<br/>Capturing the target molecule in downstream processing (DSP) is typically performed by dedicated resin-based chromatography columns. For economic reasons, the lifetime of these columns is used up over many batches, making storage, cleaning, and bioburden control an integral part of their usage. Furthermore, adaptive processing concerning facility utilization and COGs is only possible within narrow limits. Through the use of novel highly productive convective capture devices, e.g. based on chromatographic membranes, capture cycle time is reduced by an order of magnitude (4-8 min per cycle), and a single-batch use mode of operation becomes feasible at full lifetime utilization of the capture membrane (100 cycles in 400-800 min). The column reuse issues mentioned above, along with the relevant validation studies, become obsolete. Single-batch use also avoids life-time underutilization of highly valuable resins during clinical phases. Furthermore, the capture process can be adapted to the actual feed-stream characteristics using the single-batch use mode of operation and optimized for processing time or COGs by choosing the appropriate adsorber bed volume. In this work, we demonstrate the flexibility that the single-batch-mode offers, and analyze the possible processing space concerning overall processing time, number of cycles, bed volume, and COGs. Membrane capture data are compared to a resin chromatography base cases for standard chromatography and pre-packed columns. Furthermore, the use of expert systems and data analytics for operator support will be presented and discussed.

Meeting cost and facility utilization targets through single-batch use of convective membranes for chromatographic capture steps

2019 Spring National Meeting

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