Agere’s Model-Predictive Platform Enables Bioavailability Enhancement Design & Optimization for Insoluble APIs
Agere Pharmaceuticals, Inc., a leading contract development and manufacturing organization (CDMO), recently announced its proprietary formulation design and development platform focused on solubilization. The system, named Quadrant 2(TM), adheres to quality by design (QbD) guidelines, referencing client requirements for solubility, stability, manufacturability, and performance. It is used from technology selection through formulation optimization, at each stage leveraging design automation and analyses using fundamental science and techniques proprietary to Agere.
Quadrant 2 is designed to enable cost-effective consideration of an expanding spectrum of solubilization options including technologies and excipients, and then to guide scientists in the design and optimization for greater predictability and commercial success. The platform is used on all client formulation projects.
“In designing our system to support client projects, we developed a platform that encapsulates broad and expert formulation and solubilization knowledge with fundamental science to deliver an objective recommendation based on each unique compound,” said Marshall Crew, Agere’s CEO and President. “We can advise each client of the appropriate formulation path so they can more quickly obtain the solution that will best help them achieve their development objectives.”
The new solubilization platform uses proprietary techniques to enable exploration of a larger option space than conceivable using empirical approaches. The shrinking pool of soluble compounds and the growing complexity of formulation design have driven the need for more modern methods of drug design and development, including model-predictive approaches.
“Design automation has been successfully applied to facilitate QbD in other industries, and Quadrant 2 promises to make a significant contribution toward improving the bioavailability of insoluble drugs,” added Ron Rohrer, Chairman of Agere. Dr. Rohrer is a world-renown expert in the modeling and simulation of complex electronic systems. His fundamental work has been successfully applied to various disciplines including chemical engineering.
Pharmaceutical companies facing solubility challenges depend on Agere to enhance the bioavailability of their drugs. Quadrant 2 formulation design, like all client work, is performed on a fee-for-service basis, in which Agere assumes no intellectual property (IP) ownership.
Agere is a leading CDMO focused on improving the oral bioavailability of insoluble active pharmaceutical ingredients (APIs). The company supports clients from screening to identify the optimal solubilization technology, through formulation design and development into cGMP manufacturing for Phase I, Phase II, and Phase IIb clinical trials. All services are delivered on a fee-for-service basis. Agere’s proprietary computer-assisted design platform, Quadrant 2, enables the company to deliver a customized solution for every compound to serve each individual client’s requirements. The company is located in Bend, OR. For more information, visit www.agerepharma.com.
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