Experimental biotechnology plant
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.
- (2010). DNA Assay for Recombinant Pharmaceutical Substances Using the Real_Time PCR Technique. Russ. J. Bioorgan. Chem. 36 (1), 104–108 ID:266
(2009). Displacement effect during HPLC preparative purification of human insulin. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci 877 (11-12), 1216–20 [+]
HPLC plays a key role in the preparative purification of human insulin. A21-desamidoinsulin is one of the impurities that possesses the chromatographic behavior similar to that of insulin and hence separation from this by-product is rather difficult at the process scale. During the optimization of insulin reversed-phase HPLC purification, when a column was sufficiently overloaded, the effect of displacement of A21-desamidoinsulin molecules from active groups of sorbent by insulin ones was observed. It was suggested that monocarboxylic acid and organic modifier in mobile phase are responsible for the esterification during which the formed ester promotes the displacement effect. This effect was studied in order to optimize the purification of human insulin at the process scale.ID:263
(2009). [Validation of a method for monitoring of genetically engineered human insulin manufacture]. Bioorg. Khim. 35 (1), 55–61 [+]
A method for monitoring the manufacture of genetically engineered human insulin by HPLC was developed. The method was validated by the estimation of its linearity, correctness, accuracy, specificity, and stability; the limits of detection and quantitative assessment were also determined. It was proven that HPLC analysis enables reliable and reproducible results to be obtained and can be used for monitoring insulin manufacture.ID:262
(2009). [Gene engineered insulin and its pharmaceutical analogs]. Biomed Khim 54 (6), 624–42 [+]
Studies of replacement therapy of diabetes mellitus resulted in introduction of series of forms of insulin and new insulin analogs which exhibit better control of blood glucose level. The present paper deals with basic tendencies in this field.ID:267
(2007). Size-exclusion chromatography based on silica-diol for the analysis of the proinsulin fusion protein. J Chromatogr A 1176 (1-2), 157–62 [+]
Size-exclusion chromatography based on silica-diol sorbent was employed to analyze the recombinant proinsulin fusion protein obtained during the process of refolding and the following ion-exchange purification. The assay was qualified as a control method estimating its accuracy, precision, linearity, limit of detection, limits of quantitation, specificity, and robustness. The results show the reliability for the intended use.ID:261
(2007). Russia through the prism of the world biopharmaceutical market. Biotechnol J 2 (7), 801–17 [+]
Trends in the Russian pharmaceutical biotechnology and related fields representing the major sector of domestic biotech are reviewed through the prism of the world biopharmaceuticals market. A special emphasis is placed on biogenerics and follow-on biologics. The revival of national pharmbiotech is seen in close cooperation between private companies and the state, academia and industry. One of the first positive steps toward promoting development of domestic biopharmaceuticals is the Federal Program of subsidized supply of expensive pharmaceuticals (Dopolnitel'- noe Lekarstvennoe Obespechenie). The program allows the Russian government to purchases expensive drugs to be provided free of cost to certain preferential categories of individuals. As an example, production of recombinant human insulin by the largest Russian fundamental biotechnological institute, Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry under the trademark Insuran (Insulin produced by the Russian Academy of Science) is reviewed. Some prospects and problems of Russian biotech research related to medical area are briefly discussed.ID:264
- (2005). The Effect of Amino Acids as Components of Nutrient Medium on the Accumulation of Protoberberine Alkaloids in the Cell Culture of Thalictrum minus. Russian Journal of Plant Physiology 52 (3), 388–391 ID:265