lab to commercial manufacturing. The ProCrystal Intellicentic Platform is a generic solution that can be interfaced with different scale crystallizers. It combines PAT and other traditional sensors with adaptive temperature and process control to automatically establish the crystallization metastable zone for any API and create an optimal super-saturation trajectory for the desired particle size distribution and morphology. The system can provide significant improvement in crystallization consistency, and in many cases, a significantly shorter maturity cycle time.
How Intellicentic™ approach differs from traditional biopharmaceutical technologies?
Many traditional manufacturing processes in our industry lead to high costs and increased energy consumption because they lack modern measurement and control capabilities and hence are designed to cope with “worst case” scenarios. This approach results in over-processing, conservative scheduling, and excessive inventories. Intellicentic™ approach is based on modern predictive and adaptive capabilities that enable robust process understanding, enhanced process monitoring, early fault detection and timely corrective actions for process recovery.
The utilization of such technologies does not necessarily result in a regulatory impact, and provide significant potential for improving the manufacturing performance.
According to a document released by the White House, advanced technologies such as our’s “can both revitalize existing manufacturing industries, and support the development of new products in emerging industries.”
Today’s rapid progression of new technologies means
that the design and deployment of smarter, more intelligent systems is easier and more cost effective than ever before. In other words, there has never been a more apt time for manufacturers to invest in improving performance and business metrics.
Is the scope of Intellicentic™ limited to process control? No.
Intellicentic™ offers a multiple of solutions that cover manufacturing at production, plant, and enterprise levels.
At
the process level, Intellicentic™ platforms target yield, cycle time, throughput, and production cost.
At the plant and enterprise
level, the focus is on transforming labor intensive and challenging activities like scheduling, changeovers, resource optimization and inventory and supply chain management.
Te Bioprocessing Timeline: A Note
A note regarding the Bioprocessing Timeline distributed with this issue of American Pharmaceutical Review
Over many centuries, humans have manipulated metabolic processes of organisms or individual cells to create a desirable end product. Bioprocessing allows us to harvest these end products. Before biotechnology was a defined, scientific process, it evolved as a process of carefully implemented, defined cell culture. The historical and scientific developments in bioprocessing have allowed us to guide, engineer, scale, manufacture and ultimately benefit from the products of biotechnology.
Eric Langer (BioPlan Associates), combined with members of the Biotechnology Industry Council, attempted to include many top events that shaped bioprocessing over the past 9,000 years. The speed at which events have occurred over the past 20 years, especially in commercial bioprocessing, suggests this effort will require ongoing input if it is to remain a useful review of events. The timeline is by no means complete, nor fully accurate, given the controversy and timeframes surrounding some of the developments. However, with your help, we will continue to improve its content over time.
Bioprocessing Timeline Coverage: • Early bioprocessing for human benefit • Advances in microscopy • Advances in batch, fed-batch and continuous processing • Discovery of microorganisms • Developments in cellular biology and biochemistry • Historical accounts of a scientifically-manipulated cell culture • Historical detail of cell culture
• Culture of cells for beneficial compounds (e.g., history of penicillin)
• Equipment developed for cell culture (shake flasks, spin tubes, tanks)
• Development of process chains for cell culture • Advances in monitoring and regulating cell culture
• Advances in equipment for monitoring and analyzing metabolic products
• Contamination and quality testing (quality control principles) • Single-use platforms • Advances in cell therapeutics (personalized medicine)
112 |
| September/October 2013 - 15TH
ANNIVERSARY ISSUE
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148 |
Page 149 |
Page 150 |
Page 151 |
Page 152 |
Page 153 |
Page 154 |
Page 155 |
Page 156