Closed downstream systems offer significant advantages, including allowing for multi-product operations and simplified environmental controls. For integrated continuous biomanufacturing (ICB), functionally closed operation becomes imperative to maintain a bioburden-free state through the duration of the operation. We have developed strategies to irradiate chromatography resins while maintaining system performance for large numbers of cycles for affinity and non-affinity resins in mAb and enzyme processes. Irradiated resins can show similar properties to naïve resins depending on the irradiation process parameters. Considerations for GMP implementation will also be discussed. We have also successfully integrated irradiated resins downstream of a large-scale bioreactor with a continuous capture skid with no time-based performance decline for over 40 days, further demonstrating that achieving a functionally closed ICB process is achievable at large scale for extended operations. Such process closure will allow for the development of fully continuous biomanufacturing platforms regardless of bioreactor campaign length and amenable to multi-product facilities.<br/>

Gamma irradiated chromatography resins for functionally closed downstream processing

2019 Spring National Meeting

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