Demand for new gene therapies is challenging manufacturers to seek new ways of accelerating product development and production. Purification processes have historically been based on legacy systems used for monoclonal antibody (mAb) production, requiring large capital and labor investments. The introduction of new technologies for gene therapy production offers the opportunity to increase yield and throughput.
In many documented instances these new downstream technologies have shortened virus purification times from hours to minutes, while at the same time improving product recovery. The result is a cost-effective response to difficult competitive trade-offs, enabling gene therapy manufacturers to achieve easier scalability, a reduced process footprint, and more efficient facility utilization.
The rise of gene therapies is driving rapid innovation, but manufacturers face complex challenges bringing new therapies to life
Making the right upstream process decisions not only impacts viral vector titer, but downstream processes, timelines, and regulatory acceptance
Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise
Critical biosafety testing and characterization of viral vector products can help to fully analyze key quality attributes: identity, potency, safety, and stability
CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization
Article: Scalable Tangential Flow Filtration (TFF) for Downstream Processing of Viral Vectors for Gene Therapy and Vaccine Production
Article: Removing DNA and RNA Using Benzonase® Endonuclease During Viral Production
Article: Strategies for the Separation and Analysis of Empty and Filled Capsids During Viral Vector Production
Application Note: Pellicon® Capsules versus Hollow Fibers for Ultrafiltration/Diafiltration (UF/DF) in Viral Gene Therapy Manufacturing
Product Overview: Ultrafiltration/Diafiltration (UF/DF) of Adeno-Associated Viruses (AAV)
Tech Brief: Evaluation of TFF Operating Control Strategies and Scalability for Viral Vector Process Development
Transcript: The quest for the Holy Grail in AAV chromatography: empty–full separation
Transcript: Shear ignorance? Think again: breaking the perception of shear within viral vector manufacturing
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