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Recombinant Immuno Preparations

#0118


Development of Recombinant and Immunobiological Preparations

Tech Area / Field

  • BIO-CHM/Biochemistry/BiotechnologynMED-DRG/Drug Discovery/MedicinenBIO-CGM/Cytology, Genetics and Molecular Biology/BiotechnologynBIO-MIB/Microbiology/Biotechnology

Status
8 Project completed

Registration date
23.11.1993

Completion date
28.10.1999

Senior Project Manager
Nietzold D

Leading Institute
State Research Center for Applied Microbiology, Russia, Moscow reg., Obolensk

Collaborators

  • Universität Ulm, Germany, UlmnUniversity of Michigan, USA, MI, Ann ArbornUS Department of Health & Human Services / National Institute of Health, USA, MD, Bethesda

Project summary

The objective of the Project is the creation of a novel gene-engineering immunomo-dulating preparations using a-, b-, g-interferones, thymosin a1; tumour necrosis factor b (lymphotoxin); hybrid protein consisting of tumour necrosis factor a and thymosin a1, in order to protect from bacteral and viral infectious diseases, as well as for neoplasma treatment, and for immune status correction of human and animals, too.

The aim formulated above is to be achieved by solving of a series of concrete problems mentioned below.


1. To create high-productive strains of bacteria to produce protein immunomodulator.
2. To optimize cultivation of producer microorganism strains.
3. To develop laboratory technologies for protein immunomodulators isolation and purification.
4. To develop a series of medicine preparations using immunomodulators.
5. To investigate immunological mechanisms of these preparations action.
6. To make pre-clinical trials of the preparations on animals. The problems listed at first can be solved by gene-engineering investigations devoted to appropriate genes synthesis and protein immunomodulators (cytokines) producer strains construction.

High cytokines yields are proposed to be reached by correction of nucleotid compositon of the structural genes according to the producer microorganisms translation procedures, as much as by optimization of the culture growth conditions.

The worldwide experience of preparative biochemistry is be explored during the cytokines isolation and purification methods working out, among them there are:

dissolution in denaturating solvents and protein sedimentation after that, chromatography purification on charged and hydrophobic sorbents, HPLC, gel filtration. Pyrogenic and allergenic properties of the cytokin injectional preparations are proposed to be reduced or to be removed, and new liquid, lyposomal, and tabletted preparations are to make up. Investigation of complex effect of different cytokines on the immune system of experimental animals is planned to be carried out using models of viral and bacterial infections and oncology diseases.

During the Project execution will be created beta-interferon and tumour necrosis factor beta (lymphotoxin) producer strains, biosynthesis, isolation and purification techniques will be elaborated for alpha-, beta-, gamma-interferons, and recombinant tumour necrosis factor beta. These techniques one may use for other gene-engineering immunomodulating drug preparations elaboration. These new cytokin preparations may provide increasing success in curative and preventive actions of Russian Healtn Service. And the elaboration of such kind of new preparations technology will be useful worldwide so far as producer strains created and developed cytokines isolation, purification and stabilization methods are to be not of applied favor only, but also fundamental science one.

The Project described permits the usage of the experience of highly qualified specialists engaged earlier in Defense Research Program as well as laboratory premises and equipment for the development of drugs for human and domestic animals health care.


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