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Among others delivery systems, lentivirus (LV), and adeno-associated virus (AAV) have emerged as leading platform for gene delivery for treating various diseases, thanks to their excellent safety profile and efficient transduction to various target tissues. The demand for high quality viral vectors that meet standard quality requirements is therefore increasing.
Chemistry Manufacturing & Controls (CMC) for GT represents one of the biggest obstacles towards regulatory approval, posing significant risk to the success of new GT drug candidates. Viral Vector sterilizing filtration remains challenging due to particle sizes, low diffusion rates, and complex molecular surfaces, all influencing vector total recovery yield.
We present how to overcome development and manufacturing challenges for viral vector sterilizing filtration, starting from filter media selection, trough feasibility trials, till process specific validation. This work provides a framework how to move from Quality by Inspection approach to Quality by Design approach, to meet product Critical Quality Attributes.
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