Experimental biotechnological manufacture

Development units

Head: Stepanenko V.N.

Groups in the department: Department of Engineering Process Support, Industrial fermentation workshop, Experimental fermentation workshop, Purification workshop, Medicament preparation workshop, Production and Technical Department

Preparation of recombinant proteins: cultivation in cells; Isolation and purification of recombinant proteins; Obtaining active pharmaceutical substances; Preparation of finished dosage forms

Experienced biotechnological plant (EBP) was established in 2001 on the basis of the Integrated Experimental Installation of the IBCh RAS. It is a research and production platform focused on working with a wide range of partners from large pharmaceutical companies and manufacturers of innovative equipment to universities and start-ups. Thanks to the flexible, modular organization of production parts Experienced biotechnology production, with the assistance of other structural units of the Institute, supports partners at various stages of pharmaceutical development, both innovative products and bio-analogs.

IBCh RAS is the owner of License No. 11719-LS-P dated June 25, 2012 (valid for: perpetually) for the activity on the production of medicinal products.

 

Experienced biotechnological production provides services

• Creation of producers of recombinant proteins and peptides using different expression systems.

• Creation and characterization of banks of strains / cell lines of producers of recombinant proteins.

• Development and scaling of cultivation processes up to a working volume of 1500 liters.

• Development and scaling of the purification processes of the target products.

• Development of technology for obtaining active bio-pharmaceutical substances.

• Development of ready-made dosage forms.

• Development and validation of analytical methods for quality control of APS and GLF.

• Work to study the stability of GLF and APS.

• Services for transfer of the customer's technology, evaluation of its effectiveness and refinement / scaling, both in general and the hotel stages.

• Contract production of the full cycle.

EBP provides a full cycle of genetically engineered pharmaceutical preparations production, as well as preparations obtained by chemical-enzymatic synthesis. The composition of the Experimental biotechnological production includes the units that carry out all the stages of the technological process from the cultivation of the producer cells and the purification of active pharmaceutical substances (APS) to the bottling and packaging of ready-made medicinal forms (GLP).

The organization of control and quality assurance on the EBP is carried out by an independent structural unit – the quality control department. At the EBP stage an effective quality management system has been developed, covering all issues that individually or in general affect the quality of products, and represents a set of organizational measures aimed at ensuring the quality of medicines for their intended use.

One of the main achievements of the EBP is the development and implementation of the first domestic technology for the production of human genetically engineered insulin under the guidance of academician Anatoly Miroshnikov. The launch of production took place in 2004. Technologies for manufacturing high-speed and prolonged ready-made dosage forms of human genetically engineered insulin (the trade mark INSURAN®) were developed at the EBP.

At the EBP platform and with the participation of industrial partners, the development of technologies for the production of growth hormone Rastan®, colony-stimulating factor (trade name Neipomax®) has been carried out.

Now the EBP in partnership with Peptec Company carries out the production of disaccharide from the Micrococcus Lyzodeikticus cell wall, which is a semiproduct in the production of the Likopid® immunomodulator. A number of drugs, including human follicle-stimulating hormone, teriparatide, human insulin analogues, etc., are at different stages of pharmaceutical development.

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Stepanenko V.N.

Russia, Moscow, Ul. Miklukho-Maklaya 16/10 — On the map

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