The area of gene therapy has been a growing interest due to its potential of correcting the genetic cause of the disease rather than chronically treating symptoms. Viral vectors have shown to be most successful in delivering therapeutic genetic material into target cells. The progress of these gene therapy programs from early phase through to full commercialization presents various manufacturing challenges.  Extensive optimization of upstream production of viral vectors has led to additional challenges in the downstream process of viral vector manufacturing.<br/><br/>The use of affinity chromatography could help overcome the current challenges in viral vector purification and increase overall product yields. Due to the advantages of highly specific separation and high fold purification, affinity chromatography is a well-established platformable technique for the purification of biomolecules. It delivers significant improvements to the downstream process by reducing the number of purification steps and therefore maximizing productivity, whilst offering scalability and processing consistency.<br/><br/>Herein we outline the benefits of implementing affinity chromatography as platform in the downstream purification of viral vectors, using the CaptureSelect™ technology as the basis of generating high-binding affinity ligands. The methods described will reveal the benefits of affinity chromatography related to specificity, capacity, process yields as well as process scalability for the purification of AAV, Adenovirus serotype 5 (AdV5) and lentivirus viral vectors. Specifically, the properties of POROS™ CaptureSelect™ AAV, AdV5 affinity resins will be discussed as tools to capture and purify a broad range of viral vectors. The utilization of these affinity resins will be a significant improvement to the downstream processing, by reducing the purification steps and maximizing productivity, offering scalability and processing consistency.

Platform approaches for downstream purification of viral vectors to advance manufacturing and commercialization of cell and gene therapies

2019 Spring National Meeting

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