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Viral Safety Assurance
 
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Viral Safety for Next Generation mAb Processes

Next generation processing is poised to maximize productivity, flexibility, efficiency, and ease capacity constraints associated with traditional batch processing. Next generation processes may include higher concentration fluids, higher mass loading of individual unit operations, longer duration, and connected or continuous processes. However, leveraging the benefits of this new biomanufacturing approach requires rethinking the entire process holistically to include potential impact to viral safety.



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Virus Detection

Employing newer, faster viral detection technologies is critical to realizing the promise of next generation bioprocessing. Molecular methods such as polymerase chain reaction (PCR) deliver speed and sensitivity, while next generation sequencing (NGS) offers broad detection capabilities and identification of both known and unknown agents.

Our recently introduced Blazar™ rapid molecular platform combines the speed and sensitivity of PCR testing with the broad detection capabilities of NGS and provides biomanufacturers a powerful alternative to traditional in vitro or in vivo virus testing.

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Virus Inactivation

Traditional low pH inactivation operations involve one or more large holding tanks in which product is maintained at a target pH for a specific period of time. Translating this batch operation to a flow-through continuous process requires careful control of both the operating parameters, buffering conditions and low pH viral inactivation technology to assure effective virus inactivation.

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Virus Filtration

Higher concentration intermediates may have more protein aggregates which could impact virus filtration performance. Prefilters can be implemented to remove protein aggregates and improve the capacity of virus filters without additional filtration membrane area. The impact of next generation processing operating conditions on this critical viral clearance step should be carefully considered.

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Viral Clearance through Chromatographic Separation

The higher concentration process intermediates typical of next generation processes could influence the efficiency of chromatographic separation. Viral clearance across purification steps may also be impacted through non-specific interactions of virus with high concentration intermediates or chromatographic media. While many chromatography steps are run more efficiently in next generation processes, the impact of different operating conditions on virus removal should be carefully considered.

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Viral Clearance Studies

Traditional small-scale, viral clearance studies are well-established for batch processing but for continuous processing, they are more complex. For typical batch processes, it is easy to isolate individual process steps and evaluate the viral clearance potential of each step independently. For a continuous process, it is more difficult to isolate each step, and instead of assessing clearance of a homogeneous batch, clearance would be evaluated across a step where the load solution might have varying compositions/concentrations throughout the ‘batch’. Additionally, evaluation of viral clearance may require specialized techniques and equipment, not typically available in testing labs today.

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