Quantification of Process related impurities for Host cell Protein, Leachable Protein A, Host Cell DNA & Bacterial Endotoxin

Abstract

A biosimilar is a medicine which is an identical copy of an Innovator product that is manufactured by a different company. This can be marketed after the patent protection period of innovator product expires. Biopharmaceutical sector have seen considerable advances in recent years, particularly in product characterization methods. During purification process, impurities are removed. These impurities are process or product related impurities. Impurities, such as host cell proteins, host cell DNA, leachables, endotoxins, may cause adverse reactions in humans, and therefore, assays must be employed to ensure that any impurities present are below predetermined acceptable levels. There are various techniques for detection of these impurities. To measure HCP and LPA in the biosimilar, Sandwich ELISA technique has been used in this study. To measure HcDNA PicoGreen method has been used and for detection of bacterial endotoxin, Chromogenic Limulus Amoebocyte Lysate (LAL) method has been used. The overall aim of this dissertation is to work on assays that estimate the impurity profile of the drug substance, this is critical to demonstrate safety and efficacy of the drug.