flavin group, Cyclic voltammetry, Electrochemistry, Platinum, Photochemistry, Electrode potential
Abstract

A procedure is described for the site-specific immobilization of riboflavin cofactors on platinum, gold and carbon electrode surfaces. The cofactors were bound to each electrode surface through the 8-methyl group of the flavin moiety. Stable monolayer coverages of flavin coenzymes were formed by initially coating each electrode surface with 3-mercaptopropylsilane followed by reaction with 8-α-bromo- O -tetra-acetylriboflavin. The mild derivatization conditions developed in this study were necessary to avoid competing side reactions, including the decomposition of flavin derivatives. Different methods of synthesizing these flavin-silane-modified electrodes were examined. In addition, the potential versus pH behavior of these flavin-modified electrodes is reported.

Published
1988
Full Text
View/download PDF

22. The reversible inactivation of the Clostridium thermoaceticum formate dehydrogenase by butanedione

Author

Lisa S. Thornton, Charles N. Durfor, and Phyllis J. Wetherbee

Subjects
chemistry.chemical_classification, biology, Sodium formate, Biophysics, Chemical modification, Formate dehydrogenase, Biochemistry, Combinatorial chemistry, Formate oxidation, Cofactor, Amino acid, chemistry.chemical_compound, Enzyme, chemistry, Structural Biology, biology.protein, Sodium azide, Molecular Biology
Abstract

2,3-Butanedione reacts with the formate dehydrogenase from Clostridium thermoaceticum to inactivate selectively the reduction of the physiological electron acceptor, NADP, without altering the rates of methyl viologen reduction or formate oxidation. Chemical modification of this extremely oxygen-sensitive formate dehydrogenase is reversible and obeys pseudo-first-order kinetics with respect to inactivator concentration. The presence of sodium azide and NADP protects the enzyme from inactivation. In contrast, enzymatic incubation with sodium formate or sodium bicarbonate does not retard the rate of enzymatic activity loss. From these results we conclude that butanedione reacts with a critical arginine residue at a site which is separate from formate oxidation and which is involved in the binding of the pyridinium nucleotide cofactor. The procedures reported for chemical modification of this anaerobic enzyme should also be widely applicable in identifying amino acids participating in the catalytic mechanisms of other oxygen-sensitive proteins.

Published
1986
Full Text
View/download PDF

24. Characterization and spectroscopic properties of reduced Mo and W formate dehydrogenase from C. thermoaceticum

Author

Edward I. Solomon, Phyllis J. Wetherbee, Joseph C. Deaton, and Charles N. Durfor

Subjects
Protein Conformation, Inorganic chemistry, Biophysics, chemistry.chemical_element, Tungsten, Formate dehydrogenase, Biochemistry, law.invention, Metal, chemistry.chemical_compound, law, Sulfite oxidase, Electron paramagnetic resonance, Molecular Biology, chemistry.chemical_classification, Clostridium, Molybdenum, Binding Sites, biology, Circular Dichroism, Electron Spin Resonance Spectroscopy, Active site, Cell Biology, Aldehyde Oxidoreductases, Formate Dehydrogenases, Enzyme Activation, Kinetics, Enzyme, chemistry, Spectrophotometry, visual_art, visual_art.visual_art_medium, biology.protein, Nuclear chemistry
Abstract

Formate dehydrogenase (FDH) (EC 1.2.1.43) from C. thermoaceticum has been purified in two forms. One contains tungsten (W), and the other is enriched in molybdenum (Mo). The W-FDH is clearly active, while the Mo results are ambiguous with enzymatic activities generally lower in the Mo-enriched samples. Spectroscopic studies (EPR, absorption, and CD) on W-FDH and Mo-FDH demonstrate that no signal correlates to the group VI metal active site in the dithionite-reduced enzyme. This lack of a W(V) EPR signal is in contrast to the results observed for tungsten-substituted sulfite oxidase which is inactive.

Published
1983

25. Inactivation of L-lactate monooxygenase by nitration with tetranitromethane

Author

Charles N. Durfor and Thomas H. Cromartie

Subjects
Mycobacterium phlei, Biophysics, Flavin group, Biochemistry, Cofactor, Mixed Function Oxygenases, chemistry.chemical_compound, Nitration, Tyrosine, Molecular Biology, chemistry.chemical_classification, Binding Sites, biology, Active site, Substrate (chemistry), Tetranitromethane, Kinetics, Enzyme, chemistry, Spectrophotometry, biology.protein, Oxidoreductases, Methane, Protein Binding
Abstract

l -Lactate monooxygenase is rapidly and irreversibly inactivated by reaction with tetranitromethane at 30 °C by a process which is first order in tetranitromethane and in enzyme. The rate of inactivation is increased by the deprotonation of a group with an apparent pKa of 6.6. Binding of the competitive inhibitors acetate, d -lactate, or oxalate to the enzyme provides essentially complete protection from inactivation. Although excess tetranitromethane and long incubation times result in the oxidation of sulfhydryl groups, complete loss of catalytic activity is accompanied by nitration of a single tyrosine per subunit without polymerization of the enzyme with less vigorous conditions. Nitration of the enzyme results in loss of the ability of the coenzyme to be reduced by substrate, partial loss of the reactivity of the coenzyme toward sulfite, and complete loss of the ability of the apoprotein to bind the flavin cofactor. The essential tyrosine appears to be located at the active site of the enzyme and may be directly involved in the catalytic mechanism.

Published
1981

32. Water requirements of selected industries

Author

Howard L. Conklin, Louis Ethelbert Otts, Faulkner B. Walling, Orville D. Mussey, and Charles N. Durfor

Subjects
Waste management, Smelting, Oil refinery, Water cooling, Environmental science, Raw material, Total dissolved solids, Surface water, Groundwater, Water use
Abstract

The copper industry in 1955 used about 330 million gallons of water per day in the mining and manufacturing of primary copper. This amount is about 0.3 percent of the total estimated withdrawals of industrial water in the United States in 1955. These facts were determined by a survey, in 1956, of the amount and chemical quality of the water used by the copper industry. A large part of this water was used in Arizona, Nevada, New Mexico, and Utah, where about five-sixths of the domestic copper is mined. Much of the remaining water use was near New York City where most of the electrolytic refineries are located, and the rest of the water was used in widely scattered places. A little more than 100,000 gallons of water per ton of copper was used in the production of copper from domestic ores. Of this amount about 70,000 gallons per ton was used in mining and concentrating the ore, and about 30,000 gallons per ton was used to reduce the concentrate to refined copper. In areas where water was scarce or expensive, the unit water use was a little more than half the average. About 60 mgd (million gallons per day) or 18 percent of the water was used consumptively, and nearly all of the consumptive use occurred in the watershort areas of the West. Of the water used in mining and manufacturing primary copper 75 percent was surface water and 25 percent was ground water, 89 percent of this water was self-supplied by the copper companies and 11 percent came from public supplies. Much of the water used in producing primary copper was of comparatively poor quality; about 46 percent was saline containing 1,000 ppm (parts per million) or more of dissolved solids and 54 percent was fresh. Water that is used for concentration of copper ores by flotation or even any water that comes in contact with the ore at any time before it reaches the flotation plant must be free of petroleum products because they interfere with the flotation process. The water used in mining and ore concentration was higher in dissolved solids and was harder than the water used in smelting and refining. Water used in mining and ore concentration had a median dissolved solids content of about 400 ppm and a median hardness (as CaCOg) of about 200 ppm. The median values for water used in smelting and refining were only half these amounts. INTRODUCTION More water is used to produce a ton of copper, on the average, than to produce a ton of any other major metal. This conclusion is obtained from a survey of the quality and quantity of water required by the copper industry. The purpose of this survey and 181 182 WATER REQUIREMENTS OF SELECTED INDUSTRIES similar surveys of other industries is to supply knowledge of water use so that new industrial plants will be able to select sites that are near adequate supplies of water of suitable quality without infringing on the requirements of established industries and other activities with which they will share the available water. This report is limited to a study of the water use of that part of the copper industry concerned with mining copper ores and reducing domestic and imported ores and intermediates to refined copper; it does not include any subsequent processing or fabrication. This study also includes domestic and municipal water for housing and company towns where such facilities were established by the copper companies. The water used in the conversion of new and old scrap metal to unalloyed refined copper is also included because it is usually processed with primary copper and forms an integral part of the refinery output. The investigation began with a review of the literature directed toward finding how much and what kind of water was used by the industry. Previously unpublished results of a 1951 survey of water use by the copper industry are also included in this report. Some quantitative and qualitative water-use information was found in the literature; details are shown at appropriate places in the text. The review of the literature was followed by a field survey in the spring and summer of 1956. The field survey consisted of investigations at mines and leaching and flotation plants that produce the concentrates for about 98 percent of our primary domestic copper. Also the survey included visits to all the copper smelters and refineries in the United States. At each mine or plant, information was obtained on the source of water, adequacy of the supply, temperature of the water, treatment given the water, and any unusual practice in water use and the reasons for such practice. The acquistion of these types of information involved the determination of how much and what kind of water was used at each mine or plant, how the water was used, how much water was used consumptively, how much water was reused, the nature and quantity of the raw materials, and the finished product at each mine or plant. In addition, water from each source was classified as process or wash water, cooling water, boiler feed, sanitary and service, and miscellaneous. Process or wash water is defined as water that comes in contact with an end product or with materials incorporated in an end product. Cooling water is water that is used only for cooling. Under these definitions water used to cool a product by being brought into contact with it is classified not as cooling water but as process water. Boiler-feed water is that introduced into boilers for conversion into steam. Sanitary and service water includes water for drinking

Published
1955
Full Text
View/download PDF

33. Electrochemically-modified glassy carbon electrodes capable of incorporating redox species

Author

Mark L. Bowers, Charles N. Durfor, and Barbara A. Yenser

Subjects
chemistry.chemical_compound, Chemistry, Yield (chemistry), Inorganic chemistry, Oxidizing agent, Electrode, Cationic polymerization, Molecular Medicine, Carbonate, Glassy carbon, Phosphate, Redox
Abstract

Glassy carbon were electrochemically-modified by oxidizing in sulphate, carbonate, or phosphate media to yield electrodes capable of incorporating and concentrating cationic and aromatic redox species.

Published
1987
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results