BIOT 159 |
| Platform Technology has been an accepted approach to antibody purification development for twenty years. There are many advantages to this approach when it works, such as shorter timelines and easier transfers to manufacturing. In the real world, we must deal with issues such as solubility, product variants, fragments, aggregates and other physico-chemical properties inherent to the individual molecule. In many cases, this leads to failure to meet generic timelines that are derived from the concept of “one size fits all”. However, development scientists and engineers must still define operating parameters and unit operations in order to ensure that the process will fit into a manufacturing facility. This is achieved through a flexible platform, defining limits for the number of columns, the number of steps, column capacities, cycles, buffer volumes, etc. It is also important to have defined virus removal and inactivation strategies. Case studies will be presented highlighting “conforming” and “non-conforming” antibodies. |
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Downstream Processing: Purification and Platform Case Studies
3:00 PM-5:30 PM, Tuesday, 12 September 2006 Hilton San Francisco -- Plaza, Oral
Division of Biochemical Technology |