Use of Single-Use Technologies In Downstream Purification of Mabs - A Case Study

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
2011 AIChE Annual Meeting
AIChE Annual Meeting
October 19, 2011 - 8:00pm

The employment of single-use technologies in the downstream processing of biologics in general and monoclonal antibodies in particular is gaining significant traction in the industry. Their use eliminates cleaning validation requirements and can potentially offer significant savings in capital costs and startup time, especially when designing new facilities. Though the advantages of single use technology have been widely talked about, there is relatively little application data, especially with respect to the entire downstream purification train. In this presentation, data will be presented on an entire mAb downstream purification train at 50 – 100 g scale, executed largely using single-use technologies including bags, tubing and filtration assemblies, devices and systems. Data will also be presented on the process development work performed to size the various unit operations.
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