While the concept of gene therapy has been around for decades, active manufacturing of clinical and commercial gene therapies has not seen the benefits of time that monoclonal antibody and other biological products have enjoyed. Consequently, establishing a robust and scalable manufacturing process is a critical focus for AAV manufacturers. One key area that challenges AAV producers is the separation of empty and full capsids during downstream purification. BridgeBio Gene Therapy has explored the impacts of various processing parameters on the consistency of the empty/full capsid separation by anion exchange chromatography using a Bia CIMmultus™ QA column.<br/><br/>To understand the influence of certain parameters, a study was performed on a Bia CIMmultus™ QA monolith column used for full capsid enrichment in the downstream purification of an Adeno-Associated Virus product. Analysis of monolith performance showed that the number of theoretical plates and product loading ratios may have significant impact on process performance. The variability in the observed elution profile demanded careful consideration for scale up and implementation. The knowledge gained from this work informed processing decisions as well as increased confidence in the outputs of the downstream manufacturing unit operations. This work reduced overall process risk and helped establish a more consistent full capsid enrichment step.

Consistency is key: Implementing a monolith for full capsid enrichment of AAV

ACS Spring 2022

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