Viral vector purification processes have historically been based on systems used for monoclonal antibodies, which are not designed to deliver the necessary level of recovery.
The introduction of new technologies specifically designed for gene therapy viral vector downstream processing offers the opportunity to increase yield and throughput. Among the approaches that can be leveraged to optimize viral vector downstream processing include:
These downstream technologies offer the potential to reduce viral vector purification times from hours to minutes, while improving recovery. In addition, they can facilitate scale-up, reduced the process footprint, and enable more efficient facility utilization.
Our overview of scalable tangential flow filtration for viral vector production will provide key considerations for developing and optimizing your downstream process.
Whether you are developing cell and gene therapies or viral vaccines, removing contaminating nucleic acids is an important part of viral production. The simplest way to do this is to use the Benzonase® endonuclease.
PVA meets all the essential requirements to be used in ophthalmic preparations and offers important benefits compared to HPMC and CMC.
This podcast transcript discusses best practices – and common misconceptions – when establishing process conditions and utilizing different TFF device formats.
This application note discusses methodology and experimental results in the performance evaluation of Pellicon® Capsules versus hollow fibers for UF/DF of viral vectors and describes the impact of either filter type on a TFF process.
Part of the linearly scalable Pellicon® family of TFF filters, single-use Pellicon® Capsules and scale-down Pellicon® XL 50 cassettes provide reliability and reproducibility at any stage of your AAV process, from development to manufacturing
In this technical brief, we discuss use of our new single-use technology for tangential flow filtration (TFF) of viral vectors during the evaluation of two TFF operating control strategies.
This article explains the need for a more nuanced understanding of AAV capture and empty–full separation, and the trends driving innovation in this area.
The crude medium containing viral vectors is depth filtration or a combination of both centrifugation and depth filtration to remove large cellular debris and other contaminants.
Clarified medium from the primary clarification is further purified through additional steps.
Ultrafiltration and diafiltration are used for concentration and buffer exchange, respectively. The viral vector is separated from impurities using size-based filtration. Diafiltration removes salt and other molecules, replacing with the buffer of choice.
At least two chromatography methods are used to purify the viral vector including ion exchange, affinity and size exclusion.
The purified viral vector is subjected to nanofiltration with 15 nanometers pores to remove adventitious viruses, endotoxins, and any other remaining impurities and aggregates.
Sterile filtration, or bioburden reduction, can be used multiple times in the process. The feed stream is passed through a 0.4 or 0.2 micron sterilizing grade filter to remove bacteria and other microorganisms that have been introduced during the processing.
The purified and sterile viral vector is filled into the final intended container. Careful considerations need to be given here for formulation, packaging materials, storage condition to ensure stability and integrity.
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