Precision in production: optimizing monitoring and quality control for high-value plasmids

Gene therapy production processes are time-consuming and challenging, and many hurdles in the industry—such as challenges around ensuring regulatory compliance, and lack of industry standardization—are hard to directly influence. However, challenges related to process efficiency can be tackled more easily. This includes analytics, which directly influences product quality, and can save precious time and resources. Traditional UV spectroscopy, commonly used for bioprocess analytics, has limitations such as lengthy assay times, labor-intensive procedures, and susceptibility to errors. Variable pathlength technology, also known as slope spectroscopy, addresses these issues by adjusting pathlengths to maintain a constant concentration and eliminate the need for dilutions. A case study on using the SoloVPE® system to determine plasmid DNA purity ratios will be explored, along with other variable pathlength technology applications across various stages of gene therapy, including fermentation, downstream processing, chromatography, mRNA purity measurements, and AAV titer analysis.