Assessing shelf-life of biological drugs
Fluence Analytics has developed a new light scattering biotech product that it says was designed in collaboration with industry to serve as the ideal instrumentation for shelf-life stability studies.
The startup, which provides real-time analytics and control products for companies working in the biopharmaceutical and chemical industries, said the new product is called ARGEN-LT.
It comes with eight independent sample cells that are designed to measure the stability of proteins, peptides, and other biopolymers under thermal, chemical and mechanical stress, it explained.
ARGEN-LT also has a temperature range of 0°C to 100°C, making it a very useful instrument for discovery and formulation development teams performing temporal stability studies at low temperatures to confirm shelf-life viability, said the venture-backed developer.
The company said the product was developed in response to feedback from customers and biopharma industry experts that had been looking for an instrument capable of performing temporal stability studies on biopolymers at low temperature(s) to confirm shelf-life viability.
Fluence Analytics said it recently sold the first ARGEN-LT to a major European biopharma company.
“As the industry continues to grow the pipeline of therapeutics utilizing proteins, peptides, mRNA, and DNA based technologies, assessing shelf-life for these hypersensitive biological drugs is critical to delivering lifesaving treatments to patients around the world. Being able to simulate these conditions, while continuously detecting even the slightest changes in stability, is a significant leap forward. This effort is the culmination of collaboration with global experts and customers to deliver a new tool to the development arsenal,” said Alex Reed, co-founder and president of Fluence Analytics.
