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Speeding up gene therapy analytics

Schematics of empty, full and partially filled AAV capsids

Genetic Engineering & Biotechnology News (GEN) published a short article discussing how researchers at the UK Centre for Process Innovation (CPI) found mass photometry to be a helpful analytical technique for companies using adeno-associated viruses (AAV) as viral vectors in gene therapies. 


The presence of empty AAV capsids is viewed as an impurity by AAV manufacturers as it reduces the amount of final therapeutically active product, and current techniques for assessing this are considered nonoptimal. So, the researchers tested two new analytical techniques with the aim of increasing their current analytical toolbox for AAV analysis. 


Meeting gold standards


In excerpts from GEN’s article entitled ‘Mass Photometry for Gene Therapy Analytics’, the CPI researchers ‘found that mass photometry performed as well as the gold standard approach—ddPCR titer and ELISA protein capsid titer—for assessing the number of full/empty viral capsids, which is a critical measure of AAV product quality.’ 

 

Furthermore, mass photometry ‘was found to be comparable in accuracy to the ddPCR/ELISA data while being faster. The team uses a mass photometry instrument from Refeyn and believes the technique could be helpful for companies wanting to assess the empty capsid content of their final AAV product.’ 

 

Charlotte Graham, PhD, Team Leader, Analytical, at CPI also confirmed that, “Mass photometry is a high-throughput technique with fast run times in the region of 60 seconds and no need for labelling.” 

 

This article serves to highlight how mass photometry is proving to be useful in addressing the challenges of AAV-based gene therapy vector manufacturing and expediting the measurement of partially filled capsids. 

 

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