Waters has introduced the first in a new line of size exclusion chromatography (SEC) columns aimed at improving the analysis while lowering the cost of gene therapies, specifically adeno-associated viral (AAV) vectors. The new XBridge Premier GTx BEH SEC columns double the speed of measuring the potency and safety of AAVs. Combining the columns with light scattering technologies from its Wyatt Technology portfolio deepens the level of information acquired from a single experiment and optimizes the manufacturing of these novel gene delivery vehicles.
The new columns are aimed at improving the analysis while lowering the cost of gene therapies, specifically adeno-associated viral (AAV) vectors. They are ideal for process development, formulation studies, regulatory filing support, along with ongoing process monitoring as well as 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. "A small quantity of a gene therapy, such as one of the best-selling eye treatments, can retail for more than US$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 the low adsorption, high-efficiency XBridge Premier GTx BEH 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."
Avid Bioservices (Tustin, California) received early access to the XBridge Premier GTx columns. "The columns significantly widened the dynamic range of our SEC platform method for AAV aggregate analysis," says Kilian Witzel, Senior Scientist, Analytical Development Viral Vectors, Avid Bioservices. "It is now possible to analyse AAV aggregates from small amounts of sample with an HPLC method that is up to five times faster than conventional SEC methods for this application. This will help us expedite study timelines and reduce overall costs."
