Managing Contamination Risk While Maintaining Quality in Cell-Therapy Manufacturing

Today, we feature an excerpt from BioProcess International. Dominic Rachel Kilian's article Managing Contamination Risk
While Maintaining Quality in Cell-Therapy Manufacturing was featured in the March 2013 Supplement of BioProcess International.

Managing Contamination Risk While Maintaining Quality in Cell-Therapy Manufacturing

With an increasing number of cell therapies becoming available for patient use, the need for controlled and consistent manufacturing and delivery of cell products is increasingly important. A closed cell culture process not only offers control and consistency, but may also relieve labor demands. Single-use components within a closed process also can reduce contamination risk.

Closed systems with single-use platforms may reduce the risk of biological contamination and cross-contamination that could inadvertently be introduced into cell-culture processes. Such contaminants use culture nutrients to produce unwanted proteins and limit the growth of (or destroy) a cell culture. Slow-growing adventitious agents can be subtle and may become apparent only when unwanted proteins are detected. Detection of contamination will result in unusable product, and depending on the circumstances, entire lots may have to be discarded. This can be incredibly costly in both materials and time. 

Manual cell culture processes can be labor intensive and include numerous open events. They have limited process control, which can lead to difficulties in achieving high reproducibility. Some systems are closed during the stages in which cells are grown. It is equally important, however, to close cell seeding and harvested processes. That is more difficult to achieve, so not as many equipment vendors currently address those additional needs.

Read the rest of the article here. 

If you'd like to find out more about single use technologies and cell therapy bioprocessing, Richard Eglen, Ph.D., Vice President and General Manager, Corning Incorporated, will be on hand at the Cell Therapy Bioprocessing Event to present the technology workshop Optimization of Single-Use Technologies in Cell Therapy.  For more information on this session and the rest of the program, download the agenda.  Would you like to join us in Bathesda, Maryland this coming October 21-22? As a reader of this blog, when you register to join us and mention promo code BX13188JP20, you're eligible to save 20% off the standard rate! 

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