Pharmaceutical Regulatory Affairs: Open Access

Raman Spetroscopy for Biopharmaceutical Quality Control and PAT, Raw Material-Final Products: The Nanolipids Effect on Signal Intensity, Regulatory and Toxicological Aspects

Abstract

Mauro Luisetto*, Nili B. Ahmadabadi, K. Edbey Khaled Edbey, L. Cabianca and Oleg Yurevich Llatyshev

Biopharmaceuticals production is based on a GMP system of quality control used for the regulatory scope. Relvant for this role the analytical procedure, specificity and sensibility of the methods to test raw materials but also the final products before commercialization. Aim of this work is to verify the role played by nanolipids on Raman Spettroscopy encapsulating active principle or other substantia unsing different procedure: 1) Destructive and 2) Non destructive technique. This is relevant because regualtory agency authorized ( EMA) for cGMP rules the use also of non destructive methods like RAMAN spettroscopy in various stage of manifacturing drugs ( for raw material and final product).