NAT Awarded FDA-Sponsored Research Grant “Critical Process Parameters for the Preparation of Amphotericin B Liposomes”

Littleton, MA, Oct. 1, 2016—Neo-Advent Technologies, LLC (NAT) of Littleton, MA, has been awarded a U.S. FDA research grant to evaluate “Critical Process Parameters for the Preparation of Amphotericin B Liposomes.” The objectives of this study are to determine the critical manufacturing process parameters of the liposomal drug amphotericin B using Quality by Design (QBD), as well as to develop and verify analytical methods to test product bioequivalence. The FDA hopes that with this study it will glean the information necessary to assess not only the new wave of Amphotericin B generics that will be shortly hitting the market, but also have the tools to evaluate other new liposomal drug platforms. This research project will strengthen the FDA’s knowledge when advising stakeholders and ANDA sponsors of liposomal products.

CEO Nelson Landrau says, “Neo-Advent Technologies is honored to receive this contract. The methodologies being developed will serve as an important tool for the FDA in evaluating future arrivals of generic liposomal products of amphotericin B, as well as other liposomal drug platforms.”

COO Alex Nivorozhkin adds, “This contract focuses on the full manufacturing schematics and comprehensive panel of related analytical methods for one of the most sophisticated and least understood drug formulation types in the market place. The methodology to be developed in this project will serve as an important tool to support future arrivals of new bioequivalent liposomal products of amphotericin B. We hope that such products will be potent and safe, and will maintain critical importance and superiority in the management of severe fungal infections across the globe.”

Neo-Advent Technologies was founded in 2003 to develop cutting-edge technologies in pharmaceutical and material science.

For more information, contact Nelson Landrau at:

(508) 970-4858
http://www.neoadvent.tech

Neo-Advent Technologies was founded in 2003 to develop cutting-edge technologies in pharmaceutical and material science.