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Residual Host Cell DNA Quantitation Evaluating In-House Vs Commercial Solutions

By Mike Brewer & Karen Salomon
The need for speed in biologics development is greater than it has ever been. Regardless of the modality or therapeutic class, there are often multiple companies racing to develop, manufacture, and commercialize high-quality products to be the first-in-class therapeutic. However, there are many manufacturing and analytical challenges that a company can face as it strives to be the first to market. Manufacturers must perform a battery of analytical tests to demonstrate the quality, consistency, purity, potency, and safety of products produced in cell-culture. One of these critical tests is quantitation of residual host cell DNA both during purification and as the product nears final dosage form to ensure the levels of host cell DNA fall below regulatory guidelines. ....

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