White Paper

Exploring The Future Of Viral Vector Development And Production


The number of viral vector treatments approved by regulators in the last decade, combined with the increasing number of these therapies in various phases of development, has positioned these modalities as the primary delivery mechanism for cell and gene therapies for the foreseeable future. The resulting demand for viral vectors continues to increase, making addressing the challenges related to their manufacturing and scale-up increasingly critical.

As the vehicle that delivers a payload to target cells, viral vectors are subject to a slew of considerations impacting their yields, scalability, and overall optimization. From choosing a vector – and a serotype – to achieving the quality, productivity, and consistency necessary to shepherd an asset through development, the variables that impact viral vector modalities have necessitated greater focus and more novel approaches within the advanced therapy space. For many companies, accessing the expertise needed to optimize around factors such as media feeds, cell densities, vector design, plasmid optimization, process control, and upstream process improvements can unlock new potential for their asset and greatly streamline development.

Ultimately, balancing both upstream and downstream optimization with a right-sized outsourcing strategy is core to establishing viral vector manufacturing that can scale efficiently and achieve commercial success. By working to optimize yield, improve economics, manage the cost and availability of SUTs, and partner with CDMOs and others for expertise and capacity, many small biotechs can streamline their development efforts and better transition from upstream to downstream production. Prioritizing early and frequent regulatory interactions is crucial to the success of many of these therapies, as is working with partners to create efficiencies where possible in a manufacturing process.

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Thermo Fisher Scientific Bioproduction