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project summaries

Organization of production of the NEITROSTIM preparation on the basis of human recombinant granulocyte colony-stimulating factor for the hemopoiesis correction

SRC VB Vector, Koltsovo

Masycheva Valentina

Development of the production of NEITROSTIM. Implementation into medicine practice.

 Larviol ™ - Microbiological preparation against larvae of bloodsucking mosquitoes

Open Joint Stock Company “Institute of Applied Biochemistry and Machine Building ”Biochimmash”, Elvira I. Sokolova

Summary of the project:  Production of advanced technology preparation against larvae of bloodsucking mosquitoes on a basis of Bacillus thuringienis v.israelensis. Improvement of the technology and qualitative characteristics, large-scale manufacturing. Improvement of sanitary conditions of the Russian Federation territories; upturn of the economical conditions; reduction of epidemiological risk of the malaria gene areas; combating with carrier of some diseases such as the West Nile fever in Volga region.

Possible Ways of Cooperation: Investments; joint production

 

The establishing of TB-test collection production for speeded up identification of the Mycobacterium tuberculosis antibiotic resistance

State Scientific Center of the Applied Microbiology & Biotechnology, Obolensk

Lubov V. Domotenko, Mikhail V. Khramov, Tatiana P. Morozova,

Mikhail N. Martovetsky  

Test-collection for speeded up identification of the drug sensitivity and primary M. tuberculosis identification is developed and passes through the State clinical trials. Test-collection consisting of flasks with modifying environment Levenshtain-Yensen can provide to assess the M. tuberculosis sensitivity in 8-10 days. Implementation of this collection in healthcare practice will help to reduce the analysis terms of the drug sensitivity in 2-3 times and to standardize the investigations in different laboratories and regions.

Possible Ways of Cooperation: Cooperation in a field of the production zone establishing, publishing of the methodical instruction.

 

Development of new approaches in the use of immunobiotics: treatment and prevention of respiratory infectious diseases

State Research Institute of Highly Pure Biopreparations, St. Petersburg

L.N. Petrov, T.Ya. Vakhitov, N.B. Verbitskaya

Goals: Reduction of sickness rate and health recovery period after respiratory infectious diseases by the increasing of the organism nonspecific resistance barrier. Development of the immunobiotic of the new generation with increased therapeutic activity in aerosol and lingual forms on a basis of patented lactobacillus strains and regulatory factors.

Tasks: Development of the effective complex immunobiotic and its adequate drug form; investigation of the increase mechanisms of the respiratory tract mucous natural resistance. Conduction of complex of preclinical and clinical trials. Production of a pilot lot of the new complex immunobiotic in aerosol and lingual forms.

Problem to be solved: Reduction of sickness rate for respiratory infectious diseases

Possible Ways of Cooperation: Any possible collaboration with investment to completion of the technology and organization of production.

 

Development of the nanotechnology of immunoactive antibacterial systems

State Research Institute of Highly Pure Biopreparations, St. Petersburg

A.M. Shlyakov, B.P. Nikolaev,  A.S. Simbirtsev

Goals: Decrease of the treatment period for burns, persistent tropic ulcers, and skin surface affection of the infectious, chemical, and radiation etiology.

Tasks:Application of previously discovered technological decisions of the laboratory synthesis of nanodispersed preparation “Intergel”; broadening the preparation receipt formula due to the use of new immunoregulation recombinant proteins; the optimization of receipt; creation of evidential base of the medicinal efficiency of the preparation.

Problem to be solved: Development of effective antibacterial and antiviral preparation with immune correction action for treatment of festering wound of burns origin, persistent trophic ulcers that are very hard to be treated because of the presence of antibiotic-resistant microflora, and also for treatment of external body covering diseases resulting from viral infections (AIDS virus, forms of herpes simplex, chickenpox, herpes and others). Combination of high antibacterial and antivirulent activities of the silver in wide spectrum of pathogenic organisms with saving the cytokines' specific biological activity due to micellar-gel structure of the composition. Stabilization of nanocluster structure of the silver in micellar photostable gel.

Possible Ways of Cooperation: Strategic partnership

 

Production and introduction to clinical practice of xenoaortic frameless prosthetic devices for correction of aortic heart diseases

St. Petersburg State Medical University named by I.P. Pavlov

Vladimir I. Gavrilenkov, Dmitry V. Maslevzcov

Goals: Production of the new model of xenoaortic frameless prosthetic device of aortic valve.

Tasks:To produce the pilot samples of xenoaortic frameless prosthetic devices according to the developed original technology, and to conduct their clinical approbation.

Problem to be solved: Application of the new model of the xenoaortic frameless prosthetic device will allow improving functional results of surgical treatment of the patients with acquired aortic heart diseases therefore improving the quality of their life and further probability of survival.

Possible Ways of Cooperation: Possible cooperation with companies – producers of heart biovalves

 

Conduction of preclinical and clinical trials of microbicidal gel for prevention and treatment of sexually transmitted infections; development of production technology

Open Joint Stock Company “Medical-biological Institute Vector-T”

I.V. Timofeev,  N.G. Perminova, D.I. Timofeev, A.V. Serbin, N.A. Varaksin

Goals: Conduction of preclinical and clinical trials of anti-HIV microbicidal gel.

Tasks: Conduction of preclinical trials, development of clinical trials program and their performing.

Problem to be solved: Sexually transmitted infections control, development of microbicidal gel technology and introduction into the practice.

Possible Ways of Cooperation: Joint preclinical and clinical trials; venture firm

 

Development of the biotechnology of paclitaxel production, the pharmacologically active anticancer substance

Open Joint Stock Company “Institute of Applied Biochemistry and Machine Building ”Biochimmash”

Andrey G. Moshkin

Goals: Development of the biotechnology of paclitaxel production, the pharmacologically active anticancer substance. The biotechnology will allow to develop and produce the new competitive preparation with strongly-marked antineoplastic action

Tasks: Isolation and further selection of callus culture cells of the different type yew-trees with acceptable growth characteristics

Development of the method of testing the paclitaxel content in cell cultures

Development of the method of the paclitaxel isolation from cell culture biomass

Obtaining of suspension cell cultures from selected callus cultures; optimization of their growing conditions

Scaling of the cell cultivating process in big volume bioreactors.

Problem to be solved: Providing the population with vitally important med ical product; creation of additional work-places for the preparation production; saving of rare valuable plants gene pool by using the cell culture instead of intact plants.

Possible Ways of Cooperation: Venture Investment

 

Organization of pilot production of hemosorbent for atherosclerosis treatment

State Research Institute of Highly Pure Biopreparations, St. Petersburg

A.G. Boldirev, A.A.Sokolov,  K.Ya. Gurevich, E.N. Sventitsky

Goals: Implementation to medical practice of selective cholesterol specific hemosorbent for treatment and prevention of atherosclerosis. Development of universal hemocompatible matrix suitable as a basis for the broad range of selective hemosorbents of various specificities.

Tasks: Engineering development of hemosorbent, adaptation of the laboratory technology to the requirements of pilot production;

Development of pilot technology of obtaining the technology for “Spherocell”, a matrix-carrier with targeted parameters;

Development of pilot technology of obtaining the technology for “Sperocell LP-M”, hemosorbent meant for selective deletion of cholesterol and atherogenic lipoproteins (LDL apheresis) from plasma and whole blood, providing regress, stabilization or deceleration of atherosclerosis progression;

Development of standard-technical documentation;

Organization of pilot production division and pilot production of matrix and hemosorbent;

Registration, accreditation, and certification of the pilot production division and produced products; obtaining of other licenses.

Problem to be solved: Atherosclerosis and its manifestation remain one of the main causes of able-bodied people death. LDL apheresis, according to the world practice, is one of the most effective methods of atherogenic disbolism correction that allows gaining not only stabilization or deceleration of atherosclerosis progression, but also the regress of atherosclerotic plaques and vessel lumen repair without surgical operation. Unfortunately the LDL apheresis is not used in Russia because of high cost of foreign technologies.

Possible Ways of Cooperation: Investment to completion of the technology and organization of production. The production division can be registered as a production division of the Institute or as the joint company.

 

Development of new immunomodulators on a basis of endogenous protective peptides

State Research Institute of Highly Pure Biopreparations, St. Petersburg

M. P. Smirnova

Goals: Development of the immunmodulators of the new generation.

Tasks: Development of the new class of immunomodulators on a basis of endogenous protective peptides' analogues.

Problem to be solved: Endogenous “protective” peptides earlier called antimicrobial peptides show the wide spectrum of activity to gram-positive and gram-negative bacteria, fungi, and viruses, they are produced by various tissues, being part of cocktail of antimicrobial factors which synergetically functioning in vivo in a fight against infections. Protective peptides are also responsible for signal connection between innate and adaptive immune systems: actively influence on the induction of proinflammatory cytokines and chemokines, activation and degranulation of mast cells, activation of macrophages, neutrophils, monocytes, and dendrite cells. That's why the use of protective peptides as active immunomodulation component is prospective and actual. On a basis of assessment of correlation structure-immune modulation activity in a line of synthetic analogous of protective peptides we propose to identify the structural rules defining the immunomodulation activity and to develop new non-toxic immunomodulators of new generation.

 

Organization of GMP standards pilot production of the medical preparations on a basis of peptides

State Research Institute of Highly Pure Biopreparations, St. Petersburg

A.A. Kolobov,  N.I.Kolodkin

Goals: Providing of preclinical and clinical trials with medical preparations of peptide origin conducted in Russia and funded by foreign organizations.

Tasks: Production of medical preparations of peptide origin on the production division under the GLP/GMP standards.

Problem to be solved: The market of peptide drugs is assessed as $1 billion with annual predictable increase 10,5%. At the same time there is a volume increase tendency for the research work connected with the development of peptide preparations conducted in Russia by the request of foreign companies. Russian production of synthetic peptide substances and medical products on their basis will allow significantly decrease costs for the research. The production division of peptides' synthesis has been organized in the State Research Institute of Highly Pure Biopreparations. It is necessary to re-equip the division with modern efficient equipment and implement foreign work standards according to GMP standards.

 

Expression of human β and γ interferons in milk of transgenic animals

Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences

Oleg A. Larionov, Vladimir S. Mikoyan, Iriy M. Xodarovich

Goals: Development of effective Russian biotechnology of obtaining of the drug forms' primary components on a basis of human β and γ recombinant interferons for treatment of human dangerous diseases.

Tasks: Obtaining of the transgenic rabbits expressing a human γ interferon (Ifn-γ) gene in milk.

Increasing of the expression level of human β interferon (Ifn-β) in milk of transgenic rabbits.

Obtaining of the transgenic rabbits highly effective expressing both the human β and γ interferons in milk.

Problem to be solved: Gene-engineering construction for Ifn-γ was developed and tested on mice during the preliminary research. The high expression level of γ interferon in milk was obtained on mice (0,5 g/liter in average). Since such vectors are universal, the obtaining of rabbits with high expression of Ifn-γ is only a technical problem. During the previous research the transgenic rabbits expressing Ifn-β have been obtained, but however the level of expression was not enough for commercial use of the interferon. The problem of increasing the level of expression will be solved by using two principally new gene-engineering constructions which also have been developed during the previous research. One of the hybrid gene constructions contains enhancer and SAR-element which by the literature data repeatedly increase the gene expression. The other possible cause is potential toxicity of the Ifn-β for developing embryo. To avoid of Inf – β possible toxic effect and also for use already tested on mice and highly effective vector of Ifn-γ expression, we developed the construction which is composed from the fused genes Inf-β and Inf-γ, and allows simultaneous obtaining of 2 interferons analogous to natural by their aminoacid structure. The two new mentioned gene-engineering constructions allow to solve the problem of increasing the Ifn-β expression level in rabbit's milk.

Possible Ways of Cooperation: We are seeking for a company that will fund the completion of scientific-research works on mutually beneficial conditions. The collaboration with a company that breeds rabbits and has rooms for veterinary surgeon operations conduction and micromanipulator placement is also possible.

 

Collagenase-derived fragments of collagen for ulcer treatment

IMTEK Ltd., Russian Cardiology Research Center/IBCh/MSU

Domogatsky Sergey, Tsybulskaja Maria , Vaskovsky Boris, Ashmarin Georgy, Samonina Galina

Goals: Identification of collagen fragments by means of HPLC and biological effects on several experimental models of ulcer induced on stomach wall in rats (ethanol-, indomethacin-, and stress-induced ulcers) will be the first step with selection of peptides of highest specific activity. Biotechnological procedure for collagen fragmentation and purification of peptides of glyproline family will be developed up to pilot scale production.

Tasks: Ulcer pathogenesis is induced by prevalence of tissue destruction by secreted pepsin in acidic medium over self-protection and reparation processes in the stomach or duodenal mucosal lining. Ulceration results in disruption of protective layer of gastric mucosa following with proteolytic degradation of liable tissues composed of epithelial cells, smooth muscle cells, basal membranes and extra cellular matrix (ECM).

Problem to be solved: Regulation of abnormal collagen metabolism by oral administration of low molecular weight collagen fragments of glyproline family is the anticipated result with potency of pharmacological application. Specific fragments are produced by crab collagenase degradation of native animal collagen followed by fractionation procedure. Pronounced efficiency of collagen fragments for protection against ulcer induction in ethanol-induced mucosal lesions in rats has been demonstrated in our preliminary experiments.

Possible Ways of Cooperation: Contract Research Joint patent protection Joint venture (manufacture)

 

Production of water solutions of antiseptic broad-spectrum preparation “MIRASEPT®” on a basis of new production technologies and quality control of drug products

Open Joint Stock Company “Institute of Applied Biochemistry and Machine Building ”Biochimmash”

Andrey G. Moshkin

Goals: Building the modern production division on the territory of “Biochimmash” for production of water solutions of antiseptic broad-spectrum preparation “MIRASEPT®”.

Tasks:GMP standards modernization of “Biochimmash” production facilities designed specially for this project; purchasing of additional manufacturing and control equipment; justification, receiving of technology documentation and licenses for drug products production.

Problem to be solved: The equipage of pilot production facility with modern technological and control equipment will allow JSC “Biochimmash” to expend the research area on development of new medical purpose biological preparations, will open additional possibilities of funds attraction, and will provide the operational stability of the facility.

Possible Ways of Cooperation: Venture Investment

 

Development of new preparation on a basis of recombinant receptor antagonist of interleukin-1 (ARIL) for treatment of inflammatory, autoimmune, and allergic diseases with aerosol delivery method

State Research Institute of Highly Pure Biopreparations, St. Petersburg

A.M. Ishenko, S.A. Ketlinsky, E.N. Sventitsky

Goals: Development of aerosol forms of ARIL preparation (dry and liquid aerosol), investigation of specific activity of obtained preparations, using them for treatment of patients with psoriasis, atrophic arthritis, psoriatic arthritis, eye allergy diseases, acute pneumonia, and Gravis myasthenia.

Tasks: Development of technology of large-scale production of Il-1Pa substance and aerosol preparation on a basis of the substance;

Investigation of specific activity of aerosol preparations ARIL in model experiments on animals;

Investigation of safety of using the aerosol preparations ARIL (1st phase of clinical trials);

Clinical trials of aerosol preparations ARIL (2nd phase of clinical trials);

Development of standard-technical documentation;

Organization of pilot production division and organization of pilot production of the substance and aerosol preparation ARIL;

Registration, accreditation, and certification of pilot production division and produced products, obtaining of other necessary documents.

Problem to be solved: According to the last nomenclature of cytokines Il-1Pa is put to IL-1 class and named IL-1F3. Il-1Pa is a protein with molecular weight of 16,5 Kd which is produced by many type cells. The expression of IL-1Pa gene is later than Il-1 that shows the existing control Il-1Pa of the level Il-1 production. Biological activity of Il-1Pa is determined by the competitiveness with Il-1 for coupling with a specific receptor which is mutual for both Il-1 and Il-1Pa. At the same time IL-1Pa even if couples with the receptor doesn't take the signal inside the cell. There are several pathologies related to the hyperproduction of IL-1. Keeping of the balance between local levels od Il-1Pa and Il-1 is very important in regulation of potentially dangerous effects of IL-1. In the experiments on animals many positive effects were shown where ARIL was used for treatment of inflammatory and autoimmune diseases where Il-1 plays the key pathogenetic role. Among them are arthritis, colitis, granulomatous lung diseases, injuries, brain damage, etc.

Possible Ways of Cooperation: Investment to completion of the technology and organization of production. The production division can be registered as a production division of the Institute or as the joint company.

 

Combined wound coverings with the properties of artificial skin

State Research Institute of Highly Pure Biopreparations, St. Petersburg

S.F. Antonov, Candidate of chemical sciences, Deputy Head of laboratory; B.A. Nikonov, Deputy director, B.A. Paramonov, Doctor of medical sciences, E.N. Sventitsky, Doctor of technical sciences, Director of the Institute

Goals: Obtaining of the commercial product - combined wound coverings competitive to the foreign analogues. Organization of their production.

Tasks: Comparative research of combined wound coverings and their properties, evaluation of their effectiveness in use for treatment of wounds and trophic ulcer.

Problem to be solved: Wound coverings are intended to the treatment of extensive wounds, persistent wounds, and trophic ulcers. The proposed technology allows obtaining of wound coverings comparable by the efficiency to allogenic skin, but much less expensive and can replace it during the therapy of extensive burns and other skin injuries.

Possible Ways of Cooperation: Any collaboration involving the investment to completion of the technology and organization of production. The production division can be registered as a production division of the Institute or as the joint company; and as a separate venture firm.

 

Development of the new highly efficient immunotherapy method for patients with chronic viral hepatitis C by using the human recombinant interleukin -1 β (Il-1 β)

State Research Institute of Highly Pure Biopreparations, St. Petersburg

S.A. Ketlinsky,  A.S. Simbirtsev, I.L. Ushakova

Goals: Development of liquid drug form of the human recombinant Il-1 β.

Tasks: Evaluation of Il-1 β antiviral action.

Problem to be solved: Development of the effective treatment method for one of the most socially important disease - chronic viral hepatitis C.

Possible Ways of Cooperation: Joint work on realization and promotion of the preparation.

 

Development of combined recombinant vaccine for prevention and treatment of alimentary allergy for cow's milk

Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences

Elena V. Svirshevskaya, Ljudmila G. Alekseeva, Marina A. Shevchenko

Goals: Bringing to clinical trials of vaccines prototypes fo prevention and treatment of allergy on the example of combined vaccine which contains B-cell epitopes of allergens from cow's milk (beta-lactoglobulin and lactalbumin) obtained by recombinant method in yeast virus-like particles (VLP). The technology includes selection of main proteins of allergens to which the response will focus, selection of 2 or 3 peptides from these proteins which are potential B-cell epitopes, expression of the peptides from VLP, introduction of additional vaccine components, providing the VLP delivery through epithelial barrier, and then increasing the recognition by VLP cells of innate immunity.

Tasks: Development of new vaccine against allergy caused by cow's milk.

Adjustment of the effective and convenient method (intranasal, sublingual) of vaccine delivery, namely the development of adjuvant vaccine component that will provide VLP delivery through epithelial barrier, and then stimulation of innate immune system cells that is necessary for effective antigen recognition. The obtained adjuvant can be used for development of any vaccines. Finally, the conduction of preclinical trials which are necessary for the further vaccine implementation into the clinical phase.

Problem to be solved: The starting mechanism of the allergy in most cases is food allergy which is formed in the early childhood. It was shown that 54% of children of early age having food allergy for the main food allergens will have further asthma or / and atopic dermatitis. However the elimination in early childhood of main product groups such as milk causes the significant deterioration of children food. On a basis of this data we believe that it is appropriate to conduct immunoprophylactics of the early allergy forms mostly caused by food allergens that further will allow to decrease a risk of serious allergy forms development caused not only by food , but also by respiratory and common allergens.

 

Development of live culture trivalent flu vaccine

SRC VB Vector, Koltsovo

Nechaeva Elena

Development of the technology of live culture trivalent flu vaccine

Development of anticancer adenovirus preparation "Cancerolisin"

SRC VB Vector, Koltsovo

Sergeev Alexander

Development of the new effective anticancer preparation

 

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