Viral Vector Downstream Processing
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
Viral Vector Upstream Processing
Making the right upstream process decisions not only impacts viral vector titer, but downstream processes, timelines, and regulatory acceptance
Viral Vector Formulation and Final Fill
Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise
Viral Vector Characterization and Biosafety Testing
Critical biosafety testing and characterization of viral vector products can help to fully analyze key quality attributes: identity, potency, safety, and stability
Viral Vector Contract Development and Manufacturing
CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization
Related Technical Resources
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