Purification of the immunoglobulins IgM and IgG from human plasma with purity degree for intravenous use

• Grant number: 17/26540-2
• Support type: Regular Research Grants
• Duration: December 01, 2018 - September 30, 2021
• Field of knowledge: Interdisciplinary Subjects
• Principal researcher: Elisabeth Cheng
• Grantee: Elisabeth Cheng
• Home Institution: Instituto Butantan. Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

The need of purification therapeutic proteins from plasma continues to increase in global level, even with the development of a number of the correspondent recombinant products. IgG is currently the most important hemoderivative and is responsible for 50% of the world market. The interest in the plasma derived IgM is increasing due to the increasing of results suggesting that this protein can present anti-inflammatory and immuno-modulatory activities, as well as potential application as tumoral marker. In order to explore all its potential, it is necessary to develop processes to obtain large amounts of IgM, making it available, at low cost, for the realization of clinical trials. In this project we intend to study the purification of immunoglobulins starting with two new strategies.In previous projects our research group developed an efficient method to obtain IgG with high purity (90%). The objective of the first strategy to be explored, therefore, is to improve this process in order to obtain the human IgG with even higher puruty so that it could be used intravenously (purity > 95%). It will be investigated the possibility of using as the second step either a second anion exchange column or a cation exchange column. Since there is no legislation yet for the required purity for the use of commercial IgM, we propose to remove IgA, which is a contaminant protein that is known to have undesirable side effects. For this purpose, it will be investigated the possibility of using a cation exchange column and a gel filtration column. In the second strategy, the objective is to obtain IgM directly from plasma, starting from a fraction collected on the gel filtration column Sepharose 4FF. The advantage of this strategy consists in obtaining the IgM concentrate already in the purification first step. This strategy is interesting when the main objective is to purify IgM. It will be investigated the use of the anon exchange column ANX Sepharose FF and the anion membrane Sartobind Q. (AU)