Raman (Rs) Spectroscopy for Biopharmaceutical Quality Control and PAT. Raw Material - Final Products: the Nanolipids Effect on Signal Intensity. Regulatory and Toxicological Aspects

Authors: Luisetto M*, Nili B, Edbey K, Tarro G, Cabianca L and Oleg Y

DOI: 10.23880/macij-16000175

Volume 6, Issue 1

Abstract

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 (RS) Spettroscopy encapsulating active principle or other substantia unsing different procedure: • Destructive • Non destructive technique. This is relevant because regualtory agency authorized (EMA) for cGMP rules the use also of non destructive methods like RAMAN (RS) spettroscopy in various stage of manifacturing drugs (for raw material and final product).

Keywords: Biopharmaceuticals; M RNA vaccine; GMP; European Pharmacopeia; EMA Procedures; PAT; Quality Control; Raw Material; Final Products; Destructive; Non Destructive Direct Methods; Intensity of Signal; Sample Pre-Treatement of the Sample; Extraction; Toxicology

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