Improving Pharmaceutical Product Development and Manufacturing: Impact on Cost of Goods Sold of Pharmaceuticals and Cost of New Drug Development
Pradeep Suresh1, Prabir K. Basu2 and Venkat Venkatasubramanian1, (1)School of Chemical Engineering, Purdue University, 480 Stadium Mall Drive, West Lafayette, IN 47907-2100, (2)Pharmaceutical Technology & Education Center, Purdue University, 315 Hovde Hall, 610 Purdue Mall, West Lafayette, IN 47906-2040 |
Risk Management in the Development of Novel Biomedical Devices and Vaccines
Miguel J. Bagajewicz1, Victoria Froude1, Emily Burdett1, Mark C. Shreve2, Erica Clemente-Harl1, Melissa L. Martin3 and Vassilios I. Sikavitsas4, (1)Chemical, Biological and Materials Engineering, University of Oklahoma, 100 E. Boyd St., T-335, Norman, OK 73019, (2)University of Oklahoma, 100 E. Boyd St. Rm T-335, Norman, OK 73019, (3)Chemical, Biological, and Materials Engineering, University of Oklahoma, 100 E. Boyd St, T-335, Norman, OK 73019, (4)The University of Oklahoma, School of Chemical Engineering and Materials Science, 100 East Boyd, Room T335, Norman, OK 73019 |
High Throughput Cell Culture Development Using the Simcell Platform
A. Peter Russo, BioProcessors, Woburn, MA 01801 |
A Systematic Protein Purification Process Synthesis Strategy
Beckley K. Nfor1, Tangir Ahamed1, Marcel Ottens1, Emile J. A. X. van de Sandt2, Michel Eppink3, Gijs W. K. van Dedem1 and Luuk A. M. van der Wielen1, (1)Department of Biotechnology, Faculty of Applied Sciences, Delft University of Technology, Julianalaan 67, Delft, 2628 BC, Netherlands, (2)DSM Anti-infectives BV, P.O.Box 425, Delft, 2600 AK, Netherlands, (3)DSP, Diosynth Biotechnology Europe, Oss, Netherlands |
A Case Study: Utilization of Antibody Purification Platforms - Impact on Timelines
Nihal Tugcu, David J. Roush and Kent E. Goklen, BioPurification Development, Merck & Co., 126 E. Lincoln Ave., P.O. Box 2000, Rahway, NJ 07065 |
Large-Scale Pool-Less Purification
Joseph E. Shultz1, Samuel Yeboah1, Roger A. Hart1 and John R. Ogez2, (1)Purification Process Development, Amgen, Inc, M/S 30-2-A, One Amgen Center Drive, Thousand Oaks, CA 91320, (2)Quality Assurance Laboratories, Amgen, Inc, M/S 30-2-A, One Amgen Center Drive, Thousand Oaks, CA 91320 |
Regulated Production of Biologically Active Insulin from Engineered Human Skin Substitutes for Treatment of Diabetes
Pedro Lei1, Jun Tian1 and Stelios T. Andreadis2, (1)SUNY at Buffalo, 916 Furnas Hall, Amherst, NY 14260, (2)SUNY at Buffalo, 908 Furnas Hall, Amherst, NY 14260 |
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