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Manufacture Bioprocessing - Upstream & Downstream

Next Generation Bioprocessing and the Implications for Viral Safety

sponsored by MilliporeSigma

Biomanufacturers are heralding next generation bioprocessing as a way to improve efficiency and productivity, reduce plant footprint and operating costs while maintaining the highest quality standards for the therapies being produced. Compared to traditional batch processing, this new manufacturing paradigm may include higher concentration fluids, higher mass loading of individual unit operations, longer duration processes and connected or continuous processes.

However, maximizing the benefits of this new approach to manufacturing requires consideration of the entire process from a holistic perspective. For example, process intensification using perfusion methodologies results in high density cell cultures that maximize protein productivity in relatively small bioreactors. While this can compress upstream timelines and increase protein yields per unit volume from the bioreactor, downstream operations may struggle to keep pace with higher titers from improved upstream operations.

It is clear that from a process development perspective, we need to consider the implications of efficiency improvements in a single operation in the context of the overall process. Overlaid on this, we may need to rethink how these changes might impact viral safety and how we assess the clearance capabilities of the individual operations.

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About the Authors

Kathy Remington

Kathy Remington is a Technical Consultant focusing on the BioReliance® portfolio at Merck. The life science business of Merck operates as MilliporeSigma in the US and Canada. Merck, BioReliance and BioContinuum are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.


Michael Phillips

Michael Phillips is Director, Next Generation Bioprocessing R&D, at Merck. The life science business of Merck operates as MilliporeSigma in the US and Canada.

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