Waters XBridge Premier GTx BEH SEC columns for gene therapy applications

Waters has introduced the first product in its line of size-exclusion chromatography (SEC) columns aimed at improving analysis while lowering the cost of gene therapies, specifically adeno-associated viral (AAV) vectors.

The Waters XBridge Premier GTx BEH SEC columns are designed to double the speed of measuring the potency and safety of AAVs. Combining the columns with light-scattering technologies from the company’s Wyatt Technology portfolio deepens the level of information acquired from a single experiment and optimises the manufacturing of these novel gene delivery vehicles — quadrupling sensitivity and increasing resolution of target analytes by up to 50%, the company says.

AAVs are modified viruses made in bioreactors by living cells and are a leading vehicle for carrying therapeutic genes into human cells. It is important that process and formulation development tests measure multiple attributes of the gene therapies at once while consuming as little of them as possible.

Waters’ low-adsorption, high-efficiency SEC columns are claimed to use 3–10x less sample than other methods, while generating faster results and more drug substance information. This makes them a good choice for process development, formulation studies and regulatory filing support, along with ongoing process monitoring and quality control.