Viral Vector Downstream Processing

Chromatography graphic representing viral vector purification

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.

Examples include:

  • Ultrafiltration/diafiltration operations, particularly with the use of tangential flow filtration (TFF) for cell or viral harvesting and purification, downstream protein concentration and diafiltration, as well as in final formulation
  • Intensified chromatography processes that reduce the number and size of unit operations, via technologies such as high-productivity, single-use chromatography membrane adsorbers

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.



Workflow

Gene Therapy Manufacturing

Gene Therapy Manufacturing

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





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