Waters Launches SEC Columns for Gene Therapy Applications

Waters Corporation announced the launch of the XBridge Premier GTx BEH size exclusion chromatography (SEC) columns on August 1, 2023. The new SEC columns are designed to improve analysis while lowering the cost of gene therapies, specifically for adeno-associated viral (AAV) vectors.

According to a company press release, the columns aim to reduce the cost of gene therapies by using 3 to 10x less sample, generating faster results, and offering more drug substance information. Additionally, a new multi-attribute quantification method is intended to double analytical speed, quadruple sensitivity, and increase resolution of target analytes by up to 50%.

According to the release, SEC is a technique used for aggregate and fragment analysis in the research, development, and manufacturing of biotherapeutic proteins, such as insulin and monoclonal antibodies. The Xbridge columns are designed to take robust physicochemical characterization and quantitative measurements. Aiming to double the speed of measuring the potency and safety of AAVs, the SEC columns are intended for process development, formulation studies, regulatory filing support, ongoing process monitoring, and quality control.

"We are witnessing a revolution in medicine thanks to gene therapies like AAVs," said Erin Chambers, vice-president, Consumables and Lab Automation, Waters Corporation, in the release. "A small quantity of a gene therapy, such as one of the best-selling eye treatments, can retail for more than $400,000 per eye. This makes it imperative that process and formulation development tests measure multiple attributes of the drug at once while consuming as little of it as possible. It's why Waters' low adsorption … SEC columns are such a good choice for process development, formulation studies, regulatory filing support, along with ongoing process monitoring as well as quality control."

Source: Waters Corporation