National manufacturer of
immunobiological products in Russia
En
National manufacturer of
immunobiological products in Russia

Scientific Researches

The scientific potential of SPA «Microgen allows to carry out a full cycle of creating biological products: from the development of a substance, a drug in the appropriate dosage form, conducting preclinical and clinical studies – to release into civilian circulation, as well as carrying out work to improve technology, select a dosage form, optimizing composition and quality control methods of manufactured medicines.

Research areas:


Research and development base

Microgen SPA enterprises have established scientific centers and departments, as well as laboratories equipped with modern analytical equipment, on the basis of which research and development work is carried out.

The department staff that is engaged in scientific activities are proficient in modern technologies of molecular diagnostics based on gene, genomic, proteomic and metabolomic approaches. All work is carried out under the supervision of specialists certified in various laboratory diagnostic methods. The staff of all scientific centers and departments of SPA Microgen consists of more than 70 people, most of whom are highly qualified specialists: candidates and doctors of sciences in the specialized fields.


Key areas:

Vaccines

SPA Microgen enterprises have been developing vaccines designed to prevent infectious diseases for more than a century. In recent years, the company has created several novelties, including:


Blood products

SPA Microgen is Russia's largest producer of blood products of specific and non-specific immunoglobulins and albumin. The company invests in the creation of new blood products against infectious diseases. In particular, recently the following products have been brought to the market:

Only modern viral safety methods, including chromatographic purification technology and nanofiltration, are used for all of the above drugs.


Bacteriophages

Bacteriophage preparations belong to one of the most promising areas of SPA Microgen's work. The company is the only Russian drug manufacturer of this group. To date, the company's portfolio includes 12 international nonproprietary names of bacteriophage preparations, which have a wide range of antibacterial activity.

To prevent the spread of antimicrobial resistance in Russia by 2030, the company is in the process of constructing a collection of bacteriophages strains as part of the government strategy.

In addition, the company develops a methodology for the creation and practical application of bacteriophages in personalized medicine. Basic and applied research in the field of phage therapy is also carried out on the basis of our own scientific center.


Botulinum toxin

RELATOX is the first and only Russian botulinum toxin of type A. Developed by SPA (Scientific production association) Microgen JSC. It is successfully used both in cosmetology and for neurological indications.

The Russian development is used for correction of expression lines, treatment of blepharospasm, spasticity of upper limb muscles after stroke, in hyperhidrosis.

RELATOX is also the first Russian drug based on botulinum toxin used in the treatment of spastic forms of infantile cerebral palsy (ICP) in the age group from 12 to 17 years.

In 2019, SPA Microgen started clinical trials of the toxin to expand its application in the therapy of cervical dystonia, treatment of chronic migraine and urological diseases.

Registration is pending for the new indication of RELATOX for the treatment of focal upper extremity spasticity in adults. Clinical trials for it have already been completed.


Allergens

Today JSC SPA Microgen is the only manufacturer of allergen pharmaceuticals in Russia. The company produces 34 items of self-developed allergens, mixed-allergens, allergoids and mixed-allergoids from tree and grass pollen. Also, SPA Microgen produces 31 products of I.I. Mechnikov Biomed JSC, implemented within the framework of technology transfer to the site in Stavropol.

In 2023, SPA “Microgen” developed and included in the regulatory documentation the first in Russia standard samples of pollen allergens (21 items). This allowed to introduce into the routine quality control of pollen allergen medicines the method of enzyme immunoassay using the company's standard sample.

This makes it possible to switch from in vivo method certification (skin test method) to in vitro method certification (physicochemical analysis method). Also there were developed: methods for the determination of total protein, protein profile by PAGE, and authentication method via Western blot. These methods are included in the specifications for allergen preparations.